Probiotics are used by millions of Americans to improve gut health, but the scientific evidence for this use is lacking for the vast majority of GI diseases, according to the American Gastroenterological Association (AGA).
New guidelines released Tuesday supported the use of certain probiotic formulations in just a few clinical settings while advising against their use in others based on lack of evidence of effectiveness and safety for common conditions, including Crohn’s disease, irritable bowel disease (IBS), ulcerative colitis, and Clostridioides difficile (C. difficile).
In a technical review of the literature, published with the guidelines in the AGA journal Gastroenterology, the reviewers noted that the absence of regulatory requirements for probiotics — which are mostly considered dietary supplements — limited the ability to compare specific probiotic strains, despite rigorous review involving independent assessment of specific strains or multi-strain formulations using GRADE methodology.
“While our guideline does highlight a few use cases for probiotics, it more importantly underscores that the public’s assumptions about the benefit of probiotics are not well-founded, and that there is also a major variation in results based on the formulation of the probiotic product,” said guideline panel member Grace L. Su, MD, of the University of Michigan, Ann Arbor, in a press statement.
She added that patients taking probiotics for Crohn’s disease, ulcerative colitis, or IBS should consider stopping.
“The supplements can be costly and there isn’t enough evidence to prove a benefit or confirm a lack of harm,” she said.
The guidelines do support the use of certain formulations of probiotics for the prevention of C. difficile infection in adults and children taking antibiotics; the prevention of necrotizing enterocolitis in preterm and low birthweight infants; and the management of the IBS complication pouchitis.
Specifically:
- In adults and children on antibiotic treatment, the guidelines suggest the use of S. boulardii, or the two-strain combination of L. acidophilus CL1285 and Lactobacillus casei LBC80R or the three-strain combination of L. acidophilus, Lactobacillus delbrueckii subsp. bulgaricus, and Bifidobacterium bifidumL. acidophilus, L. delbrueckii subsp. bulgaricus, B. bifidum, and Streptococcus salivarius subsp. thermophilus over no or other probiotics for prevention of C. difficile infection (Conditional recommendation, low quality of evidence).
- In preterm (less than 37 weeks gestational age), low birth weight infants, the guidelines suggest using a combination of Lactobacillus spp. and Bifidobacterium spp. (L. rhamnosus ATCC 53103 and B. longum subsp. infantisL. casei and B. breveL. rhamnosus, L. acidophilus, L. casei, B. longum subsp. infantis, B. bifidum, and B. longum subsp. longumL. acidophilus and B. longum subsp. infantisL. acidophilus and B. bifidumL. rhamnosus ATCC 53103 and B. longum Reuter ATCC BAA-999; or L. acidophilus, B. bifidum, B. animalis subsp. lactis, and B. longum subsp. longum), or B. animalis subsp. lactis (including DSM 15954), or L. reuteri (DSM 17938 or ATCC 55730), or L. rhamnosus (ATCC 53103 or ATC A07FA or LCR 35) over no and other probiotics (Conditional recommendation, moderate/high quality of evidence).
- In adults and children with pouchitis, the AGA suggests the use of the eight-strain combination of L. paracasei subsp. paracasei DSM 24733, L. plantarum DSM 24730, L. acidophilus DSM 24735, L. delbrueckii subsp. bulgaricus DSM 24734, B. longum subsp. longum DSM 24736, B. breve DSM 24732, B. longum subsp. infantis DSM 24737, and S. salivarius subsp. thermophilus DSM 24731 over no or other probiotics (Conditional recommendation, very low quality of evidence).
The review showed little support for the use of probiotics in children in North America with acute gastroenteritis, and the guidelines state that they should not be given routinely to pediatric patients who present to emergency departments with diarrhea.
Review authors Geoffrey Preidis of Texas Children’s Hospital, Houston, and colleagues, noted that guidelines from other organizations, including the Infectious Disease Society of America, previously recommended the use of probiotics in this population.
“These guidelines were developed without utilizing GRADE methodology and also relied on data outside of North America which became available after the recommendations were made,” they wrote, adding that “this is an area that will require further study and recommendations evolve as more direct high-quality data becomes available.”
Preidis and colleagues concluded that high-quality studies are “urgently needed” to address the clinical evidence limitations identified in the review.
They noted that the newly published guidelines will be reviewed and updated in the event that practice-changing evidence becomes available.
“We identified that significant knowledge gaps exist in this very promising and important area of research due to the significant heterogeneity between studies and variability in the probiotic strains studies,” they wrote. “The lack of consistent harms reporting makes it difficult to assess true harms. The lack of product manufacturing details prohibits true comparisons and decreases the feasibility of obtaining certain products by patients.”
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New AGA guidelines advise against the use of probiotics for common conditions including Crohn’s disease, irritable bowel disease (IBS), ulcerative colitis, and Clostridioides difficile (C. difficile).
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The guidelines do support the use of certain formulations of probiotics for the prevention of C. difficile infection in adults and children taking antibiotics; the prevention of necrotizing enterocolitis in preterm and low birthweight infants; and the management of the IBS complication pouchitis.
Salynn Boyles, Contributing Writer, BreakingMED™
The guidelines and technical review were funded by the AGA Institute.
Researcher Adam Weizman reported receiving financial support/renumeration from AbbVie Inc, Janssen Pharmaceutica, Takeda, and Ferring Pharmaceutical. Researcher Purna Kashyap reported serving on the advisory board of Novome Biotechnologies and being an ad hoc consultant for Otsuka Pharmaceuticals and Pendulum Therapeutics. Researcher Premysl Bercik reported receiving financial support/remuneration from Nestex Ltd, Allergan Canada, IM HealthScience LLC and LUPIN Pharma Canada Ltd.
No other financial disclosures were reported.
Cat ID: 188
Topic ID: 77,188,730,188,20,21,192,925
