Status:
RECRUITING
Microbiome Sampling During Endurance Exercise
Lead Sponsor:
Stanford University
Conditions:
Healthy
Exercise-Induced Lactic Acidemia
Eligibility:
All Genders
18-80 years
Phase:
NA
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. Gastrointestin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06903806
Start Date
August 4 2024
End Date
December 1 2026
Last Update
April 1 2025
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305