CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 118 enrolled
Drug / intervention
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet +2 moredrug
Likely dose
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04414722
NCT04414722Early Ph 1Completed

Exploratory Pilot Studies to Demonstrate Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics

Georgetown University·interventional·Posted Jun 4, 2020·Updated Feb 25, 2025

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
202120222023202420252026
First PostedJun 4, 2020
Enrollment StartJan 1, 2021
Primary CompletionMay 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 6.1 years ago

Interventions

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tabletdrug

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

BB-12biological

Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt

Control Yogurtother

Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)