Examining gut microbiome changes during endurance exercise
Determination of Microbiome Diversity and Inflammation Throughout the GI Tract During Endurance Exercise
NA · Stanford University · NCT06903806
This study looks at how endurance exercise affects the gut bacteria of healthy adults aged 18 to 70 and whether changes in diet can help improve recovery from exercise-related stomach issues.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT06903806 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between endurance exercise and the gut microbiome by sampling the small intestine and feces of participants. It aims to understand how exercise affects gastrointestinal health, particularly in endurance athletes who often experience GI issues. Using a novel, non-invasive sampling technology, the study will quantify microbiome changes and explore the potential for dietary interventions to enhance recovery from exercise. The research focuses on healthy individuals aged 18 to 70, assessing the microbiome's role in exercise-induced lactic acidosis.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 70 who are fluent in English and can comply with study requirements.
Not a fit: Patients with significant gastrointestinal disorders or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary strategies for athletes to enhance recovery and performance.
How similar studies have performed: While studies on the microbiome and exercise are emerging, this specific approach using non-invasive sampling technology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects must meet all of the following criteria to be included in the study: * Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit. * ASA Classifications 1 and 2. * For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence). * Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form. Non-English speakers will not be included in the study because consent forms are in English, and any instructions during exercise will need to be provided in English. Exclusion Criteria: Subjects with any of the following conditions or characteristics must be excluded from the study: * History of any of the following: * Prior gastric or esophageal surgery, including lap banding or bariatric surgery * Bowel obstruction * Gastric outlet obstruction * Diverticulitis * Inflammatory bowel disease * Ileostomy or colostomy * Gastric or esophageal cancer * Achalasia * Esophageal diverticulum * Active Dysphagia or Odynophagia * Active medication use for any gastrointestinal conditions * Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding * Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study * A clinical condition that, in the judgment of the investigator, could potentially pose a health risk to the subject while involved in the study
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (RECRUITING)
Study contacts
- Principal investigator: Sean P Spencer, MD, PhD — Stanford University
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Healthy, Exercise-Induced Lactic Acidemia