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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT04757493
Eligibility Criteria:
Inclusion Criteria:
* Age:18-65 years.
* Patients who will Meet Rome IV criteria for IBS-Constipation (IBS-C).
* Patients classified as IBS-C had \> 25% hard or lumpy stool (Bristol stool scale 1-2) and \< 25% loose or watery (Bristol stool scale 6-7).
* Absence of alarm features (rectal bleeding, anemia, unexplained weight loss, and a family history of organic GI diseases (e.g. colon cancer or inflammatory bowel disease).
* Patients more than 55 years when full colonoscopy will normal.
* Patients given informed written consent.
Exclusion Criteria:
* Current treatment with laxative and Selective Serotonin Re-uptake Inhibitor.
* Unable or Unwilling to stop medication including lactulose, lubiprostone etc.
* Known organic bowel diseases (e.g. inflammatory bowel disease, tuberculosis, diverticular disease, etc.).
* Secondary causes of constipation e.g. Diabetes Mellitus, Hypothyroidism, Cerebrovascular disease and Parkinsonism. Known severe depression and psychiatric disorder.
* Clinical feature suggestive of organic disease (H/O weight loss, per rectal bleeding, family history of malignancy etc).
* Previous GI surgery.
* Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04757493
Study Brief:
Protocol Section:
NCT04757493