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

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

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)

Sponsors & Collaborators

• United States Army Combat Capabilities Development Command Soldier Center

  collaborator UNKNOWN

• United States Air Force Research Laboratory

  collaborator FED

• United States Army Research Institute of Environmental Medicine

  lead FED

Principal Investigators

• J. Philip Karl, PhD, RD · United States Army Research Institute of Environmental Medicine

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

17 Years

Max Age

39 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-06

Primary Completion

2025-10-28

Completion

2025-10-28

Countries

• United States

Study Locations