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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT03620994
Eligibility Criteria:
Inclusion Criteria:
1. Presence of Irritable bowel syndrome symptoms，that is，recurrent abdominal pain, on average, at least 1 day per week in the last 3 months, associated with 2 or more of the following criteria:
Related to defecation;
Associated with a change in frequency of stool;
Associated with a change in form (appearance) of stool.
（Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.）
2. Aged 18 years and older;
3. August 2018 to March 2019, patients went to the Gastroenterology clinics of the second affiliated hospital of Xi'an JiaoTong University, Xijing Hospital ,Tangdu Hospital or affiliated hospital of Northwest University , and received Colonoscopy;
4. Blood routine examination, fecal routine examination, and fecal occult blood test were conducted within 6 months.
Exclusion Criteria:
1. Previously diagnosed with diseases that better explain the participant's IBS symptoms (e.g. celiac disease, colorectal cancer, inflammatory bowel disease, microscopic colitis, lactose intolerance, bile acid malabsorption, intestinal tuberculosis, diverticulosis, ischemic enteritis, etc.);
2. Metabolic disease: uncontrolled thyroid disease and diabetes;
3. Severe neurological and psychiatric disorders, which may impede conduct of the clinical trial. These disorders include but are not limited to major depression with a high risk of suicidal behavior (i.e. intent or plan), alcohol or substance abuse/dependence, a lifetime history of psychosis;
4. Participant has an unstable severe extraintestinal medical condition (such as heart, liver, kidney and respiratory failure) with immediate or foreseeable treatment needs;
5. Previous major abdominal surgery that would have resulted in significant changes in the anatomy or physiology of the gastrointestinal tract, which can fully explain GI symptoms. Note: appendectomy, cholecystectomy, endoscopic polypectomy, endoscopic mucosal resection and endoscopic submucosal resection are not excluded criteria;
6. Were pregnant, might become pregnant, or were lactating;
7. Colonoscopy for structural evaluation of the GI tract in the past 6 months due to their IBS symptoms;
8. Taking anti-anxiety, anti-depressant drugs or intestinal sensitive antibiotics recently;
9. A current infection or infection of any type within the 2 weeks prior to evaluation that would obscure the presentation of IBS symptoms, in which case the assessment can be delayed until 2 weeks after full recovery;
10. Currently diagnosed malignancy, with exception of localized basal or squamous cell carcinomas of the skin which is completely removed. The so-called "current" means that the diagnosis of any malignancy (except basal cells or squamous cell carcinoma) that is active occurs within the first 12 months of enrollment;
11. Refusal to participate in this study or who cannot follow the research requirements for various reasons.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03620994
Study Brief:
Protocol Section:
NCT03620994