← Back to Search

Prebiotic

Prebiotics + Probiotics for Stress

N/A
Recruiting
Led By J. Philip Karl, PhD, RD
Research Sponsored by United States Army Research Institute of Environmental Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-reports ≥4 bowel movements/week
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before (-45min) exercise, after 40 and 100 min of exercise, and immediately after exercise on days 0 and 29
Awards & highlights

Study Summary

This trial will determine the effects of a prebiotic and probiotic dietary intervention on responses to physical and cognitive stress.

Who is the study for?
Healthy men and women aged 18-39, meeting Army body standards or exercising ≥4 days/week. Must have normal hearing, regular bowel movements, not pregnant/breastfeeding, no recent antibiotics or IUD changes, no excessive alcohol/substance use, no immunodeficiency disorders or allergies to adhesives. Cannot be on certain medications or diets that could affect the study.Check my eligibility
What is being tested?
The trial is testing how a prebiotic and a probiotic can influence stress responses compared to a placebo. Participants will undergo physical and cognitive stress tests after taking their assigned supplement for four weeks while maintaining a controlled diet in the last week.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort such as bloating or gas due to prebiotics/probiotics adjusting gut bacteria balance. Other mild reactions might occur from consuming unfamiliar supplements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have 4 or more bowel movements each week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before (-45min) exercise, after 40 and 100 min of exercise, and immediately after exercise on days 0 and 29.
This trial's timeline: 3 weeks for screening, Varies for treatment, and before (-45min) exercise, after 40 and 100 min of exercise, and immediately after exercise on days 0 and 29. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in intestinal permeability
Hydrocortisone
Secondary outcome measures
Change from baseline in mean heart rate variability
Change from baseline in performance on decision making under conditions of ambiguity task
Change from baseline in salivary secretory immunoglobulin A
+25 more
Other outcome measures
Change from baseline in aggression
Change from baseline in exercise energy expenditure
Change from baseline in mean heart rate
+16 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: ProbioticExperimental Treatment1 Intervention
Bifidobacterium longum R0175; Lactobacillus helveticus R0052 (Cerebiome; Lallemand Health Solutions)
Group II: PrebioticExperimental Treatment1 Intervention
Bimuno-galactooligosaccharide (Bimuno-GOS; Clasado Biosciences)
Group III: PlaceboPlacebo Group1 Intervention
Maltodextrin placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Probiotic
2013
Completed Phase 4
~3570
Prebiotic
2016
Completed Phase 2
~720

Find a Location

Who is running the clinical trial?

United States Air Force Research LaboratoryUNKNOWN
1 Previous Clinical Trials
106 Total Patients Enrolled
United States Army Research Institute of Environmental MedicineLead Sponsor
59 Previous Clinical Trials
3,376 Total Patients Enrolled
United States Army Combat Capabilities Development Command Soldier CenterUNKNOWN

Media Library

Prebiotic (Prebiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05392556 — N/A
Stress Physiology Research Study Groups: Placebo, Probiotic, Prebiotic
Stress Physiology Clinical Trial 2023: Prebiotic Highlights & Side Effects. Trial Name: NCT05392556 — N/A
Prebiotic (Prebiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05392556 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the target number of participants for this research project?

"The most recent update on clinicaltrials.gov says that this trial is still looking for patients. This trial was posted on 6/1/2022 and the 54 participants must come from 1 site."

Answered by AI

Who would fit the profile of an ideal candidate for this clinical trial?

"The ideal candidate for this study of stress physiology would be between the ages of 17 and 39. Currently, the trial has 54 slots open for participants."

Answered by AI

Could minors participate in this clinical trial if they met the other requirements?

"The age requirement to participate in this clinical trial is 17-39. If a patient does not meet this age criterion, they can look into the 1 trial for those under 18 or the 1 for people 65 and older."

Answered by AI

What is the main goal of this research?

"The primary goal of this study, which will monitor patients before, during, and after exercise as well as before and after exposure to cognitive stress on days 0 and 29, is to change the baseline of intestinal permeability. Additionally, researchers are looking at the difference from the baseline in mood state (as measured by the POMS2A scale) , response inhibition (using a go/no-go task), and feelings of arousal (Felt Arousal Scale)."

Answered by AI

Are we still able to enroll new volunteers for this research project?

"That is correct, according to the information available on clinicaltrials.gov this trial posted on June 1st, 2022 is still recruiting patients. The study aims to recruit 54 people from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Prebiotic and Probiotic Modulation of the Gut Microbiota-gut-brain Axis During Acute Stress
2022. "Prebiotic and Probiotic Modulation of the Gut Microbiota-gut-brain Axis During Acute Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05392556.
~9 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top