drugset / Trial / NCT04414722

Mechanisms of Probiotics and Antibiotic-Associated Diarrhea

NCT04414722

RandomizedParallel-groupTriple-blindOther

Summary

The focus of the study is to better understand the mechanisms causing antibiotic-associated diarrhea (AAD) and how probiotics may prevent some of the iatrogenic effects of antibiotic medications. One of the most common indications for probiotics is for prevention of antibiotic-associated diarrhea. Clinically, different probiotic strains have demonstrated the ability to prevent AAD; however, the mechanism of action behind this effect has not been elucidated. Data from several studies suggest that antibiotic-induced disruption of commensal bacteria in the colon results in a significant (up to 50%) reduction in short chain fatty acid (SCFA) production and a concomitant reduction in Na-dependent fluid absorption resulting in AAD. Probiotics have been shown to ameliorate a variety of gastrointestinal disease states and thus, the study investigators hypothesize that administration of a probiotic yogurt will protect against the development of AAD.

Timeline

Start
2021-01-01
Primary completion
2023-05-01
Completion
2023-05-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator BB-12 Unknown Oral
Background Amoxicillin Other / unclassified 125 mg Oral
Background Amoxicillin Other / unclassified 875 mg Oral

Indications