Endurance Exercise for Gut Health

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Gastrointestinal medications

Disqualifiers: Gastrointestinal surgery, Bowel obstruction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The small intestine and feces of subjects undergoing endurance exercise will be sampled to examine their microbiome composition

Will I have to stop taking my current medications?

The trial requires that you do not use any active medications for gastrointestinal conditions. If you are taking such medications, you would need to stop them to participate.

What data supports the effectiveness of the treatment Microbiome Capsule for gut health?

Research shows that regular exercise can positively change the gut microbiome, which is the community of bacteria in our intestines, and improve gut health. This suggests that treatments like the Microbiome Capsule, which aim to enhance gut health, might be more effective when combined with exercise. ^{1 2 3 4 5}

Is endurance exercise generally safe for gut health?

Research suggests that moderate physical activity is generally safe and can positively affect gut health by improving metabolism and microbial diversity. However, intense exercise may temporarily reduce microbial diversity, so it's important to balance exercise intensity. ^{3 6 7 8 9}

How does the Microbiome Capsule treatment differ from other treatments for gut health?

The Microbiome Capsule treatment is unique because it focuses on enhancing gut health through endurance exercise, which has been shown to rapidly and significantly alter the gut microbiome composition, increasing beneficial bacteria diversity. Unlike traditional treatments that may rely on diet or medication, this approach leverages physical activity as a powerful modulator of gut health. ^{7 10 11 12 13}

Research Team

Sean P Spencer, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for healthy men and women aged 18-70 who can understand English, agree to the study's terms, and are willing to use effective contraception if applicable. It excludes pregnant individuals, those planning pregnancy soon, people with health risks or substance abuse issues, unstable medical conditions that could affect the study, or a history of certain gastrointestinal surgeries or disorders.

Inclusion Criteria

ASA Classifications 1 and 2

For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit and willingness to use highly effective contraception

Subject is fluent in English, understands the study protocol and informed consent, and is willing and able to comply with study requirements and sign the informed consent form

Exclusion Criteria

Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding

A clinical condition that could potentially pose a health risk to the subject while involved in the study

Any form of active substance abuse or dependence, unstable medical or psychiatric disorder, or any chronic condition susceptible to interfere with the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Exercise and Sampling

Participants exercise on a treadmill after swallowing a microbiome sampling capsule, with controlled cooling to prevent increased body temperature

2 weeks

Multiple sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after exercise and sampling

4 weeks

Treatment Details

Interventions

• Microbiome Capsule

Trial Overview The trial is studying how endurance exercise affects the microbiome in the small intestine and feces by using cooling gloves during treadmill workouts. Participants will also take a microbiome capsule to aid in sampling their gut bacteria before and after exercise.

Participant Groups

Group I: Exercise with microbiome sampling Experimental Treatment 3 Interventions

Participants exercise on a treadmill after swallowing a microbiome sampling capsule. They will then repeat this procedure during controlled cooling of body temperature to prevent increased body temperature during exercise.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

Structured exercise programs lasting at least 12 weeks can lead to significant changes in the gut microbiome of patients with inflammatory bowel diseases (IBD), potentially improving their condition.

These exercise-induced changes may help regulate immunometabolic pathways, suggesting that personalized exercise regimens could serve as a valuable therapeutic addition for managing IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Role of exercise in preventing and restoring gut dysbiosis in patients with inflammatory bowel disease": A letter to the editor. Mc Gettigan, N., O'Toole, A., Boland, K.[2022]

Habitual physical activity is shown to be anti-inflammatory and may help prevent chronic inflammatory diseases, particularly by influencing gut health and the balance of gut microbiota.

Emerging research indicates that different types of exercise can affect the severity of intestinal inflammation, such as in conditions like ulcerative colitis, by impacting gut immune function and microbiome interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise and gut immune function: evidence of alterations in colon immune cell homeostasis and microbiome characteristics with exercise training. Cook, MD., Allen, JM., Pence, BD., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

"Role of exercise in preventing and restoring gut dysbiosis in patients with inflammatory bowel disease": A letter to the editor. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Exercise Prescription on the Human Gut Microbiota and Comparison between Clinical and Apparently Healthy Populations: A Systematic Review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Assessing the relationship between physical activity and the gut microbiome in a large, population-based sample of Wisconsin adults. [2022]

4. France pubmed.ncbi.nlm.nih.gov

The Association between Objectively Measured Physical Activity and the Gut Microbiome among Older Community Dwelling Men. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Moderate Exercise Has Limited but Distinguishable Effects on the Mouse Microbiome. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Ultra-Endurance triathlon competition shifts fecal metabolome independent of changes to microbiome composition. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Essential Factors for a Healthy Microbiome: A Scoping Review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Gut check: Unveiling the influence of acute exercise on the gut microbiota. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Voluntary and forced exercise differentially alters the gut microbiome in C57BL/6J mice. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Rapid gut microbiome changes in a world-class ultramarathon runner. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Attributes of Physical Activity and Gut Microbiome in Adults: A Systematic Review. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Exercise and gut immune function: evidence of alterations in colon immune cell homeostasis and microbiome characteristics with exercise training. [2018]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Mutual Interactions among Exercise, Sport Supplements and Microbiota. [2020]