NCT05392556

Prebiotic and Probiotic Modulation of the Gut Microbiota-gut-brain Axis During Acute Stress

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: United States Army Research Institute of Environmental Medicine · Federal
• Sex: All
• Age: 17 Years – 39 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stress Physiology

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Cerebiome (Lallemand Health Solutions): probiotic supplement containing Bifidobacterium longum R0175, Lactobacillus helveticus R0052, and maltodextrin. Dosing: Oral, 3.6 g/d containing 3x10\^9 CFU/d (powder form)
DIETARY_SUPPLEMENT	Prebiotic	Bimuno-GOS (Clasado Biosciences): Dosing: Oral; 3.6 g/d containing 2.75 g active GOS/d (powder form)
OTHER	Placebo	Maltodextrin 3.6 g/d (powder form)

Timeline

• Start date: 2022-07-06
• Primary completion: 2025-10-28
• Completion: 2025-10-28
• First posted: 2022-05-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: United States