Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics (NCT03755765) | Clinical Trial Compass
CompletedEarly Phase 1
Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics
United States66 participantsStarted 2019-07-23
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 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 What Not to Eat 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.
What they're measuring
1
Level of Fecal Short-chain Fatty Acid (SCFA) Acetate