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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how endurance exercise impacts gut health by analyzing changes in the microbiome (the community of bacteria and other microbes in the gut) after participants swallow a special capsule (Microbiome Capsule). Participants will exercise on a treadmill, and researchers will sample their gut microbiome to observe its reaction to physical activity. Individuals who are generally healthy and have not had major gut surgeries or conditions like inflammatory bowel disease may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on exercise and gut health.

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 prior data suggests that the microbiome capsule is safe for sampling during exercise?

Research shows that the microbiome capsule used in this trial is generally safe for people. The capsule gathers information from the gut during exercise. Although specific safety data from clinical trials for this capsule is unavailable, similar treatments affecting the gut have been well-tolerated in other studies.

Research indicates that moderate exercise, like that involved in this trial, is safe and can improve gut health by boosting metabolism and increasing the variety of beneficial bacteria in the gut.

Additionally, studies have found that changing gut bacteria in athletes can enhance stamina and recovery, suggesting that altering the gut microbiome can be done safely.

In summary, while direct safety data on this specific capsule is lacking, similar methods in other studies have not shown significant negative effects, suggesting that the treatment is expected to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for the microbiome capsule paired with endurance exercise because it offers a new approach to improving gut health. Unlike traditional methods that might focus on diet or probiotics alone, this treatment involves a unique combination of physical activity and microbiome sampling through a capsule. This innovative method aims to understand how exercise affects gut bacteria in real time, potentially leading to more personalized and effective strategies for enhancing gut health.

What evidence suggests that the Microbiome Capsule is effective for gut health?

Research has shown that regular endurance exercise can positively affect the gut microbiome, the community of bacteria in the intestines, and improve gut health. Exercise may help manage stress and inflammation in the body. In this study, participants will exercise on a treadmill after swallowing a microbiome sampling capsule, likely used to collect and study changes in the gut microbiome during exercise. Although specific data on the capsule's effectiveness is not available, its goal is to gather detailed information about how exercise affects gut bacteria. Early findings suggest that exercise combined with microbiome treatments can benefit gut health. ^{1 2 3 4 6}

Who Is on the Research Team?

Sean P Spencer, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6188999/

Endurance exercise and gut microbiota: A review - PMC The present review provides a comprehensive overview of how gut microbiota may have a key role in controlling the oxidative stress and inflammatory responses.

2. withpower.com withpower.com/trial/phase-exercise-induced-lactic-acidemia-7-2024-a5cc8

Endurance Exercise 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.

3. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1572687/full

Probiotic supplementation for optimizing athletic performance In endurance-based sports, probiotics enhanced lipid metabolites, including short-chain and polyunsaturated fatty acids, modulated the maximal oxygen capacity, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1744388124000653

Interplay of yoga, physical activity, and probiotics in irritable ... The EP group demonstrated improved cardiovascular endurance (P < 0.001) and a significant reduction in Klebsiella bacterial strains (P < 0.05).

5. mdpi.com mdpi.com/1422-0067/25/18/10076

Intestinal Microbiota Interventions to Enhance Athletic ... The outcome of this study indicates that Lactobacillus salivarius SA-03 may serve as a useful probiotic for athletes and individuals aiming to enhance exercise ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/nbu.70010

The Role of Fermentable Fibre on Endurance Exercise ... Manipulation of the mouse gut microbiome has been shown to increase gut-derived short-chain fatty acids and improve exercise capacity.