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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 is a NA study that has completed, run by United States Army Research Institute of Environmental Medicine. The registered enrollment target is 73 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05392556
The ClinicalTrials.gov registry entry for NCT05392556 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 73 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is United States Army Research Institute of Environmental Medicine, which has 59 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05392556 reports 0 study locations.
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.
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