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 @ 5:51 PM
Ignite Modification Date:
2025-12-24 @ 5:51 PM
NCT ID:
NCT04716868
Eligibility Criteria:
Inclusion Criteria:
* Patients over 18 years old.
* functional constipation ROME III criteria as
* Subjects ≥55 years with recent colonoscopy (\<3 years)
Exclusion Criteria:
* Taking supplements of fiber in the last 2 months
* Stimulant laxatives consumption chronically (Senna, Bisacodyl)
* decompensated comorbidities (example: uncontrolled diabetes mellitus HbA1c\> 9%, decompensated Organ failure, decompensated hypertension (untreated or TA\> 160 mmHg systolic and 95 mmHg diastolic)
* Using digital maneuvers or enemas to achieve evacuation
* Personal history of active or previous cancer
* abdominal surgery (except appendectomy, cholecystectomy, hysterectomy)
* Presence of alarm data in the last 6 months (trans-rectal bleeding, unexplained weight loss, abdominal pain)
* Use of drugs known promote constipation (opioid derivatives, calcium channel blockers, anticholinergics tricyclic antidepressants type)
* Prostration (immobility or poor mobility)
* Diseases such as untreated hypothyroidism with hormone replacement, and diseases associated with hypercalcemia that promote constipation
* Other causes of secondary constipation
* Meet criteria for constipation predominant irritable bowel
* Pregnancy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04716868
Study Brief:
Protocol Section:
NCT04716868