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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07386795
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with functional constipation (FC) according to Rome IV criteria.
* Symptoms persisting for at least 6 months, with criteria met for the last 3 months.
* Ineffective response to traditional treatments (dietary intervention, at least 2 types of laxatives, or probiotics).
* Willing to discontinue other constipation medications, herbal medicines, or supplements during the study.
Exclusion Criteria:
* History or clinical evidence of mechanical bowel obstruction (e.g., tumor or hernia).
* Diagnosis of megarectum, megacolon, or pseudo-obstruction.
* Organic intestinal abnormalities (obstruction, stenosis, cancer) or inflammatory bowel disease (IBD).
* Progressive colorectal polyps requiring treatment.
* History of gastrointestinal or abdominal surgery within the past 3 months.
* Severe cardiovascular or cerebrovascular diseases.
* Clinically significant liver function abnormalities (ALT/AST \> 2x ULN, TBIL ≥ 1.5x ULN).
* Pregnancy, lactation, or planning to conceive during the study.
* Inability to undergo colonoscopy or catheter placement.
* Participation in other clinical trials within the past 3 months.
* Other health conditions deemed unsuitable by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07386795
Study Brief:
Protocol Section:
NCT07386795