NCT03266068

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

3.5 years

First QC Date

July 5, 2017

Last Update Submit

January 19, 2022

Conditions

Campylobacter InfectionsIrritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Colonic geometric center at 24 hours

    The scintigraphic method is used to measure colonic transit. An isotope is adsorbed on activated charcoal particles and delivered to the colon in a delayed release capsule. Anterior and posterior gamma images are taken hourly. The geometric center (GC) is the weighted average of counts in the different colonic regions. The scale ranges from 1 to 5; a high GC implies faster colonic transit, a GC of 1 implies all isotope is in the ascending colon, and a GC of 5 implies all isotope is in the stool.

    24 hours

Study Arms (3)

Post Infectious IBS Case

Subjects who have suffered from acute bacterial gastroenteritis within last two years and have developed some symptoms that might be suggestive of post-infectious irritable bowel syndrome (IBS). Subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.

Genetic: DNA Analysis of Blood SampleProcedure: Flexible sigmoidoscopy with colonic biopsiesProcedure: Small bowel and colonic gastrointestinal permeabilityDiagnostic Test: Stool sample analysis

Post Infectious with no IBS Control

Subjects who have suffered from acute bacterial gastroenteritis within last two years and have not developed symptoms suggestive of post-infectious irritable bowel syndrome (IBS). Subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.

Genetic: DNA Analysis of Blood SampleProcedure: Flexible sigmoidoscopy with colonic biopsiesProcedure: Small bowel and colonic gastrointestinal permeabilityDiagnostic Test: Stool sample analysis

Healthy Control

Healthy volunteers; subjects will receive a DNA analysis of blood sample, flexible sigmoidoscopy with colonic biopsies, small bowel and colonic gastrointestinal permeability, and stool sample analysis.

Genetic: DNA Analysis of Blood SampleProcedure: Flexible sigmoidoscopy with colonic biopsiesProcedure: Small bowel and colonic gastrointestinal permeabilityDiagnostic Test: Stool sample analysis

Interventions

DNA Analysis of Blood SampleGENETIC

DNA analysis of the genes possibly involved in IBS.

Healthy ControlPost Infectious IBS CasePost Infectious with no IBS Control
Flexible sigmoidoscopy with colonic biopsiesPROCEDURE

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

Healthy ControlPost Infectious IBS CasePost Infectious with no IBS Control
Small bowel and colonic gastrointestinal permeabilityPROCEDURE

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

Healthy ControlPost Infectious IBS CasePost Infectious with no IBS Control
Stool sample analysisDIAGNOSTIC_TEST

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.

Healthy ControlPost Infectious IBS CasePost Infectious with no IBS Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Post Infectious IBS Cases Post Infectious with no IBS Controls Healthy Volunteer Controls

You may qualify if:

  • IBS by Rome III criteria
  • No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and cholecystectomy)
  • No IBS by Rome III criteria
  • No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and cholecystectomy)

You may not qualify if:

  • Prior history of IBS or inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease
  • Ingestion of artificial sweeteners such as sucralose, aspartame, lactulose or mannitol 2 days before the study begins, e.g., foods to be avoided are sugarless gums or mints and diet soda
  • Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins
  • Any treatment specifically taken for IBS, including loperamide, cholestyramine, alosetron
  • Drugs with a known pharmacological activity at serotonin type 4 (5-HT4), serotonin receptor 2B (5-HT2b) or 5-HT3 receptors (e.g, tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazapine)
  • All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in combination)
  • Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline)
  • Ultram
  • GI preparations
  • Anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine, dimenhydrinate, hydroxyzine)
  • Osmotic laxative agents (e.g, lactulose, sorbitol or polyethylene glycol (PEG) solutions as Miralax and Glycolax)
  • Prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone)
  • Antimuscarinics
  • Peppermint oil
  • Systemic antibiotics, rifaximin, metronidazole
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool, and tissue samples

MeSH Terms

Conditions

Campylobacter InfectionsIrritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsColonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Madhusudan Grover, MBBS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 5, 2017

First Posted

August 29, 2017

Study Start

September 1, 2016

Primary Completion

March 11, 2020

Study Completion

March 11, 2020

Last Updated

January 20, 2022

Record last verified: 2022-01

Locations

US(1)