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Recruiting

NCT Number: NCT06903806

Microbiome Sampling During Endurance Exercise

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

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Location status: Recruiting

Location contact

Sean P Spencer, MD/PhD

CONTACT

[email protected]

650-736-5555

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill Exercise

Other

Participants perform moderate to strenuous exercise for up to 20 minutes on a treadmill after swallowing a microbiome sampling capsule.

Cooling Gloves

Device

Cooling gloves to prevent rise in core body temperature during exercise

Microbiome Capsule

Device

Capsule used for collecting intestinal tract contents

Primary outcomes

  1. Number of participants completing exercise

    Time frame: 1 day

    Target goal is 80% of subjects will complete their exercise testing

Secondary outcomes

  1. Volume of intestinal fluid from subjects for analysis

    Time frame: 2 weeks

    Target goal is 80% of subjects to have at least 100ul of intestinal fluid collected from microbiome-sampling capsule

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Determination of Microbiome Diversity and Inflammation Throughout the GI Tract During Endurance Exercise

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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