- “Probiotics” are defined by the Food and Agriculture Organization of the United Nations and the World Health Organization as “live microorganisms which when administered in adequate amounts confer a health benefit on the host.”
- “Prebiotics” are nutrients which promote growth or beneficial functions of beneficial microbes.
- It is estimated that in 2015 3.9 million American adults used some form of probiotics or prebiotics.
- The industry is largely unregulated, allowing widespread use and often biased information.
- Clinical studies, mostly with small numbers of patients, have been extremely varied including differences in the strain(s), dose, and route of administration of microbe(s) used, the research methodology and the reporting of endpoints and outcomes.
- This study prioritized Clostridioides difficile-associated diseases, inflammatory bowel disease, irritable bowel syndrome, infectious gastroenteritis, and necrotizing enterocolitis and is focused on patient-important outcomes.
|Recommendation Statements||Strength of Recommendation||Certainty of Evidence|
|1. In patients with C. difficile infection, AGA recommends the use of probiotics only in the context of a clinical trial.||No recommendation||Knowledge gap|
|2. In adults and children on antibiotic treatment, AGA suggests the use of S. boulardii; or the two-strain combination of L. acidophilus CL1285 and L. casei LBC80R; or the three-strain combination of L. acidophilus, L. delbrueckii subsp. bulgaricus, and B. bifidum; or the four-strain combination of L. acidophilus, L. delbrueckii subsp. bulgaricus, B. bifidum, and S. salivarius subsp. thermophilus over no or other probiotics for prevention of C. difficile infection.|
Comment: Patients who place a high value on the potential harms (particularly those with severe illnesses) or a high value on avoiding the associated cost and a low value on the small risk of C. difficile development (particularly in the outpatient setting) would reasonably select no probiotics.
|3. In adults and children with Crohn’s disease, AGA recommends the use of probiotics only in the context of a clinical trial.||No recommendation||Knowledge gap|
|4. In adults and children with ulcerative colitis, AGA recommends the use of probiotics only in the context of a clinical trial.||No recommendation||Knowledge gap|
|5. In adults and children with pouchitis, AGA suggests 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.|
Comment: Patients for whom the feasibility and cost of using this combination of bacterial strain is problematic may reasonably select no probiotics.
|6. In symptomatic children and adults with irritable bowel syndrome, AGA recommends the use of probiotics only in the context of a clinical trial.||No recommendation||Knowledge gap|
|7. In children with acute infectious gastroenteritis, we suggest against the use of probiotics.||Conditional||Moderate|
|8. In preterm (less than 37 weeks GA), low birth weight infants, 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. longu 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) for prevention of NEC over no and other probiotics.||Conditional||Moderate/high|
GRADE Strength of Recommendations and Implications
|Grade||Quality of Evidence|
|High||We are very confident that the true effect lies close to that of the estimate of the effect.|
|Moderate||We are moderately confident in the effect estimate. The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.|
|Low||Our confidence in the effect estimate is limited. The true effect may be substantially different from the estimate of the effect.|
|Very Low||We have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect.|
|Grade||Strength of Recommendation|
|Strong||For the Patient||For the Clinician||For policymakers|
|Most individuals in this situation would want the recommended course of action and only a small proportion would not.||Most individuals should receive the recommended course of action. Formal decision aids are not likely to be needed to help individuals make decisions consistent with their values and preferences.||The recommendation can be adapted as policy or performance measure in most situations.|
|Conditional (weak)||The majority of individuals in this situation would want the suggested course of action, but many would not.||Different choices will be appropriate for different patients. Decision aids may be useful in helping individuals in making decisions consistent with their values and preferences. Clinicians should expect to spend more time with patients when working towards a decision.||Policy-making will require substantial debate and involvement of various stakeholders. Performance measures should assess whether decision making is appropriate.|