The Latest in Probiotics Research

Episode Intro:

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DrMichaelRuscio:

Hey, everyone. Welcome back to Dr. Ruscio Radio. This is Dr. Ruscio. Let’s jump in on some recent research updates regarding probiotics. I should point out that many pay lip service to staying current regarding a body of scientific literature, or they make these highfalutin statements – “…the science says… the evidence is clear… ” – but, I doubt many actually do as good of a job staying abreast of science as they portray in some cases. I don’t mean to be making too overt of a dig, but it is frustrating when you are someone who actually puts in the time to obsess over staying abreast of what’s being published. Since our last update – maybe four weeks – there have been a number of studies that are impactful and about a dozen that are noteworthy on probiotics. So, let’s go into these updates. By the way, they’re not all updates showing benefit from probiotic therapy, which I should also mention. Let’s jump in. The first study is entitled ‘Changes in the Crohn’s Disease Activity Index and Safety of Administering Saccharomyces Boulardii in Patients with Crohn’s Disease.’ This was a retrospective.

Case Study: Crohn’s Disease & Saccharomyces Boulardii

DrMR:

Looking back in time, there was a cohort (group) of 92 subjects with Crohn’s Disease. This is an autoimmune inflammatory condition in the intestines, often impacting both the small and large, and will manifest as bloating, abdominal pain, frequent stool or sometimes bloody stool. This can be very frequent stools… 10+/day in some cases. In this group of 92 patients, they had received Saccharomyces boulardii for more than six months, or there was a control group (which is really important to point out.) The group receiving the Saccharomyces boulardii was associated with improved disease activity and increased hemoglobin (less bleeding and/or increased absorption of iron.) No changes were noted in inflammatory markers like fecal calprotectin and C-reactive protein or in B12 or folate. So, what we’re seeing here is that Saccharomyces boulardii – a simple, well studied probiotic (actually a healthy fungus) – is associated in improvements with this GI autoimmune condition called Crohn’s Disease.

DrMR:

One thing I should point out as a quick aside – and this is one of the early observations that has helped me develop the scientific heuristic that I use – is to look at outcome data over mechanism. I’ve mentioned this on the podcast before, though it’s been years since I have. However, there was this speculative remark and it permeated many circles in GI: If someone has Saccharomyces cerevisiae antibodies – one of the lab markers used to diagnose inflammatory bowel disease – that are positive, make sure not to give them Saccharomyces boulardii. Well-intentioned, I’m assuming, but what we’re seeing here is an inflammatory bowel disease and we’re seeing benefit from administration on that probiotic. This is just a good example of how a lab marker that looks and sounds scientific when used the wrong way can actually lead you to do the wrong thing.

DrMR:

So, the Saccharomyces cerevisiae is an antibody that can elevate an inflammatory bowel disease – more specifically, Crohn’s Disease. Since this lab marker flags positive, some made the inappropriate and incorrect mechanistic speculation that you should avoid the sister probiotic Saccharomyces boulardii in inflammatory bowel disease – in Crohn’s. Here we have a clinical trial showing that this probiotic actually helps people. So, just one of the many examples of how I/we have come to form some of our beliefs.

Case Study: Synbiotics & Hand, Foot & Mouth Disease

DrMR:

Continuing on with another study entitled ‘Synbiotics Supplements Lower the Risk of Hand, Foot, and Mouth Disease in Children.’ In this study, about 750 children between the ages of two through seven were given synbiotics (a combination of prebiotics and probiotics), and they demonstrated a lower risk of Hand, Foot & Mouth disease (a viral disease.) They also noted that dysbiosis was found in those who had this Hand, Foot & Mouth disease. Yet one more evidence point for how important probiotics can be for children.

Case Study: Bifidobacterium & Dental Cavities

DrMR:

The next study is entitled ‘Effectiveness and safety of Bifidobacterium in preventing dental caries: a systematic review and meta-analysis.’ Now here, the conclusion was probiotics had no effect on streptococcus mutans and lactobacillus counts in the saliva, nor did it impact (more importantly here) the rate of dental caries (or essentially, cavities.) So, one area in which it does not seem that probiotics may help.

Case Study: Bifidobacterium Bifidum & Metformin

DrMR:

The next study is entitled ‘Effects of probiotic Bifidobacterium bifidum on gastrointestinal symptoms in patients with type 2 Diabetes treated with Metformin.’ 40 diabetic patients taking Metformin were given a lacto-bifido blend probiotic. After 10 weeks, there was an improvement in gastrointestinal symptoms in all domains – diarrhea, constipation, et cetera. There was no change in hemoglobin A1C. One of the side effects of Metformin can be gastrointestinal upset and side effects like diarrhea. This study found a decrease in those side effects – not surprising.

Case Study: Probiotics & Depression/Anxiety Disorders

DrMR:

The next study is entitled ‘Probiotics for the treatment of depression and anxiety: A systematic review and meta-analysis of randomized controlled trials.’ In fact, 16 randomized control trials, including 1,125 patients, found that probiotics administration was associated with a significant improvement in depression scores with a moderate degree of certainty and in anxiety scores with a low degree of certainty. So, we’re seeing that probiotics have a favorable effect on mood. It’s important to clarify the nuance that the data here seemed more promising for depression than anxiety. With additional research, perhaps we’ll see a strengthening of that association. There are also important parameters depending on what kind of population you’re looking at. It has been shown that people who have normal moods don’t get extra happy from probiotics, but people who have depression or anxiety seem to experience benefit. Again, the degree of certainty of these findings varies, but it makes more sense that you have more likelihood of a treatment effect in someone who is experiencing some sort of perturbation in their mood (i.e. depression or anxiety.) So, more data here showing that probiotics may help with mood. I wouldn’t say this is the only thing to do, but it’s just great to see how much more evidence is rolling in, especially when there are one or two low-quality data points that have criticized probiotics because they may lead to brain fog, histamine overload or D-lactic acidosis.

DrMR:

I appreciate the papers trying to point out a potential way of helping people, but I think what unfortunately happens there is a growing body of evidence showing patients with depression and anxiety can be helped by probiotics. If you have one or two lower quality data points countering those findings representative of the larger body of data, you actually do inadvertent and probably unintended harm; when people who have depression avoid probiotics because they think that depression is due to – let’s say – histamine. They’re saying, “Well, I’d love to go on a probiotic, but I have histamine issues.” Without going too down this rabbit hole, this is what gets challenging when people are overly presumptive. “Well, I read an article and that article says that brain fog and hives are from histamine overload. Therefore I’m self-diagnosing myself with histamine overload. Now, everything I do is going to be viewed through the frame of histamine. I’m going to avoid intense exercise because I’ve read that can lead to high histamine (by the way, exercise has been shown to be very powerful as an antidepressant.) I’m going to avoid certain foods. I’m going to avoid probiotics…” What’s really disheartening is you’ll see these cases in the clinic where people will be avoiding the exact things that could help them because they’re reading about a mechanism that they think is the most important mechanism to them.

DrMR:

Rightfully so, but this is why we have to have these discussions on the podcast. If you don’t appreciate the net antihistamine or anti-depressive effect of probiotics, you’re missing the bigger point. There may be some minimal impact of these therapies, exercise or probiotics on histamine levels. However, what we’re really after is what is the net outcome for the individual. If it’s net antihistamine and anti-depressive, then for someone who has depression, they should not be avoiding exercise because it can lead to a histamine release and they should not be avoiding probiotics because they may contain small amounts of histamine and actually be net antihistamine. So, just wanted to weave that context in there.

