Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Fecal Metabolome and the Intestinal Microbiota in Irritable Bowel Syndrome (IBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02981888
Recruitment Status : Recruiting
First Posted : December 5, 2016
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Andrea Shin, Indiana University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to find out the relationship between the bile acids, fatty acids (fatty acids are part of the diet) and bacteria that are present in the intestines.

Condition or disease Intervention/treatment
IBS Radiation: X-Ray

Detailed Description:

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

Drug Information available for: X-Rays

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
IBS-C
all patients with IBS -C will undergo an abdominal x-ray for assessment of colonic transit
 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
 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
 Radiation: X-Ray
X-ray of the abdomen will be performed to assess colonic transit


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. Stool characteristics [ Time Frame: 14 days ]
    Stool characteristics will be measured using a 14 day bowel diary


Other Outcome Measures:
  1. Overall and segmental colon transit [ Time Frame: 7 days ]
    Colonic transit time will be measured in days using radiopaque markers


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Study Population
The target study population will be patients with IBS (both diarrhea- and constipation-predominant) and healthy controls.
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Alka Kadariya (317) 278-9296 akadariy@iu.edu
Contact: Anita Gupta, MBBS,CCRC (317) 948-9227 anigupta@iu.edu

Locations
Layout table for location information
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         
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Andrea Shin, MD Indiana University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases