ObesityNCT02863029
Defining the Role of the Gut Microbiome in Mediating the Effects of Obesity on Intestinal Stem Cells
A study testing Flexible Sigmoidoscopy in people with Obesity, run by Mayo Clinic at 1 site in United States.
Trial summary
New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The investigators would like to study how obesity influences growth of intestinal stem cells, which could then trigger intestinal tumors. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Flexible Sigmoidoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 9 Mar 2017
- Phase
- Interventional
- 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
Who may be able to join
None listed.
Who cannot join
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions or diabetes mellitus
- 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)
- Bowel preparation for colonoscopy within the past week
- Significant bowel surgery other than hysterectomy or appendectomy
- Pregnancy or plans to become pregnant within the study time frame
- Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
- Age<18 or vulnerable adults -
Trial locations and contacts
1 site in 1 country.
About this study
New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The investigators would like to study how obesity influences growth of intestinal stem cells, which could then trigger intestinal tumors.
The investigators are proposing a Pilot Study of 20 subjects (comprised of 10 participants from each of two different BMI categories: 20-25 and 35 \& above), who will be asked to provide blood, stool, \& urine samples, undergo a flexible sigmoidoscopy, and complete food frequency questionnaires
Read the detailed description
Hypothesis:
The investigators will test the hypothesis that the gut microbiome drives many of the effects that a pro-obesity high-fat diet has on intestinal stem cell (ISC) biology, which includes 1) an increase in ISC numbers and proliferation, 2) a reduced dependency on niche cells for intestinal organoid initiation, or 3) the acquisition of organoid-initiation by non-stem cell population in the intestinal epithelium.
Specific Aims:
- To determine whether differences in the gut microbiome in obese human subjects correlates with enhanced intestinal stem cell numbers and function.
- To validate whether obesity-driven changes in the gut microbiome of human recapitulate the effects of obesity on intestinal stem cell function in germ-free mice.
- Conditions
- Obesity
- Being tested
- Flexible Sigmoidoscopy
- Keywords
- Intestinal stem cells
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible SigmoidoscopyProcedure or surgery
A sigmoidoscopy is the minimally invasive medical examination of the large intestine from the rectum through the last part of the colon, using a flexible endoscope.
| Study group | Role | What they receive |
|---|---|---|
| Flexible Sigmoidoscopy | Other | Participants will undergo an unsedated Flexible Sigmoidoscopy in order to obtain 12 mucosal biopsies. Serum cholesterol, triglyceride and HBA1C levels will be determined. Plasma, serum and whole blood will be stored for future use for next generation sequencing and metabolomics to determine the effect of different genetic loci on composition and function of gut microbiota Receives: Procedure: Flexible Sigmoidoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the growth of intestinal stem cells
The gut microbiome is altered in obesity and studying intestinal stem cells will be helpful in learning what triggers intestinal tumors.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startJan 2017
- Primary completion9 Mar 2017
- Study completion9 Mar 2017
Why it stopped: Recruitment difficulty
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Purna C. Kashyap, MBBS, Mayo Clinic
- Investigators
- Purna C Kashyap, M., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02863029
- Sponsor's protocol ID
- 16-003158
- Status last verified
- Feb 2022
- First submitted
- 3 Aug 2016
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Tissue samples will be sent to the Massachusetts Institute of Technology (MIT)
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Role of the Gut Microbiome in Mediating the Effects of Obesity on Intestinal Stem Cells
- ClinicalTrials.gov ID
- NCT02863029
- Acronym / sponsor ID
- 16-003158
- Conditions
- Obesity
- Keywords
- Intestinal stem cells
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulty
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 11 Aug 2016 (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.
New studies are revealing how a high-fat diet could be making the cells of the intestinal lining more likely to become cancerous. The investigators would like to study how obesity influences growth of intestinal stem cells, which could then trigger intestinal tumors.
The investigators are proposing a Pilot Study of 20 subjects (comprised of 10 participants from each of two different BMI categories: 20-25 and 35 \& above), who will be asked to provide blood, stool, \& urine samples, undergo a flexible sigmoidoscopy, and complete food frequency questionnaires
Detailed description
Hypothesis:
The investigators will test the hypothesis that the gut microbiome drives many of the effects that a pro-obesity high-fat diet has on intestinal stem cell (ISC) biology, which includes 1) an increase in ISC numbers and proliferation, 2) a reduced dependency on niche cells for intestinal organoid initiation, or 3) the acquisition of organoid-initiation by non-stem cell population in the intestinal epithelium.
Specific Aims:
- To determine whether differences in the gut microbiome in obese human subjects correlates with enhanced intestinal stem cell numbers and function.
- To validate whether obesity-driven changes in the gut microbiome of human recapitulate the effects of obesity on intestinal stem cell function in germ-free mice.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flexible Sigmoidoscopy | Other | Procedure: Flexible SigmoidoscopyParticipants will undergo an unsedated Flexible Sigmoidoscopy in order to obtain 12 mucosal biopsies. Serum cholesterol, triglyceride and HBA1C levels will be determined. Plasma, serum and whole blood will be stored for future use for next generation sequencing and metabolomics to determine the effect of different genetic loci on composition and function of gut microbiota |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions or diabetes mellitus
- 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)
- Bowel preparation for colonoscopy within the past week
- Significant bowel surgery other than hysterectomy or appendectomy
- Pregnancy or plans to become pregnant within the study time frame
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 |
|---|---|---|
| Flexible SigmoidoscopyA sigmoidoscopy is the minimally invasive medical examination of the large intestine from the rectum through the last part of the colon, using a flexible endoscope. | Procedure or surgery | Flexible Sigmoidoscopy |
Primary outcome
Changes in the growth of intestinal stem cells
Time frame: Two years
The gut microbiome is altered in obesity and studying intestinal stem cells will be helpful in learning what triggers intestinal tumors.
Results and safety
The study was stopped early (reason given: Recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Tissue samples will be sent to the Massachusetts Institute of Technology (MIT)
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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. This study is not recruiting at the moment.
Purna C Kashyap, M. 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?
A study testing Flexible Sigmoidoscopy in people with Obesity, 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 0 inclusion and 7 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: stopped early, as of the sponsor's last update on 18 Feb 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 was stopped early (reason given: Recruitment difficulty). Results are not available in the source record.
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?
Changes in the growth of intestinal stem cells (time frame: Two 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 18 Feb 2022.