Microbiome Sampling During Endurance Exercise

Not Applicable

Recruiting

• Conditions: Healthy; Exercise-Induced Lactic Acidemia

• Registration Number: NCT06903806
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed Description

The close relationship between humans and the commensal microbes of their gut microbiota represents vast potential for health maintenance, but most efforts have been focused on disease. Gastrointestinal (GI) problems are very common especially in endurance athletes, and are known to impair performance or subsequent recovery. Moreover, GI symptoms among athletes vary enormously, and some athletes are more prone than others; the links between this variation and the differences in microbiome composition across individuals have not been elucidated. The investigators propose to use a novel, non-invasive sampling technology to quantify the effects of exercise on the GI environment including the small intestines, and aim to establish the potential for dietary interventions to improve recovery from exercise.

Study Timeline

• Study Start: 2024-08-04
• Status Verified: 2025-03
• Study First Submitted: 2025-03-25
• Study First Submitted QC: 2025-03-25
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-04-01
• Last Update Posted: 2025-04-01
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of participants completing exercise	1 day	Target goal is 80% of subjects will complete their exercise testing

Secondary Outcome Measures

Name	Time	Method
Volume of intestinal fluid from subjects for analysis	2 weeks	Target goal is 80% of subjects to have at least 100ul of intestinal fluid collected from microbiome-sampling capsule

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States