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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT04106232
Eligibility Criteria:
Inclusion Criteria:
1. Patient's age is between 18 and 80 years old.
2. For the healthy population - Indication for age-appropriate colorectal cancer screening colonoscopy
3. Adequate capacity to consent to study
4. Patient does not have any known health issues, except for chronic constipation for the "chronic constipation" population.
5. Patient has not taken antibiotics within the last three (3) months.
6. For chronically constipated patients - \>3 months of symptomatic constipation with first onset of constipation more than 6 months ago.
For chronically constipated patients - Diagnosis of functional constipation by Modified Rome IV Diagnostic Criteria.
Exclusion Criteria:
1. Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation).
2. Patient has any other condition that, in the opinion of the investigator, may adversely affect the compliance or safety of the patient or would limit the patient's ability to complete the study.
3. Current, or recent (within three months) antibiotic usage
Patient has any of the contraindications listed below:
4. Cardiac: Congestive heart failure (NYHA class III or IV or EF \<50%)
5. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery
6. GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
7. Abdominal surgery within the last 6 months
8. Pregnancy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04106232
Study Brief:
Protocol Section:
NCT04106232