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NCT04605783 · ClinicalTrials.gov registry record · NA
Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel
A NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- Completed
- Registry status
- NA
- Development phase
- 851
- Enrollment target
NCT04605783: Completed NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
NCT04605783 is a NA study that has completed, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 851 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04605783, a NA study, has completed, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 851 participants
- Enrollment target
Study Summary
Passive immunoprophylaxis is a class of dietary supplements that is lawfully marketed in the US for maintenance of gut health (GH). This randomized, double-blind, clinical trial will evaluate passive immunoprophylaxis (Travelan®) product compared with placebo, to assess the ability to maintain normal gut function during travel. The results of this clinical trial will be used to evaluate the use of a dietary supplement to maintain GH during deployment and travel and is not intended to support a marketing application of any dietary supplement as a drug or biological product for human use.
Primary Outcome
Combined endpoint of incidence of GH deficiencies (defined as 3 or more unformed stools in a 24-hour period) OR 2 or more unformed stools and one or more associated symptoms (nausea, vomiting, abdominal pain, fever, bloody stool) in a 24-hour period OR antibiotic treatment for diarrhea per subject report, during the period of prophylaxis.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Travelan®
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 851 participants |
| Start Date | 2022-05-27 |
| Est. Completion | 2025-06-20 |
| Phase | NA |
What the finished NCT04605783 record still lists
NCT04605783 is an interventional study that assigns participants to a tested intervention. The registered 851 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (39% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04605783 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04605783 about?
NCT04605783 is a clinical study titled "Trial to Evaluate Dietary Supplements to Maintain Gut Health During Travel". Passive immunoprophylaxis is a class of dietary supplements that is lawfully marketed in the US for maintenance of gut health (GH). This randomized, double-blind, clinical trial will evaluate passive immunoprophylaxis (Travelan®) product compared with placebo, to assess the ability to maintain norma...
What is the current status of trial NCT04605783?
This trial is currently completed. It is a NA study. The enrollment target is 851 participants. The study started on 2022-05-27. Estimated completion is 2025-06-20.
What interventions are being tested in trial NCT04605783?
The interventions under investigation include: Placebo (OTHER), Travelan® (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04605783?
This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04605783's enrollment target sits among peer trials
851 131st of 2000 higher than 1,870 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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