IBS - Irritable Bowel SyndromeNCT06215222
Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease
An observational study of IBS - Irritable Bowel Syndrome and Healthy, run by Stanford University at 1 site in United States.
Trial summary
We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- IBS - Irritable Bowel Syndrome, Healthy, Functional Bloating
- What is being tested?
- Microbiota Sampling
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to 1 Dec 2026
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Subjects or those with clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)
Who may be able to join
- Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.
- American Society of Anesthesiologists (ASA) Physical Status Classification System 1 or 2 (1-A normal healthy patient or 2-A patient with mild systemic disease)
- 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.
- Positive for at least one clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)
Who cannot join
- 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
Show all 14Show fewer
- 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
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 Digestive Health Clinic
Redwood City, California, 94063
Sean Spencer, MD/PhD, 650-736-5555, seanspen@stanford.edu
Linda Nguyen, MD, (650) 736-5555
About this study
We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.
- Conditions
- IBS - Irritable Bowel Syndrome, Healthy, Functional Bloating, Functional Gastrointestinal Disorders
- Being tested
- Microbiota Sampling
- Keywords
- microbiome, Small intestine
- Medical subject headings
- Irritable Bowel Syndrome, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiota SamplingOther
We will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation
| Study group | Role | What they receive |
|---|---|---|
| Healthy patients | Healthy Patients Receives: Other: Microbiota Sampling | |
| IBS/Functional GI diasease | Patients with IBS or Functional GI disease (bloating, diarrhea, constipation) Receives: Other: Microbiota Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules
Collection of 50ul of intestinal fluid from microbiome sampling capsules
Measured: 1-4 years
Secondary outcomes (1)
Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules
Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules
Measured: 1-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start16 Nov 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Spencer, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215222
- Sponsor's protocol ID
- IRB-62670
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease
- ClinicalTrials.gov ID
- NCT06215222
- Acronym / sponsor ID
- IRB-62670
- Conditions
- IBS - Irritable Bowel Syndrome, Healthy, Functional Bloating, Functional Gastrointestinal Disorders
- Keywords
- microbiome, Small intestine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Jan 2024 (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.
We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy patients | – | Other: Microbiota SamplingHealthy Patients |
| IBS/Functional GI diasease | – | Other: Microbiota SamplingPatients with IBS or Functional GI disease (bloating, diarrhea, constipation) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Subjects or those with clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)
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.
- American Society of Anesthesiologists (ASA) Physical Status Classification System 1 or 2 (1-A normal healthy patient or 2-A patient with mild systemic disease)
- 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.
- Positive for at least one clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)
Key exclusion criteria (14 listed)
- History of any of the following:
- 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
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 |
|---|---|---|
| Microbiota SamplingWe will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation | Other | Healthy patients, IBS/Functional GI diasease |
Primary outcome
Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules
Time frame: 1-4 years
Collection of 50ul of intestinal fluid from microbiome sampling capsules
1 secondary outcome
Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules
Time frame: 1-4 years
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 22 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IBS - Irritable Bowel Syndrome and Healthy, 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 14 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 22 Jan 2024. 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?
Contact Sean Spencer, MD,PhD ((650) 736-5555, seanspen@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules (time frame: 1-4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2024.