Epidemiology and Pathophysiology of Post-Infectious Functional GI Disorders

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 12-006529
    NCT ID: NCT03266068
    Sponsor Protocol Number: 12-006529

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

Post Infectious IBS Cases Inclusion Criteria:

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

Post Infectious with no IBS Controls Inclusion Criteria:

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

Healthy Control Inclusion Criteria:

  1. No abdominal surgery (except hernia, C-section, hysterectomy, appendectomy and cholecystectomy)
  2. No history of acute gastroenteritis, food-poisoning or travel related diarrhea within last 2 years.

Exclusion Criteria:

Post Infectious IBS Cases and Post Infectious with no IBS Controls Exclusion Criteria:

  1. Prior history of IBS or inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease
  2. 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
  3. Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins
    1. Any treatment specifically taken for IBS, including loperamide, cholestyramine, alosetron
    2. 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)
    3. All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in combination)
    4. Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline)
    5. Ultram
    6. 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)
    7. Antimuscarinics
    8. Peppermint oil
    9. Systemic antibiotics, rifaximin, metronidazole
  4. Any females who are pregnant or trying to become pregnant (due to radiation exposure)
  5. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies

Healthy Control Exclusion Criteria:

  1. Prior history of IBS or IBD (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease
  2. 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
  3. Ingestion of any prescription, over the counter, or herbal medications which can affect gastrointestinal transit 7 days before study begins
    1. Any treatment specifically taken for IBS, including loperamide, cholestyramine, alosetron
    2. Drugs with a known pharmacological activity at 5-HT4, 5-HT2b or 5-HT3 receptors (e.g, tegaserod, ondansetron, tropisetron, granisetron, dolasetron, mirtazapine)
    3. All narcotics (e.g, codeine, morphine, and propoxyphene, either alone or in combination)
    4. Anti-cholinergic agents (e.g, dicyclomine, hyoscyamine, propantheline)
    5. Ultram
    6. GI preparations
      • Anti-nausea agents (e.g, trimethobenzamide, promethazine, prochlorperazine, dimenhydrinate, hydroxyzine)
      • Osmotic laxative agents (e.g, lactulose, sorbitol or PEG solutions as Miralax and Glycolax)
      • Prokinetic agents (e.g, cisapride, metoclopramide, itopride, domperidone)
    7. Antimuscarinics
    8. Peppermint oil
    9. Systemic antibiotics, rifaximin, metronidazole
  4. Any females who are pregnant or trying to become pregnant (due to radiation exposure)
  5. Bleeding disorders or medications that increase risk of bleeding from mucosal biopsies

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Madhusudan Grover, M.B.B.S.

Open for enrollment

Contact information:

Wendy Sundt

(507)266-6004

Sundt.Wendy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20317678

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