Case Study: Probiotics & UTI’s

DrMR:

Coming over to another study entitled ‘Efficacy of Probiotics as Prophylaxis for Urinary Tract Infections in Premenopausal Women: A Systematic Review and Meta-Analysis.’ Three randomized control trials were examined with 284 participants and probiotics did not have any significant effect in the prophylaxis of UTI’s. There was also a high degree of heterogeneity. This means differences between the studies and reducing how strong of a conclusion can be formed. There is other evidence showing that UTI’s can be treated with probiotics, but treatment and prevention are different. I certainly wouldn’t say there’s any reason to avoid probiotics, but this meta-analysis did not demonstrate any preventative capability of probiotics regarding UTI’s.

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Case Study: Probiotic Triple Therapy & H. Pylori

DrMR:

What about H. pylori? I pause because I’m about to say infection, but I really don’t think infection is the right term to associate to H. pylori. I think dysbiosis would probably be a better term. So, this paper looked at probiotics as a therapeutic against H. pylori. There are just a few quotes here I want to share with you. “Administration of standard antibiotic therapy, combined with probiotics, play an important role in the effective treatment of H. pylori infection.” Another quote: “According to the literature, Lactobacillus casei, Lactobacillus reuteri, Lactobacillus rhamnosus, Saccharomyces boulardii can effectively eradicate H. pylori infection.” Let me say that again – these probiotics alone can effectively eradicate H. pylori infection. We recently published a case study in our FFMR – our clinician’s newsletter – wherein we documented clearance (pre-post stool test clearance) after only using probiotic triple therapy.

DrMR:

I shouldn’t say “only using” because probiotic triple therapy is quite potent and probiotics are quite powerful, but only relative to people thinking that you need antimicrobials or antibiotics to eradicate H. pylori. We also discussed on the last probiotic update podcast, a meta-analysis that found around a 30% cure/effectiveness rate for H. pylori using probiotics. One more quote from this study: “Our results showed that in addition to decreasing gastrointestinal symptoms, probiotics can reduce the side effects of antibiotics, especially diarrhea, by altering the intestinal microbiome.” So, more and more evidence is pouring in showing that probiotics can be a stand alone therapeutic to clear infections. We’ve talked about the growing number (over 20) of clinical trials that have found that probiotics as a monotherapy can eradicate SIBO. In our last podcast on the review of evidence regarding Blastocystis hominis, Flagyl was studied against Saccharomyces boulardii for the treatment of Blastocystis hominis, and there was actually slightly better outcomes using the probiotics than there was the Flagyl (the antibiotic.). We also have this study here, of course, and the meta-analysis for probiotics against H. pylori.

DrMR:

So, a crucially important point and one of the reasons why I am so glad to see more and more providers understanding that when you see some sort of pathogen/potential pathogen or overgrowth (H. pylori, blasto, SIBO) on a stool test or breath test, that does not mean you have to jump right to antibiotics or herbal antimicrobials. I’m hoping that case is becoming more clear for our audience as we see more studies pour in. It’s not to say you couldn’t use a stronger, more noxious approach like herbal antimicrobials or antibiotics, but there is such a thing as overkill. The stronger the treatment, arguably, the more likelihood you could produce a side effect.

DrMR:

Not to mention, in some of these cases, the probiotics are actually stronger. If we’re defining stronger as being better at clearing the infection, my suspicion (this is hard to answer in a study per se), is that the collateral damage from probiotics is vastly lower than antibiotics or antimicrobials. This is namely because probiotics have multiple side benefits like we’ve been discussing. Kids have reduced Hand, Foot & Mouth disease… improved moods… a modest effect on cholesterol… a modest effect on periodontal disease (different than deal carries.) To be fair, antibiotics do also show some side benefits, but if we’re trying to put these therapeutics in a somewhat linear hierarchy, then probiotics will obviously come before herbal antimicrobials or antibiotics. It’s important to understand, especially for patients and clinicians, that you are not being short changed, nor are you short changing a patient if you use probiotics first. Look at all this evidence that is aggregating, documenting their benefit. One more thing here while I’m editorializing – remember that some studies have shown that the antibiotics or the antimicrobials will work better if there’s a co-administration of probiotics. So, why not do a 1-2 stair step – start with probiotics and re-evaluate. If you’ve hit the clinical end point – great, yay, you’re done. If you haven’t quite gotten to the end point that you want to get, your second step is the addition of the antimicrobials or the antibiotics. That is likely going to give you a better outcome and clearance of infection or overgrowth with reduced likelihood of side effects. So much goes into some of the sequencing that we use at the clinic. It’s hard not to get excited about sharing that because the difference in some cases between success and failure is not the magical task or the magical treatment, it’s the sequencing of these therapeutics in order to get the outcome that we’re trying to achieve.

