HealthyNCT06903806
Microbiome Sampling During Endurance Exercise
A study testing Treadmill Exercise, Cooling Gloves and Microbiome Capsule in people with Healthy and Exercise-Induced Lactic Acidemia, run by Stanford University at 1 site in United States.
Trial summary
The small intestine and feces of subjects undergoing endurance exercise will be sampled to examine their microbiome composition Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Exercise-Induced Lactic Acidemia
- What is being tested?
- Treadmill Exercise, Cooling Gloves and Microbiome Capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94305
Sean P Spencer, MD/PhD, 650-736-5555, seanspen@stanford.edu
About this study
Official title: Determination of Microbiome Diversity and Inflammation Throughout the GI Tract During Endurance Exercise
The small intestine and feces of subjects undergoing endurance exercise will be sampled to examine their microbiome composition
Read the 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. 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.
- Conditions
- Healthy, Exercise-Induced Lactic Acidemia
- Being tested
- Treadmill Exercise, Cooling Gloves, Microbiome Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill ExerciseOther
Participants perform moderate to strenuous exercise for up to 20 minutes on a treadmill after swallowing a microbiome sampling capsule.
Cooling GlovesDevice
Cooling gloves to prevent rise in core body temperature during exercise
Microbiome CapsuleDevice
Capsule used for collecting intestinal tract contents
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Treadmill Exercise; Device: Cooling Gloves; Device: Microbiome Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants completing exercise
Target goal is 80% of subjects will complete their exercise testing
Measured: 1 day
Secondary outcomes (1)
Volume of intestinal fluid from subjects for analysis
Target goal is 80% of subjects to have at least 100ul of intestinal fluid collected from microbiome-sampling capsule
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start4 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Spencer, Stanford University
- Investigators
- Sean P Spencer, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06903806
- Sponsor's protocol ID
- IRB-67010
- Status last verified
- Mar 2025
- First submitted
- 25 Mar 2025
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37165188
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Microbiome Diversity and Inflammation Throughout the GI Tract During Endurance Exercise
- ClinicalTrials.gov ID
- NCT06903806
- Acronym / sponsor ID
- IRB-67010
- Conditions
- Healthy, Exercise-Induced Lactic Acidemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise with microbiome sampling | Experimental | Other: Treadmill Exercise, Device: Cooling Gloves, Device: Microbiome CapsuleParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill ExerciseParticipants perform moderate to strenuous exercise for up to 20 minutes on a treadmill after swallowing a microbiome sampling capsule. | Other | Exercise with microbiome sampling |
| Cooling GlovesCooling gloves to prevent rise in core body temperature during exercise | Device | Exercise with microbiome sampling |
| Microbiome CapsuleCapsule used for collecting intestinal tract contents | Device | Exercise with microbiome sampling |
Primary outcome
Number of participants completing exercise
Time frame: 1 day
Target goal is 80% of subjects will complete their exercise testing
1 secondary outcome
Volume of intestinal fluid from subjects for analysis
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 37165188Shalon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean P Spencer, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Exercise, Cooling Gloves and Microbiome Capsule in people with Healthy and Exercise-Induced Lactic Acidemia, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants completing exercise (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06903806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.