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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 is a Early Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 118 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04414722
The ClinicalTrials.gov registry entry for NCT04414722 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 118 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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