Case Study: Bacillus Coagulans & Fatty Liver Disease

DrMR:

Moving onto the next study entitled ‘The effects of Bacillus coagulans in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial.’ 53 patients with fatty liver were randomized to probiotics or placebo. After 12 weeks, the probiotic group had a greater reduction in serum liver function tests in inflammatory markers and in liver steatosis or fat. Dr. Joe Mather and I recently discussed a case study in which heavy metal burden was reduced after gut work and most namely probiotic triple therapy. I commented that there is evidence showing that liver health, liver enzymes and non-alcoholic fatty liver disease can improve from probiotics. Part of the reason why is likely because what is happening in the gut drains to the liver. Presumably, the more of a mess your gut is, the more of a mess has to be cleaned up by the liver.

DrMR:

If probiotics improve dysbiosis, reduce leaky gut and reduce gut inflammation, that’s going to de-burden how much work the liver has to do. This has lead to some of these improvements we’re now seeing (perhaps for the first time) that the bacillus – or the soil-based/spore forming – type of probiotic has demonstrated this effect.

DrMR:

One other thing I want to flag here in terms of a principle or a philosophy is we want to be careful not to limit our use of probiotics to only where we have studies. I think this is a real mistake. As I’ve discussed in the podcast before, the soil based probiotics are the newest type on the scene regarding the research. So, you’re likely going to see every few months, the first of its kind study where a soil-based categorical type of probiotic (in this case, bacillus coagulans) improves XYZ condition.

DrMR:

So, at some point, there will probably be a mental health study… there’s one we’ll talk about momentarily with constipation. I believe this is the first of its kind showing that soil-based probiotics can improve liver function. The majority of the studies in the past have been consolidated to the most studied category, which is the blends of lactobacillus and bifidobacterium species. Why this is important is so that you don’t get hoodwinked into thinking you need a special and specific probiotic for the health ailment that you have. It’s misusing probiotics. It’s really making them more complicated than they have to be.

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Case Study: Dyspepsia & Spore-Forming Probiotics

DrMR:

Moving on to our next study (didn’t mean to have such a good transition here…) entitled ‘Efficacy and safety of spore-forming (or soil-based) probiotics in the treatment of functional dyspepsia: a pilot randomized, double-blind, placebo-controlled trial.’ Dyspepsia is essentially heartburn, indigestion, an upper GI constellation of symptoms, heartburn, reflux and discomfort. In this study, 68 patients with functional dyspepsia were randomized to soil-based probiotics or placebo. After eight weeks, the probiotic group had a higher rate of clinical improvement: 48% as compared to 20% in the placebo group (a 28% differential between the two.) I am not sure if this is the first of its kind for a soil-based probiotic (or a spore-forming probiotic) in dyspepsia. I believe it is, but I would have to check. As you know, there are hundreds using the lactobacillus-bifidobacterium categorical type. I believe there are 200 using Saccharomyces boulardii and at this point, there are probably 50 or 60 using the soil-based. It’s hard to keep them all straight, even though I try my best.

