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Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders

NCT03266068 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2022-01-20

No results posted yet for this study

Summary

Some people develop chronic abdominal pain with diarrhea or constipation after an episode of acute bacterial gastroenteritis. These symptoms can be consistent with post-infectious irritable bowel syndrome (IBS) and can last long after the acute infection is over. The exact reason why certain individuals develop these symptoms whereas others don't is not exactly clear.

The researchers are studying changes in gastrointestinal permeability (movement of contents across the lining of the intestine) and transit (movement of food through the gastrointestinal tract). The researchers are also studying if there are any genetic risk factors that are associated with development of this disorder.

Conditions

  • Campylobacter Infections
  • Irritable Bowel Syndrome

Interventions

GENETIC

DNA Analysis of Blood Sample

DNA analysis of the genes possibly involved in IBS.

PROCEDURE

Flexible sigmoidoscopy with colonic biopsies

Endoscopy of the subject's lower colon in which biopsies of the lining of the colon will be taken.

PROCEDURE

Small bowel and colonic gastrointestinal permeability

A validated scintigraphic method to measure gastric, small bowel and colonic transit will be used.

DIAGNOSTIC_TEST

Stool sample analysis

Stool samples will be used to extract supernatants. These supernatants will be studied in using chamber set-up to determine barrier effects on T84 monolayers.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Madhusudan Grover, MBBS · Mayo Clinic

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-03-11
Completion
2020-03-11

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03266068 on ClinicalTrials.gov