Fecal Metabolome and the Intestinal Microbiota in Irritable Bowel Syndrome

NCT02981888 | Completed

• 1 other identifier: 1606244063
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

IBS

Outcome Measures

Primary Outcomes (3)

• Total and individual fecal bile acid excretion

  Stool samples will be collected over 2 days for measurement of fecal bile acids (µmol/48h) by high performance liquid chromatography-mass spectometry

  two days

• Total fecal excretion of short chain fatty acids

  Stool samples will be collected for measurement of measurement of short chain fatty acids (µg/mg) by liquid chromatography-mass spectrometry

  two days

• Fecal microbial population and community from stool collection

  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

  two days

Secondary Outcomes (2)

• Fecal excretion of individual short chain fatty acids

  two days

• Stool characteristics

  14 days

Other Outcomes (1)

• Overall and segmental colon transit

  7 days

Study Arms (3)

IBS-C

all patients with IBS -C will undergo an abdominal x-ray for assessment of colonic transit

Radiation: X-Ray

IBS-D

all patients with IBS-D will undergo an abdominal x-ray for assessment of colonic transit

Radiation: X-Ray

heathy control

all healthy controls will undergo an abdominal x-ray for assessment of colonic transit

Radiation: X-Ray

Interventions

X-Ray RADIATION

X-ray of the abdomen will be performed to assess colonic transit

IBS-C; IBS-D; heathy control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target study population will be patients with IBS (both diarrhea- and constipation-predominant) and healthy controls.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 36227781 DERIVED

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Andrea Shin, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: December 5, 2016
• Study Start: July 1, 2016
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

US (1)