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NCT04414722 · ClinicalTrials.gov registry record · Early Phase 1
Mechanisms of Probiotics and Antibiotic-Associated Diarrhea
A Early Phase 1 study, sponsored by Georgetown University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 118
- Enrollment target
NCT04414722: Completed Early Phase 1 study, sponsored by Georgetown University.
NCT04414722 is a Early Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 118 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04414722, a Early Phase 1 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 118 participants
- Enrollment target
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
Change from baseline levels of fecal short-chain fatty acid (with a particular focus on acetate)
Interventions
- DRUG Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
- BIOLOGICAL BB-12
- OTHER Control Yogurt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2023-05-01 |
| Phase | Early Phase 1 |
What the finished NCT04414722 record still lists
NCT04414722 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 3 interventions - of which Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet is the first listed.
NCT04414722 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04414722 about?
NCT04414722 is a clinical study titled "Mechanisms of Probiotics and Antibiotic-Associated Diarrhea". 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 NCT04414722?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 118 participants. The study started on 2021-01-01. Estimated completion is 2023-05-01.
What interventions are being tested in trial NCT04414722?
The interventions under investigation include: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet (DRUG), BB-12 (BIOLOGICAL), Control Yogurt (OTHER).
Who is sponsoring clinical trial NCT04414722?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04414722's enrollment target sits among peer trials
118 158th of 2000 higher than 1,843 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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