Examining gut microbiome changes during endurance exercise

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Stanford University
  Stanford, California, United States Recruiting

Study contacts

• Principal investigator: Sean P Spencer, MD, PhD — Stanford University

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.