DrMR:

Kind of an interesting theme here… another study entitled ‘Effect of Bacillus coagulans with Lactulose on Functional Constipation: a Double-Blind Placebo Controlled Study.’ So, it seems there’s progressively more interest in this soil-based (or spore-forming) category of probiotics. You’re seeing more and more positive effects, which further reinforces my point that we don’t need to proclaim that because there was one probiotic formula that contained three different species of these three certain strain designations, that that is the only formula that can ever be used for whatever the positive finding in that study was – let’s say depression. It’s not interpreting the data in a tenured way. If you see study after study after study using different probiotics, all showing the same improvement (let’s say depression again), then you can infer that the probiotic is not working with the drugs. In this study, there actually was not any benefit when looking at lactulose, which is essentially a laxative alone, as compared to another group that received lactulose + the soil-based probiotic. There was a trend in the direction of the probiotic + lactulose group having better regularity, but it was not significantly different from the lactulose alone. So, it’s important to disclose that.

Case Study: Probiotics & Sleep

DrMR:

Another study entitled ‘Effects of Probiotic on Mental Health and Sleep in Healthy Adults: An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial.’ In this study, they used essentially a different iteration of a lactobacillus-bifidobacterium blend probiotic versus placebo in 156 healthy adults. After eight weeks, the probiotic group experienced a significant reduction in depressive symptoms, anxiety and an improvement in sleep quality. Yet another formula that has shown improvements in mood and in sleep.

DrMR:

Again, I want to flag and reiterate that the companies that make these probiotics will market their probiotic with a great piece of science that they’ve produced. It’s incumbent upon clinicians to really stay abreast of the literature and look for these trends – meaning is there a certain probiotic that only works for X/Y/Z condition? Maybe, right? Maybe it actually doesn’t matter to that specific degree, but what’s more important is getting a clinical dose and having a broad presentation (as in probiotic triple therapy.) As you may know, we are currently collecting data with an IBS symptom survey, pre-post triple therapy, a SIBO breath test pre-post and a quality of life measure pre-post. We are hoping to put some scientific documentation behind the fairly clear clinical signal that we’re getting that the triple therapy – meaning three different probiotic formulas – work better than just the one.

Episode Wrap-Up

DrMR:

So, I just want to make sure to mention that I’m harping on the scientific documentation, and we’re now hoping to be the first group to actually document that we can take probiotics a step further than just one formula and use triple therapy. Triple therapy is done for H. pylori… it’s commonly recommended for methane SIBO regarding antibiotics. It’s not an unusual approach to combine a couple different therapies together. We’re just doing that with probiotics. So, in any case, those are a number of updates (about a dozen studies) on probiotics that help us better understand what probiotics can help and where there may be insufficient evidence or just documentation that probiotics cannot help certain conditions (like prophylaxis, prevention of UTI’s or dental cavities.) There is also a growing body of evidence showing that things like sleep, mood and clearance of certain infections in the gut, IBS and regularity can be improved from probiotics.

DrMR:

Perhaps more importantly, it’s not species, blend or strain specific, which is great for consumers. It frees us up to think a bit more critically and try to come up with an empiric formula that works for the individual and not get too bogged down into some of the details.

DrMR:

Well, I hope you guys are enjoying these updates on probiotics. I certainly am. It’s helpful for me to stay abreast of these things, obviously, because it’s one of the mainstays that we use at the clinic. If you are enjoying the show, I would appreciate a quick review over on iTunes. Alright, guys – we’ll talk to you next time.

Outro:

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Changes in the Crohn’s Disease Activity Index and Safety of Administering Saccharomyces Boulardii in Patients with Crohn’s Disease in Clinical Remission: A Single Hospital-based Retrospective Cohort Study

• Retrospective cohort study of 92 Crohn’s Disease patients who had received S boulardii for more than 6 months, and 64 controls
• S boulardii was associated with:
  • Improved disease activity scores
  • Increased hemoglobin
  • NO change in fecal calprotein, CRP, ferritin, B12, folate, or albumin
• Commentary: S boulardii is associated w/ improved disease activity scores independent of inflammatory markers in Crohn’s Disease patients.

