Recruiting

Microbiome Sampling

Sponsor:

Stanford University

Code:

NCT06903806

Conditions

Healthy

Exercise-Induced Lactic Acidemia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Treadmill Exercise

Cooling Gloves

Microbiome Capsule

Study Details

Brief summary:

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

Conditions

Healthy

Exercise-Induced Lactic Acidemia

Study ID

NCT06903806

Start date

Aug 4, 2024

Status verified date

Mar, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Exercise with microbiome sampling

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.

Interventions

Treadmill Exercise

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

Cooling Gloves

Cooling gloves to prevent rise in core body temperature during exercise

Microbiome Capsule

Capsule used for collecting intestinal tract contents

Primary outcome measure

  • Number of participants completing exercise [ Time Frame: 1 day ]

Central Contacts and Locations

Locations

Stanford University

Recruiting

Stanford, California, United States, 94305

Contacts

Sean P Spencer, MD/PhD

650-736-5555seanspen@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Apr 1, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-04-01.