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NCT03755765 · ClinicalTrials.gov registry record · Early Phase 1
Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics
A Early Phase 1 study of Antibiotic-associated Diarrhea, sponsored by Georgetown University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT03755765: Completed Early Phase 1 study of Antibiotic-associated Diarrhea, sponsored by Georgetown University.
NCT03755765 is a Early Phase 1 study of Antibiotic-associated Diarrhea that has completed, run by Georgetown University. The registered enrollment target is 66 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03755765, a Early Phase 1 study of Antibiotic-associated Diarrhea, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Level of fecal short-chain fatty acid acetate (SCFA) after administration of amoxicillin clavulanate
Conditions Studied
Interventions
- OTHER Control
- DRUG Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
- BIOLOGICAL BB-12
Study Locations (1)
District of Columbia
- Georgetown University Department of Family Medicine - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2019-07-23 |
| Est. Completion | 2020-01-08 |
| Phase | Early Phase 1 |
What the finished NCT03755765 record still lists
NCT03755765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (25% higher).
The record links to 1 condition, with Antibiotic-associated Diarrhea appearing as the primary indexed condition, and to 3 interventions - of which Control is the first listed.
NCT03755765 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT03755765 about?
NCT03755765 is a clinical study titled "Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics". 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. C...
What is the current status of trial NCT03755765?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 66 participants. The study started on 2019-07-23. Estimated completion is 2020-01-08.
What conditions does trial NCT03755765 study?
This clinical trial studies the following conditions: Antibiotic-associated Diarrhea.
What interventions are being tested in trial NCT03755765?
The interventions under investigation include: Control (OTHER), Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet (DRUG), BB-12 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03755765?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03755765 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03755765's enrollment target sits among peer trials
66 363rd of 2000 higher than 1,630 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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