RECRUITING

Microbiome Sampling During Endurance Exercise

Conditions

Healthy Exercise-Induced Lactic Acidemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-08-04

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06903806

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* 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

Inclusion Criteria

Exclusion Criteria

* 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.

* 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

Contacts and Locations

Principal Investigator

Sean P Spencer, MD, PhD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford University

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

Sean P Spencer, MD, PhD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-04

Study Completion Date2026-12

Study Record Updates

Study Start Date2024-08-04

Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

Healthy
Exercise-Induced Lactic Acidemia