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:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 12:20 AM
NCT ID:
NCT04094558
Eligibility Criteria:
Inclusion Criteria
1. Aged between 18 and 70 years.
2. Diagnosis of IBS by Rome 4 criteria (IBS groups) or no previous diagnosis of IBS or suspected IBS (Control group).
3. Ability to understand and provide informed consent.
4. Ability and willingness to meet the required schedule and study interventions.
5. No planned change in diet or medical interventions during the study duration.
6. Adequate mobility to transfer repeatedly between X-ray (standing or lying), and waiting (sitting).
7. Willing and able to undergo a sedated esophagogastroduodenoscopy (EGD) with aspirate and brushing.
Exclusion Criteria
1. Prior gastrointestinal disease, surgery, or radiation treatment which, in the investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion (particular diseases which would be assessed on a case-by-case basis would include, achalasia, eosinophilic esophagitis, Crohn's disease, cancer diagnosis or treatment within the past year, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months prior to enrollment are acceptable).
2. Use of any medications in the previous week that could substantially alter gastrointestinal motor function (e.g., opioids, prokinetics, anticholinergics, laxatives), or acidity (PPI, H2RA).
3. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule.
4. Females of childbearing age who are not practicing birth control and/or are pregnant or lactating.
5. No antibiotics, or colon cleanses/bowel prep for 2 weeks.
6. \< 2 bowel movements per week (Control Group).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04094558
Study Brief:
Protocol Section:
NCT04094558