Fecal Metabolome and the Intestinal Microbiota in Irritable Bowel Syndrome
NCT ID: NCT02981888
Last Updated: 2024-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2016-07-01
2023-04-27
Brief Summary
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Detailed Description
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Our overall goal is to investigate the relationship between fecal bile acids, SCFA and the gut microbiota in IBS. Results of this pilot study could reveal insights into the interplay of the gut microbiota and small molecule mediators of IBS to suggest targeted clinical strategies for improved diagnosis and management of this important syndrome.
AIM 1: Test the hypothesis that fecal organic acids (SFCA and bile acids) and fecal microbiota play an important role in IBS.
AIM 2: Test the hypothesis that there is association between colonic transit and fecal microbiota in IBS
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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IBS-C
all patients with IBS -C will undergo an abdominal x-ray for assessment of colonic transit
X-Ray
X-ray of the abdomen will be performed to assess colonic transit
IBS-D
all patients with IBS-D will undergo an abdominal x-ray for assessment of colonic transit
X-Ray
X-ray of the abdomen will be performed to assess colonic transit
heathy control
all healthy controls will undergo an abdominal x-ray for assessment of colonic transit
X-Ray
X-ray of the abdomen will be performed to assess colonic transit
Interventions
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X-Ray
X-ray of the abdomen will be performed to assess colonic transit
Eligibility Criteria
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Inclusion Criteria
* Participants should be on a stable and consistent diet regimen and should not be following an extreme diet intervention such as gluten-free or a low FODMAP diet at the time of study participation.
Exclusion Criteria
* Prior radiation therapy of the abdomen or abdominal surgeries with the exception of appendectomy or cholecystectomy \> 6 months prior to study initiation
* Ingestion of any prescription, over the counter, or herbal medications which can affect GI transit or study interpretation (e.g. opioids, narcotics, anticholinergics, norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, COX-2 inhibitors, bile acid sequestrants) within 6 months of study initiation for asymptomatic volunteers or within 2 days before study initiation for IBS patients
* Any females who are pregnant or trying to become pregnant or breast-feeding
* Antibiotic usage within 3 months prior to study participation
* Prebiotic or probiotic usage within the 2 weeks prior to study initiation
* Use of tobacco products within the past 6 months.
18 Years
65 Years
ALL
Yes
Sponsors
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Indiana University
OTHER
Responsible Party
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Huiping Xu
Associate Professor
Principal Investigators
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Andrea Shin, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Indiana University Hospital
Indianapolis, Indiana, United States
Countries
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References
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Waseem MR, Shin A, Siwiec R, James-Stevenson T, Bohm M, Rogers N, Wo J, Waseem L, Gupta A, Jarrett M, Kadariya J, Xu H. Associations of Fecal Short Chain Fatty Acids With Colonic Transit, Fecal Bile Acid, and Food Intake in Irritable Bowel Syndrome. Clin Transl Gastroenterol. 2023 Jan 1;14(1):e00541. doi: 10.14309/ctg.0000000000000541.
Other Identifiers
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1606244063
Identifier Type: -
Identifier Source: org_study_id
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