CompletedEarly Phase 1

Mechanisms of Probiotics and Antibiotic-Associated Diarrhea

United States118 participantsStarted 2021-01-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Has the ability to read, speak, and write in English * Has a refrigerator (for proper storage of the study yogurt) * Has reliable telephone access * Is between ages of 18-65 years * Agree to refrain from eating yogurts, yogurt drinks, and other foods specified in the provided list * Agree to collect stool samples and participate in follow-up calls as specified Exclusion Criteria: * Diabetes or asthma that requires medication * Allergy to strawberry * Active diarrhea (three or more loose stools per day for two consecutive days) * Any gastrointestinal (or digestive tract) medications, i.e. medicines for irritable bowel syndrome, gastroesophageal (acid) reflux disease, inflammatory bowel disease, etc. * History of heart disease, including valvulopathies or cardiac surgery, any implantable device or prosthetic * History of gastrointestinal surgery or disease * Lactose intolerance that prevents participant from eating yogurt * Allergy to milk-protein * Allergy to any component of the product or the yogurt vehicle * Allergy to penicillin or cephalosporin class antibiotics * Allergy to any of the following medications: a) Penicillin; b) Erythromycin; c) Tetracycline; d) Trimethoprim; e) Ciprofloxacin * Women who are breastfeeding, pregnant, or planning to become pregnant during the study * Was a participant in the "YOBIOTIC" study

What they're measuring

Change From Baseline Levels of Fecal Short-chain Fatty Acid (With a Particular Focus on Acetate)

Timeframe: day 7

Change From Baseline Levels of Fecal Short-chain Fatty Acid (With a Particular Focus on Acetate)

Timeframe: day 30

Trial details

NCT IDNCT04414722

SponsorGeorgetown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-05-01

Results submitted2024-11-21