Prebiotics + Probiotics for Stress

Overseen By J. Philip Karl, PhD, RD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: United States Army Research Institute of Environmental Medicine

Must not be taking: Antibiotics, Antimycotics, Prescription medications

Disqualifiers: Pregnancy, Neurological disorders, Cardiac disease, GI tract disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether prebiotics and probiotics can reduce stress effects on the gut and mind. The researchers aim to determine if these supplements improve gut health and mental sharpness under stress. Participants will be divided into groups to receive either a placebo, a probiotic (beneficial bacteria), or a prebiotic (oligofructose-enriched inulin) for four weeks. Healthy, physically active individuals who can handle a treadmill walk with a weighted vest and manage stress might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to the scientific understanding of gut and mental health.

Will I have to stop taking my current medications?

You may need to stop taking some medications, as regular use of over-the-counter medications and prescription medications (other than contraceptives) requires approval. You also need to stop using dietary supplements and probiotic-containing foods at least 2 weeks before and during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that prebiotics like Bimuno-galactooligosaccharide (Bimuno-GOS) are generally safe. Studies have found that inulin-type oligosaccharides, a type of prebiotic, are safe to consume. They are non-toxic and often used in dietary supplements. Most people tolerate them well, though some might experience mild digestive issues.

Research also indicates that probiotics, including strains like Bifidobacterium longum and Lactobacillus helveticus, are usually safe for most individuals. These probiotics are live bacteria that support gut health. However, in rare cases, they might cause infections, particularly in those with weakened immune systems.

In summary, both prebiotics and probiotics in this trial are generally well-tolerated and considered safe for healthy individuals. However, as with any supplement, some might experience minor side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer a natural approach to managing stress. Unlike traditional options that may focus on medications or therapy, the prebiotic Bimuno-GOS and probiotics Bifidobacterium longum R0175 and Lactobacillus helveticus R0052 aim to support mental well-being by enhancing gut health. This approach taps into the gut-brain axis, suggesting that a healthier gut can lead to reduced stress levels. Such treatments present a novel way to address stress by potentially balancing the body's microbiome, which is different from standard treatments that don't typically involve gut health.

What evidence suggests that this trial's treatments could be effective for stress?

This trial will compare the effects of prebiotics and probiotics on stress. Research has shown that certain prebiotics, such as galacto-oligosaccharides (GOS), can help reduce anxiety. In one study, British female students who took GOS supplements felt less anxious. Another study found that prebiotics might also boost mood in healthy individuals. Participants in this trial may receive a prebiotic treatment to evaluate its effects on stress.

For probiotics, research has found that a mix of Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 can help with stress and anxiety. These probiotics improve gut health and reduce inflammation, suggesting they might help manage stress by supporting a healthy connection between the gut and the brain. Participants in this trial may receive a probiotic treatment to assess its impact on stress. ^{6 7 8 9 10}

Who Is on the Research Team?

J. Philip Karl, PhD, RD

Principal Investigator

United States Army Research Institute of Environmental Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have 4 or more bowel movements each week.

In good health as determined by Medical Clearance

Self-reports normal hearing

Exclusion Criteria

Cardiac disease (including arrhythmia or fast or skipped heart beats), Hypertension, Has a pacemaker, Insomnia, Musculoskeletal injuries that compromise exercise capability, Metabolic or cardiovascular abnormalities (e.g., kidney disease, diabetes, etc.), Disease of the GI tract including, but not limited to diverticulitis, inflammatory bowel disease, irritable bowel syndrome, peptic ulcer disease, Crohn's disease, and ulcerative colitis, Excessive alcohol use or other substance abuse issues, Immunodeficiency disorder, Allergy to skin adhesive

Colonoscopy within 3 months of study participation

Following vegetarian/vegan diet or other highly restrictive diet (e.g., ketogenic diet, very high protein diet, Paleo diet)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a placebo, probiotic, or prebiotic for 4 weeks, with a controlled diet during the 4th week. Samples are collected, and stress is induced through physical and cognitive challenges.

4 weeks

Weekly visits for sample collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Prebiotic
• Probiotic

Trial Overview 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.

How Is the Trial Designed?

Group I: Probiotic Experimental Treatment 1 Intervention

Bifidobacterium longum R0175; Lactobacillus helveticus R0052 (Cerebiome; Lallemand Health Solutions)

Group II: Prebiotic Experimental Treatment 1 Intervention

Bimuno-galactooligosaccharide (Bimuno-GOS; Clasado Biosciences)

Group III: Placebo Placebo Group 1 Intervention

Maltodextrin placebo

Who Is Running the Clinical Trial?

United States Army Research Institute of Environmental Medicine

Lead Sponsor

Trials

67

Recruited

3,700+

United States Air Force Research Laboratory

Collaborator

Trials

1

Recruited

50+

United States Army Combat Capabilities Development Command Soldier Center

Collaborator

Trials

1

Recruited

50+

United States Air Force Research Laboratory

Collaborator

Trials

3

Recruited

310+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S175646462400358X

Prebiotic effect of oligofructose after 2 weeks ... This study is the first to demonstrate a significant increase in bifidobacteria coinciding with increased stool frequency after a very low dose of 2.5 g/d ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05372601

NCT05372601 | Prebiotics and Stress Reduction in Women Recent research found that supplementation of galactose-oligosaccharides (GOS) resulted in reduced anxiety levels in British female students with higher anxiety ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8050281/

Anxiolytic effects of a galacto-oligosaccharides prebiotic in ... A study in adult volunteers found that the consumption of probiotics in a randomised double-blind trial reduced measures of low mood and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11665422/

A prebiotic intervention improves mood in everyday life in ... Prebiotic dietary fiber (PDF) may reduce feelings of stress or improve mood in healthy individuals. Yet gut intervention studies that focus ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022316623111035

Prebiotic Consumption Alters Microbiota but Not Biological ... FOS+GOS did not affect biological markers of stress and inflammation or mental health symptoms in healthy adults; however, it increased Bifidobacterium.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4729356/

A Combination of Prebiotic Inulin and Oligofructose ... Conclusion: Oligofructose-enriched inulin may improve glycemic indices, lipid profile, antioxidant status and malondialdehyd in women with type 2 diabetes.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0278691508003761

Safety evaluation of oligofructose: 13 Week rat study and in ... Inulin is a non-toxic food ingredient with generally recognized as safe (GRAS), whose health benefits exceeds that of just dietary fiber (laxation and ...

8. webmd.com webmd.com/vitamins/ai/ingredientmono-1048/inulin

Inulin - Uses, Side Effects, and More It is possibly safe in adults when taken as a supplement, short-term. Doses of 8-18 grams daily have been used safely for up to 24 weeks. The most common side ...

9. mdpi.com mdpi.com/2072-6643/13/4/1276

Long-Term Safety and Efficacy of Prebiotic Enriched Infant ... The present study aims to evaluate the effects of an infant formula supplemented with a mixture of prebiotic short and long chain inulin-type oligosaccharides ...

10. nutraingredients.com nutraingredients.com/Article/2008/11/03/Prebiotic-oligofructose-passes-safety-test-study/

Prebiotic oligofructose passes safety test: study Consumption of the prebiotic fibre oligofructose at a dietary level of almost 10 per cent is safe, according to a new Anglo-American study.