by Marion Nestle

Currently browsing posts about: Probiotics

Jun 10 2024

Industry-influenced study of the week: probiotics and vaginal microbiome

I learned about this study from this account.

Probiotics may improve vaginal microbiota in postmenopausal women: A specific combination of probiotic strains may restore vaginal microbiota and relieve vaginal distress in postmenopausal women, according to a new study from Italian probiotic manufacturer SynBalance…. Read more

High marks to indicating industry sponsorship right up front.

The study: Efficacy of Lactiplantibacillus plantarum PBS067, Bifidobacterium animalis subsp. lactis BL050, and Lacticaseibacillus rhamnosus LRH020 in the Amelioration of Vaginal Microbiota in Post-Menopausal Women: A Prospective Observational Clinical Trial. Nutrients 2024, 16(3), 402; https://doi.org/10.3390/nu16030402.

Method: “Subjects were supplemented with a probiotic product containing Lactiplantibacillus plantarum PBS067 (DSM 24937), Bifidobacterium animalis subsp. lactis BL050 (DSM 25566), and Lacticaseibacillus rhamnosus LRH020 (DSM 25568; all from SynBalance Srl, Origgio, Italy)…Women were asked to consume 1 capsule/day, away from meals, for 4 consecutive weeks. Assessments of health status were carried out at the starting point of the study (T0), after 4 weeks of oral probiotic supplementation (T1), and after a 4-week follow-up.”

Results: “Clinical outcomes revealed a decrease in menopausal symptoms. Significant improvements were observed across various parameters…Moreover, the probiotic intervention facilitated the restoration of vaginal microbiota, evidenced by an increase in lactobacilli abundance.

Conclusion: “the combination of these specific probiotic strains, previously clinically tested in childbearing-age women, showed to be effective also for post-menopausal women.”

Conflicts of Interest: “Authors P.M. and D.F.S. were employed by the company Synbalance Srl. Authors E.V., A.M. and A.C. were employed by the company Wellmicro Srl. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.”

Comment: Employees of the company making the probiotic supplement conducted this uncontrolled observational study.  The supplement made study subjects feel better and improved their microbiomes.  But compared to what?  The study had no control group.

In addition:  While we are on the subject of probiotics, I’m quoted in a New York Times article about probiotic supplements in beverages.

Prebiotic sodas aren’t likely to harm your health, Dr. Nestle said, but it’s also not likely that they’ll be beneficial.

“Really, if people are concerned about their microbiome, they need to eat vegetables,” Dr. Nestle said. “Vegetables would do wonders.”

Nov 27 2023

Industry-funded study of the week: a bacterial probiotic supplement and indigestion

This one started out with a notice in NutraIngredients Europe, a newsletter I subscribe to:

Probiotic BG01-4 relieves constipation and discomfort in GI disorders: Probiotic BG01-4 improves specific symptoms of constipation and related GI dysfunction in people with self-reported functional gastrointestinal disorders (FGID), which affects a significant percentage of the global population, a new study concludes…. Read more

That title triggered my usual question, “Who paid for this?”

I went right to the study:

  • The study:  Bacillus Subtilis (BG01-4TM) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial,by Craig Patch, Alan J. Pearce, Mek Cheng, Ray Boyapati, and Thomas Brenna. Nutrients202315(21), 4490; https://doi.org/10.3390/nu15214490.  
  • Background: Functional gastrointestinal disorders (FGIDs) are common, difficult-to-manage conditions. Probiotics are emerging as a dietary component that influence gastrointestinal (GI) health. We conducted a double-blinded randomised controlled trial of a proprietary strain of deactivated Bacillus subtilis (BG01-4™) high in branched-chain fatty acids (BCFA) to treat self-reported FGID.
  • Methods: Participants (n = 67) completed a four-week intervention of BG01-4™ (n = 34) or placebo (n = 33). The Gastrointestinal Symptom Rating Scale (GSRS) served as the outcome measure, collected prior to, at two weeks, and at four weeks after completion of the intervention.
  • Results: At four weeks, one of three primary outcomes, constipation in the experimental group, was improved by 33% compared to placebo (15%); both other primary outcomes, Total GSRS and diarrhoea, were significantly improved in both the experimental and placebo groups (32%/26% and 20%/22%, respectively). The pre-planned secondary outcome, indigestion, was improved at four weeks (32%) but compared to the placebo (21%) was not significant (p = 0.079). Exploratory analysis, however, revealed that clusters for constipation (18% improvement, p < 0.001), indigestion (11% improvement, p = 0.04), and dyspepsia (10% improvement, p = 0.04) were significantly improved in the intervention group compared to the placebo.
  • Conclusions: These initial findings suggest that in people with self-reported FGID, BG01-4™ improves specific symptoms of constipation and related GI dysfunction. Longer-term confirmatory studies for this intervention are warranted.
  • Conflicts of interest: C.P., M.C. and J.T.B. are directors of Adepa Lifesciences. The other authors declare that they have no conflicts of interest regarding the publication of this paper.

