by Marion Nestle
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;  
  • 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.