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NCT05392556 · ClinicalTrials.gov registry record · NA
Prebiotic and Probiotic Modulation of the Gut Microbiota-gut-brain Axis During Acute Stress
A NA study, sponsored by United States Army Research Institute of Environmental Medicine.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
NCT05392556: Completed NA study, sponsored by United States Army Research Institute of Environmental Medicine.
NCT05392556 is a NA study that has completed, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 73 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05392556, a NA study, has completed, sponsored by United States Army Research Institute of Environmental Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
Study Summary
Emerging evidence supports the existence of a microbiota-gut-brain axis through which gut microbes influence cognition, mood and behavior. Targeting this axis with probiotics and/or prebiotics may provide novel strategies for mitigating stress-induced decrements in gastrointestinal and cognitive function. This double-blind, placebo-controlled, randomized, parallel-arm trial will determine the effects of a prebiotic and a probiotic dietary intervention on gastrointestinal, cognitive and physiologic responses to acute military-relevant physical and cognitive stress. Healthy men and women will be recruited and randomized to receive a placebo, probiotic or prebiotic for 4wk. Volunteers will be fed a controlled diet during the 4th week of supplementation. Fecal, blood, urine and saliva samples will be collected. Physical stress will be induced by a weighted walk on a treadmill, and will be followed by a cognitively challenging testing scenario that uses intermittent electric shocks to the abdomen to induce a stress response.
Primary Outcome
A differential sugar absorption test will be used to assess intestinal permeability. Participants will consume 2g sucralose and 4g mannitol dissolved in 180 mL water prior to starting exercise. Participants will then collect all urine produced over the subsequent 4hr. Urine sucralose and mannitol concentrations will be analyzed.
Interventions
- OTHER Placebo
- DIETARY_SUPPLEMENT Probiotic
- DIETARY_SUPPLEMENT Prebiotic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2022-07-06 |
| Est. Completion | 2025-10-28 |
| Phase | NA |
What the finished NCT05392556 record still lists
NCT05392556 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05392556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05392556 about?
NCT05392556 is a clinical study titled "Prebiotic and Probiotic Modulation of the Gut Microbiota-gut-brain Axis During Acute Stress". Emerging evidence supports the existence of a microbiota-gut-brain axis through which gut microbes influence cognition, mood and behavior. Targeting this axis with probiotics and/or prebiotics may provide novel strategies for mitigating stress-induced decrements in gastrointestinal and cognitive fun...
What is the current status of trial NCT05392556?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2022-07-06. Estimated completion is 2025-10-28.
What interventions are being tested in trial NCT05392556?
The interventions under investigation include: Placebo (OTHER), Probiotic (DIETARY_SUPPLEMENT), Prebiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05392556?
This trial is sponsored by United States Army Research Institute of Environmental Medicine, which has 59 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05392556's enrollment target sits among peer trials
73 1089th of 2000 higher than 912 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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