Comment: Three of the authors are involved with the maker of this supplement, Adepa Lifesciences, which makes this look like a marketing study.  It is published in the journal, Nutrients, an open-access journal.  Sharp eyed readers of this blog might notice that a large proportion of my industry-funded studies of the week appear in this journal.  It has an interesting policy.  It is fully open access and charges authors a fee accordingly.  That fee amounted to $3200 on October 30). 

All articles published in Nutrients (ISSN 2072-6643) are published in full open access. An article processing charge (APC) of CHF 2900 (Swiss Francs) applies to papers accepted after peer review. This article processing charge is to cover the costs of peer review, copyediting, typesetting, long-term archiving, and journal management. In addition to Swiss francs (CHF), we also accept payment in euros (EUR), US dollars (USD), British pound sterling (GBP), Japanese yen (JPY) or Canadian dollars (CAD).

Many science journals charge fees for open access, but usually offer authors a choice.  For the record, I have never paid to have an article published.

Jul 5 2021

Industry-sponsored study of the week: Prebiotics

I read about this one in NutraIngredients.com.

While previous animal studies have suggested a significant impact of the gut microbiota on the development and maturation of brain networks that underlie emotional behaviour, fewer studies have been conducted on humans. Intake of a galacto-oligosaccharides (GOS) prebiotic over 3 weeks has been shown to lower the secretion of the stress hormone cortisol and emotional processing in healthy adults, suggesting that GOS intake may be useful in modifying anxiety-related psychological mechanisms. However, reviews and meta-analyses on the efficacy of prebiotics for reducing anxiety symptomology are mixed, calling for further well controlled trials in human participants.

I am always curious to know who pays for this kind of research, so I looked up the study.

Anxiolytic effects of a galacto-oligosaccharides prebiotic in healthy females (18-25 years) with corresponding changes in gut bacterial composition.  Nicola Johnstone Chiara Milesi Olivia BurnBartholomeus van den BogertArjen Nauta Kathryn Hart Paul SowdenPhilip W J BurnetKathrin Cohen Kadosh.   Sci Rep 2021 Apr 15;11(1):8302.

The study: “We examined multiple indices of mood and well-being in 64 healthy females in a 4-week double blind, placebo controlled galacto-oligosaccharides (GOS) prebiotic supplement intervention and obtained stool samples at baseline and follow-up for gut microbiota sequencing and analyses. We report effects of the GOS intervention on self-reported high trait anxiety, attentional bias, and bacterial abundance, suggesting that dietary supplementation with a GOS prebiotic may improve indices of pre-clinical anxiety.”

Conflict of interest statement: AN is an employee of FrieslandCampina, Amersfoort, The Netherlands. BvdB reports co-ownership of MyMicroZoo, Leiden, The Netherlands with no financial benefit from contributions to this manuscript. NJ, CM, OB, KH, PS, PWJB and KCK declared no financial or potential conflicts of interest.

Comment:  Probiotics are microorganisms that maintain a healthy microbiome.   They are typically found in fermented foods like yogurt.  Prebiotics are substances in food—or, in this case, supplements—that feed probiotic microbes.  This prebiotic supplement is GOS, a complicated chain of sugar molecules that is found in milk.

Why would an employee of FrieslandCampina want to do this study?  “Milk is the foundation of everything we do at FrieslandCampina.”

Why would a co-owner of MyMicroZoo be interested?  “The MyMicroZoo analysis shows the composition of your microbiota, and gives insight into how to improve your vitality.”

I’m all for eating yogurt (but watch out for the added sugars).  But GOS supplements?  Pardon my industry-induced skepticism.

Dec 21 2020

Food marketing ploy of the week: PepsiCo

My colleague, former doctoral student, and frequent correspondent, Dr. Lisa Young, sent me this choice item:

Now why would PepsiCo be interested in putting money into a conference on fermented foods?

Lisa has the answer to that one too: the company just bought a company that makes fermented beverages.

PepsiCo, Inc. (NYSE: PEP) announced today that it has entered into a definitive agreement to acquire KeVita, a leading North American creator of fermented probiotic and kombucha beverages. The transaction will expand PepsiCo’s health and wellness offerings in the premium chilled beverage space.

I’ll bet speakers at that conference talked a lot about the purported health benefits of drinks like these.  And I’ll also be willing to bet that they did not talk about studies that show no benefit.

Just a wild guess.

Jan 23 2020

What’s Up with the Microbiome?

NutraIngredients.com, one of those industry newsletters I follow closely, publishes numerous articles on probiotics, gut health, and the microbiome.  I have a few examples here, but let’s start with this one:

Postbiotics?  For this, a glossary may help:

  • Probiotics:  Beneficial microbes in the intestinal tract
  • Prebiotics:  Food substances that promote the growth of probiotics
  • Synbiotics:  Probiotics and Prebiotics together
  • Postbiotics:  Bioactive substances produced by probiotics (e.g., microbial cells, cell constituents, metabolites).
  • Parabiotics:  Heat-killed microorganisms

More articles on these topics:

And Natural Products Insider has a report on prebiotic supplements available for downloading.

Jun 20 2019

Kombucha: A collection of industry articles

FoodNavigator-USA.com, an industry newsletter, has a collection of articles about Kombucha, a drink that Wikipedia defines as:

A fermented, slightly alcoholic, lightly effervescentsweetened black or green tea drink commonly intended as a functional beverage for its supposed health benefits. Sometimes the beverage is called kombucha tea to distinguish it from the culture of bacteria and yeast.  Juice, spices, or other flavorings are often added to enhance the taste of the beverage. The exact origins of kombucha are not known…Kombucha is produced by fermenting sugared tea using a symbiotic culture of bacteria and yeast (SCOBY) commonly called a “mother” or “mushroom”…The living bacteria are said to be probiotic, one of the reasons for the drink’s popularity.

Slightly alcoholic?  No wonder it is so popular.

It’s obviously a major seller.  Here is the dedicated Kombucha display at the Wegmans upstate in Ithaca, New York.

The makers of kombucha want to sell more of it.  Here’s what they think the market issues are these days:

And here’s a later addition:

Dec 6 2018

Do probiotics work? Maybe, if you are lucky

The industry newsletter, NutraIngredients.com, regularly posts Special Editions on Probiotics, meaning collections of its articles on the topic.  These promote the benefits—to digestion and many other physiological and mental aspects—of eating healthy bacteria.   But do probiotics really work?  And could they actually be harmful?  See comments below these selected articles.

Two recent articles in Cell raise questions about the benefits of probiotics.

In translation:

  • The murine [mouse] & human gut mucosal microbiome only partially correlates with stool
  • Mice feature an indigenous-microbiome driven colonization resistance to probiotics
  • Humans feature a person-specific gut mucosal colonization resistance to probiotics
  • Probiotic colonization is predictable by pre-treatment microbiome & host features

In further translation:

  • Not everyone responds to probiotics, which means that they may be worth a try and you may get lucky.

And an even more recent article in JAMA Internal Medicine questions whether probiotics might be harmful.  It warns about:

  • The safety of bacteria in probiotic supplements has not been fully established.
  • They can lead to infections and allergic reactions.
  • Probiotic supplements often do not meet manufacturing standards (identity, purity, strength, composition).
  • Introduction of new genes for antibiotic resistance into microbiomes.

The article concludes:

Consumers and physicians should not assume that the label on probiotic supplements provides adequate information to determine if consuming the live microorganism is worth the risk.

What to think about all this?  If you like yogurt, enjoy!  But supplements are another matter.

May 3 2018

FoodNavigator-USA on fiber, probiotics, and digestive health

This is one of FoodNavigator’-USA’s ongoing series of collected articles on specific topics from a food-industry perspective, in this case, digestive health.

Special Edition: Digestive health

Digestive health used to revolve around roughage, but as understanding of the relationship between our gut and our overall health has grown, consumers are now exploring everything from prebiotic fibers and probiotics to a new wave of fermented foods or simply avoiding foods that make them feel bloated or lethargic. We explore how consumers are thinking about gut health and how manufacturers can tap into demand for foods that make our microbes happy.