Fecal Metabolome and the Intestinal Microbiota in Irritable Bowel Syndrome (IBS)
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ClinicalTrials.gov Identifier: NCT02981888 |
Recruitment Status :
Recruiting
First Posted : December 5, 2016
Last Update Posted : September 24, 2021
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Condition or disease | Intervention/treatment |
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IBS | Radiation: X-Ray |
There is emerging evidence that alterations in bile acids and SCFA associated with IBS could be associated with changes in the gut microbiota. In addition to modulating levels of intraluminal organic acids, it has been hypothesized that gut microbiota may alter local immune responses, modulate visceral pain responses, and impair gut barrier function.
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
Study Type : | Observational |
Estimated Enrollment : | 90 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome and Control Volunteers |
Study Start Date : | July 2016 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | July 2023 |
Group/Cohort | Intervention/treatment |
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IBS-C
all patients with IBS -C will undergo an abdominal x-ray for assessment of colonic transit
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Radiation: 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
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Radiation: 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
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Radiation: X-Ray
X-ray of the abdomen will be performed to assess colonic transit |
- Total and individual fecal bile acid excretion [ Time Frame: two days ]Stool samples will be collected over 2 days for measurement of fecal bile acids (µmol/48h) by high performance liquid chromatography-mass spectometry
- Total fecal excretion of short chain fatty acids [ Time Frame: two days ]Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry
- Fecal microbial population and community from stool collection [ Time Frame: two days ]Stool samples will be be collected from participants for nucleic acid extraction, 16S allele PCR and sequencing to measure microbial communities and profiles of specimens
- Fecal excretion of individual short chain fatty acids [ Time Frame: two days ]Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry
- Stool characteristics [ Time Frame: 14 days ]Stool characteristics will be measured using a 14 day bowel diary
- Overall and segmental colon transit [ Time Frame: 7 days ]Colonic transit time will be measured in days using radiopaque markers

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients with IBS, ages 18-65 fulfilling Rome IV criteria and asymptomatic controls with no prior history of GI disease or symptoms.
- 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:
- Participants with microscopic/lymphocytic/collagenous colitis, inflammatory bowel disease, celiac disease, visceral cancer, chronic infectious disease, immunodeficiency, uncontrolled thyroid disease, history of liver disease or history of elevated AST/ALT > 2.0x the upper limit of normal
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981888
Contact: Alka Kadariya | (317) 278-9296 | akadariy@iu.edu | |
Contact: Anita Gupta, MBBS,CCRC | (317) 948-9227 | anigupta@iu.edu |
United States, Indiana | |
Indiana University Hospital | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Anita Gupta, MBBS, MPH 317-948-9227 anigupta@iu.edu | |
Sub-Investigator: John Wo, MD | |
Principal Investigator: Andrea Shin, MD | |
Sub-Investigator: Anita Gupta, MBBS, MPH |
Principal Investigator: | Andrea Shin, MD | Indiana University |
Responsible Party: | Andrea Shin, Principal Investigator, Indiana University |
ClinicalTrials.gov Identifier: | NCT02981888 |
Other Study ID Numbers: |
1606244063 |
First Posted: | December 5, 2016 Key Record Dates |
Last Update Posted: | September 24, 2021 |
Last Verified: | September 2021 |
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |