Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT03266068
Eligibility 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)
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 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.
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03266068
Study Brief:
Protocol Section:
NCT03266068