Irritable Bowel SyndromeNCT02249169
Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by Mayo Clinic at 1 site in United States.
Trial summary
This longitudinal study is being done to understand mechanisms underlying development of irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2014to 8 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Motility Clinic, Clinical Research Unit, GI Department
Who may be able to join
- Clinical diagnosis of IBS-C or IBS-D
- Age 18 to 65
- Age 18 to 65
- No clinical diagnosis of IBS-C or IBS-D
Who cannot join
- Prior history of abdominal surgeries (except appendectomy and cholecystectomy)
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition
- Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)
- Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy
- Bowel preparation for colonoscopy within the past week
- Pregnancy or plans to become pregnant within the study time frame
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- Vulnerable adults
- Age greater than or equal to 66
- Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes
- HEALTHY SUBJECTS:
- Prior history of abdominal surgeries (except appendectomy and cholecystectomy)
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition
- Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)
- Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy
- Bowel preparation for colonoscopy within the past week
- Pregnancy or plans to become pregnant within the study time frame
- Vulnerable adults
- Age greater than or equal to 66
- Any other disease(s), condition(s) or habit(s) that would interfere with completion of the study, would increase risks of flexible sigmoidoscopy (for those opting for this), or in the judgment of the investigator would potentially interfere compliance to this study or would adversely affect study outcomes
- Clinical diagnosis of IBS-C or IBS-D
Trial locations and contacts
1 site in 1 country.
About this study
This longitudinal study is being done to understand mechanisms underlying development of irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms. This information will be used to determine whether temporal changes in gut microbial taxonomy and metabolism are associated with changes in symptom severity in IBS, and if targeted dietary interventions, including prebiotics, can reverse or moderate these changes.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| IBS-C | Patients with a clinical diagnosis of constipation-predominant irritable bowel syndrome | |
| IBS-D | Patients with a clinical diagnosis of diarrhea-predominant irritable bowel syndrome | |
| Healthy subjects | Subjects without a clinical diagnosis of IBS-C or IBS-D | |
| Healthy Controls | Subject without a clinical diagnosis of IBS-C or IBS-D and who is either a first-degree relative of an IBS participant or is not genetically related but resides with the IBS participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months
Participants will provide a stool sample at baseline and at periodic intervals for 6 months to assess gut microbial composition.
Measured: baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study start19 Sep 2014
- Primary completion8 Feb 2017
- Study completion8 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Purna C. Kashyap, MBBS, Mayo Clinic
- Investigators
- Purna C. Kashyap, M.B.B.S., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249169
- Sponsor's protocol ID
- 14-000305
- Status last verified
- Aug 2022
- First submitted
- 19 Sep 2014
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Novel Microbiota-Targeted Therapies for Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02249169
- Acronym / sponsor ID
- 14-000305
- Conditions
- Irritable Bowel Syndrome
- Keywords
- IBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- 19 Sep 2014 (actual)
- Primary completion
- 8 Feb 2017 (actual)
- Study completion
- 8 Feb 2017 (actual)
- First posted
- 25 Sep 2014 (estimated)
- 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.
This longitudinal study is being done to understand mechanisms underlying development of irritable bowel syndrome (IBS) and the role of the gut bacteria in development of symptoms. This information will be used to determine whether temporal changes in gut microbial taxonomy and metabolism are associated with changes in symptom severity in IBS, and if targeted dietary interventions, including prebiotics, can reverse or moderate these changes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IBS-C | – | –Patients with a clinical diagnosis of constipation-predominant irritable bowel syndrome |
| IBS-D | – | –Patients with a clinical diagnosis of diarrhea-predominant irritable bowel syndrome |
| Healthy subjects | – | –Subjects without a clinical diagnosis of IBS-C or IBS-D |
| Healthy Controls | – | –Subject without a clinical diagnosis of IBS-C or IBS-D and who is either a first-degree relative of an IBS participant or is not genetically related but resides with the IBS participant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Motility Clinic, Clinical Research Unit, GI Department
Key inclusion criteria (4 listed)
- Clinical diagnosis of IBS-C or IBS-D
- Age 18 to 65
- Age 18 to 65
- No clinical diagnosis of IBS-C or IBS-D
Key exclusion criteria (20 listed)
- Prior history of abdominal surgeries (except appendectomy and cholecystectomy)
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory condition
- Antibiotic use within the past 4 weeks (they can be enrolled after a four-week washout period and subsequent use during the 6-month study duration does not exclude them)
- Bleeding risk or medications which may increase risk of bleeding for patients who agree to undergo flexible sigmoidoscopy
- Bowel preparation for colonoscopy within the past week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months
Time frame: baseline, 6 months
Participants will provide a stool sample at baseline and at periodic intervals for 6 months to assess gut microbial composition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Irritable Bowel Syndrome
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NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
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. This study is not recruiting at the moment.
Purna C. Kashyap, M.B.B.S. principal investigator
Mayo Clinic
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 Irritable Bowel Syndrome, run by Mayo Clinic 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 4 inclusion and 20 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: finished, as of the sponsor's last update on 17 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiome in patients with IBS compared to healthy individuals measured over 6 months (time frame: baseline, 6 months). 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 17 Aug 2022; AzTrials last refreshed its copy on 1 Nov 2026.