AGA issues guidelines for probiotics for sick, at-risk populations

By Stephen Daniells contact

- Last updated on GMT

© Getty Images / ayo888
© Getty Images / ayo888

Related tags: Probiotics

The American Gastroenterological Association has released guidelines for a range of conditions, with strong support for necrotizing enterocolitis in infants and for the prevention of C. difficile infection in adults and children who take antibiotics.

The guidelines, which were published in the AGA’s journal Gastroenterology,​ also support probiotics for the management of pouchitis, a complication of ulcerative colitis that has been treated surgically.

However, AGA is dismissive of probiotics for multiple conditions, from treating C. diff​ to Crohn's disease, ulcerative colitis or IBS.

AGA issued a press release​ stating, “After conducting a detailed review of available literature, AGA has released new clinical guidelines finding that for most digestive conditions there is not enough evidence to support the use of probiotics.”​  This led to mainstream media coverage with headlines such as, “Probiotics Don't Do Much For Most People's Gut Health Despite The Hype, Review Finds”​ (CNN​ and then syndicated extensively across other outlets).

IPA: “Points of discussion, celebration, and contention”

The guidelines, and implied relevance to probiotic supplements in general (the AGA press release makes reference to supplements), has been met with differing responses from probiotic stakeholders.

The International Probiotics Association (IPA) said the guidelines “contain some points of discussion, celebration, and contention for the probiotic field”​. IPA issued an extensive three-page release discussing the guidelines​.

The association welcomed the AGA’s focus on individual strains and for “not grouping different probiotic strains and combinations of strains into one meta-analysis”​.

IPA also heralded the “hard-earned wins”​ regarding AGA’s recommendations for NEC, C. diff​ infection (CDI), and pouchitis, while noting, “It thus appears that the AGA recommends probiotics for some gastrointestinal conditions as a drug; to prevent, cure and treat disease. Much evidence for probiotics substantiates their use to support health and in preventing and mitigating disease and in a wider scope of conditions.”

“The AGA has looked at probiotics through the lens of pharmaceuticals,” ​added IPA.

“AGA is looking for drug-level evidence”

Mary Ellen Sanders, PhD, from Dairy & Food Culture Technologies, stressed to NutraIngredients-USA that AGA did not issue a guidelines document on probiotic dietary supplements, but on probiotics. There is nothing in the probiotic definition that limits probiotics to dietary supplements or foods, she said. Probiotic drugs are still probiotics.

“So, to the extent that AGA is considering probiotics to treat disease or to use in unhealthy, at-risk populations, it is not unreasonable for them to assess based on drug-level evidence. In fact, many (although certainly not all) of the studies conducted on probiotics over the years are on drug endpoints (treatment of acute pediatric gastroenteritis, treatment of IBS, prevention of NEC).

“I think we can all agree that it is useful that the evidence base for probiotics is critically and systematically reviewed in an unbiased manner. However, reasonable people may look at the same evidence but conclude differently with regard to what quality and level of evidence is needed to justify a recommendation. AGA is looking for drug-level evidence.

“Other clinicians may conclude that although the evidence has limitations, considering the safety profile of traditionally used probiotics, there is likely little harm and benefit – based on limited but existing data – may be realized by individuals.”

“Pretty exciting stuff”

Dr Daniel Merenstein, Professor of Family Medicine at Georgetown University, said that while the guidelines do not address probiotics for general GI health, he reads them as recommendations for nearly all hospitals and doctors to now know a few good probiotics and for probiotics to become a regular part of their armamentarium.

“It states for preterm (born before 37 weeks), low birth weight (< 2500 g) infants, specific probiotics can prevent mortality and necrotizing enterocolitis, reduce the number of days required to reach full feeds, and decrease the duration of hospitalization. They also recommend them for CDI prevention,” ​said Dr Merenstein. “This is pretty exciting stuff as I don't ever remember such a well-known group making such clear recommendations.”

Drs Merenstein and Sanders are members of the board of directors of the International Scientific Association for Probiotics and Prebiotics (ISAPP). ISAPP's response to the AGA guidelines can be found HERE​.

CRN: “The guidelines are in no way as a dismissal of the category altogether”

Andrea Wong, PhD, senior vice president, scientific & regulatory affairs at the Council for Responsible Nutrition (CRN), said that the new clinical practice guidelines directed toward doctors in no way diminish the important role probiotic supplements play in maintaining digestive health, nor do they give reason to disregard this category’s history of safe use.

“The guidelines are for the management of specific gastrointestinal disorders and are not recommendations for the generally healthy population,” she said. “It is critical to underscore the difference between using a probiotic to treat a specific disease and the general use of probiotics in foods or dietary supplements to support digestive health.

“CRN notes the guidelines identify areas where more high-quality evidence is needed before the AGA would recommend probiotics for treating specific diseases; it does not offer evidence that probiotics should not be used in dietary supplements or foods. Therefore, we recommend that the guidelines be viewed as a call for increased research from industry and academia alike in the field of probiotics, and in no way as a dismissal of the category altogether.”

Key guideline recommendations

To summarize the guidelines, the AGA states:

-          For preterm (born before 37 weeks), low birthweight (< 2500 g) infants, specific probiotics can prevent mortality and necrotizing enterocolitis, reduce the number of days required to reach full feeds, and decrease the duration of hospitalization.
Specifically, AGA suggests using a combination of Lactobacillus ​spp. and Bifidobacterium ​spp. (L. rhamnosus ​ATCC 53103 and B. longum ​subsp. infantis​; or L. casei ​and B. breve​; or L. rhamnosus​, L. acidophilus​, L. casei​, B. longum ​subsp. infantis​, B. bifidum​, and B. longum ​subsp. longum​; or L. acidophilus ​and B. longum ​subsp. infantis​; or L. acidophilus ​and B. bifidum​; or L. 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.

-          Certain probiotics should be considered for the prevention of C. difficile infection in adults and children who take antibiotics.  
Specifically, AGA suggests for adults and children on antibiotic treatment, we 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 bifidum​; or the four-strain combination of L. acidophilus​, L. delbrueckii ​subsp. bulgaricus​, B. bifidum​, and Streptococcus salivarius ​subsp. thermophilus ​over no or other probiotics for prevention of C. difficile ​infection.

-          For the management of pouchitis in children and adults, a complication of ulcerative colitis that has been treated surgically, 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.

-          Probiotics do not appear to be beneficial for children in North America who have acute gastroenteritis - they should not be given routinely to children who present to the emergency room due to diarrhea.

-          There was insufficient evidence for AGA to make recommendations regarding the use of probiotics to treat C. difficile​ infection, Crohn's disease, ulcerative colitis or IBS. For these conditions, AGA suggests that patients consider stopping probiotics, as there are associated costs and not enough evidence to suggest lack of harm.

Source: Gastroenterology
Published online ahead of print, doi: 10.1053/j.gastro.2020.05.059c
“AGA Clinical Practice Guidelines on the Role of Probiotics in the Management of Gastrointestinal Disorders”
Authors: G.L. Su et al.

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