 

Synbiotics Supplements Lower the Risk of Hand, Foot, and Mouth Disease in Children, Potentially by Providing Resistance to Gut Microbiota Dysbiosis

• 749 children ages 2-7 yo
• Children who took synbiotics had a lower risk of hand-foot-and-mouth disease (viral)
• Dysbiosis was found in those w/ hand-foot-and-mouth disease

 

Effectiveness and safety of Bifidobacterium in preventing dental caries: a systematic review and meta-analysis

• Probiotics had NO effect on:
  • Streptococcus mutans and Lactobacilli counts in saliva
  • Dental caries rates

 

Effects of probiotic Bifidobacterium bifidum G9-1 on the gastrointestinal symptoms of patients with type 2 diabetes mellitus treated with metformin: an open-label, single-arm, exploratory research trial

• 40 diabetic patients taking Metformin, given lacto/biff probiotic
• After 10 weeks:
  • Improved GI symptoms in all domains (e.g. diarrhea, constipation, etc)
  • No change in A1C

 

Probiotics for the treatment of depression and anxiety: A systematic review and meta-analysis of randomized controlled trials

• 16 RCTs including 1,125 patients
• Probiotics associated w/ a significant improvement in:
  • Depression scores (w/ moderate certainty)
  • Anxiety scores (w/ low certainty)
• Commentary: Probiotics have favorable effects on mood balance.

 

Efficacy of Probiotics as Prophylaxis for Urinary Tract Infections in Premenopausal Women: A Systematic Review and Meta-Analysis

• 3 RCTs, 284 participants
• Probiotics did not have a significant effect in the prophylaxis of UTIs (w/ high degree of heterogeneity)

 

Probiotics as the live microscopic fighters against Helicobacter pylori gastric infections

• “Administration of standard antibiotic therapy combined with probiotics plays an important role in the effective treatment of H. pylori infection.”
• “According to the literature, Lactobacillus casei, Lactobacillus reuteri, Lactobacillus rhamnosus GG, and Saccharomyces boulardii can effectively eradicate H. pylori infection.”
• “Our results showed that in addition to decrease gastrointestinal symptoms, probiotics can reduce the side effects of antibiotics (especially diarrhea) by altering the intestinal microbiome.”

 

The effects of Bacillus coagulans supplementation in patients with non-alcoholic fatty liver disease: A randomized, placebo-controlled, clinical trial

• 53 patients w/ fatty liver randomized to probiotics or placebo
• After 12 weeks, the probiotic group had a greater reduction in:
  • Serum liver function tests
  • Inflammatory markers
  • Liver steatosis

 

Efficacy and safety of spore-forming probiotics in the treatment of functional dyspepsia: a pilot randomised, double-blind, placebo-controlled trial

• 68 patients w/ functional dyspepsia, randomized to soil-based probiotic or placebo
• After 8 weeks, the probiotic group had:
  • Higher rate of clinical improvement (48% vs 20%)
• Commentary: A soil-based probiotic improved dyspeptic symptoms in this study.

 

Effect of Bacillus coagulans Unique IS2 with Lactulose on Functional Constipation in Adults: a Double-Blind Placebo Controlled Study

• 150 patients w/ functional constipation randomized to:
  • Lactulose + soil-based probiotics
  • Lactulose alone
  • Placebo
• After 4 weeks, the soil-based probiotic + lactulose had significant better improvement in stool frequency compared to lactulose alone in the first few weeks
• • However, this difference was not statistically significant after the end of the trial

 

Effects of Probiotic NVP-1704 on Mental Health and Sleep in Healthy Adults: An 8-Week Randomized, Double-Blind, Placebo-Controlled Trial

• 156 healthy adults randomized to lacto/bifido probiotic or placebo
• After 8 weeks, the probiotic group had significant reduction in:
  • Depressive symptoms
  • Anxiety
  • Sleep quality
• Commentary: probiotics can improve sleep quality and mood balance in otherwise healthy individuals.

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