Microbiome Sampling During Endurance Exercise

NCT06903806 | Recruiting

• 1 other identifier: IRB-67010
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Number of participants completing exercise

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

  1 day

Secondary Outcomes (1)

• Volume of intestinal fluid from subjects for analysis

  2 weeks

Study Arms (1)

Exercise with microbiome sampling

EXPERIMENTAL

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.

Other: Treadmill Exercise; Device: Cooling Gloves; Device: Microbiome Capsule

Interventions

Treadmill Exercise OTHER

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

Exercise with microbiome sampling

Cooling Gloves DEVICE

Cooling gloves to prevent rise in core body temperature during exercise

Exercise with microbiome sampling

Microbiome Capsule DEVICE

Capsule used for collecting intestinal tract contents

Exercise with microbiome sampling

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

Related Publications (1)

• Shalon D, Culver RN, Grembi JA, Folz J, Treit PV, Shi H, Rosenberger FA, Dethlefsen L, Meng X, Yaffe E, Aranda-Diaz A, Geyer PE, Mueller-Reif JB, Spencer S, Patterson AD, Triadafilopoulos G, Holmes SP, Mann M, Fiehn O, Relman DA, Huang KC. Profiling the human intestinal environment under physiological conditions. Nature. 2023 May;617(7961):581-591. doi: 10.1038/s41586-023-05989-7. Epub 2023 May 10.

  PMID: 37165188 BACKGROUND

Study Officials

• Sean P Spencer, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine, Gastroenterology and Hepatology

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 1, 2025
• Study Start: August 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)