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COMPLETED Early Phase 1

Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics

NCT03755765 · View on ClinicalTrials.gov ↗

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

  • 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

FieldValue
Enrollment Target 66 participants
Start Date 2019-07-23
Est. Completion 2020-01-08
Phase Early Phase 1

Sponsor

Georgetown University

109 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03755765

The ClinicalTrials.gov registry entry for NCT03755765 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 109 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03755765 reports 1 study location spanning 1 distinct geographic area — top geographies include District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03755765?

This trial is sponsored by Georgetown University, which has 109 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial