At a glance
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Exploratory Pilot Studies to Demonstrate Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics
In Brief
A Early Phase 1 clinical trial evaluating Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet, BB-12, and 1 other intervention for Antibiotic-associated Diarrhea. Completed, enrolled 118 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)