Microbiome Analysis of Constipated Versus Non-constipation Patients
Completed
Conditions studied: Rome IV Functional Constipation
In brief
This study intends to evaluate the microbiome of chronically constipated patients as compared to those with a non-constipated gastrointestinal system.
Key facts
- Study ID
- NCT04106232
- Run by
- HyGIeaCare, Inc.
- People needed
- 30
- Starts
- 2020-01-24
- Expected to finish
- 2023-03-06
- Last updated by the study team
- 2023-04-27
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patient's age is between 18 and 80 years old.
- For the healthy population - Indication for age-appropriate colorectal cancer screening colonoscopy
- Adequate capacity to consent to study
- Patient does not have any known health issues, except for chronic constipation for the "chronic constipation" population.
- Patient has not taken antibiotics within the last three (3) months.
- 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.
You may not qualify if…
- Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation).
- 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.
- Current, or recent (within three months) antibiotic usage
- Patient has any of the contraindications listed below:
- Cardiac: Congestive heart failure (NYHA class III or IV or EF <50%)
- GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery
- GU: Renal insufficiency (CC < 60 ml/min/173m2), cirrhosis with ascites
- Abdominal surgery within the last 6 months
- Pregnancy
Where it is running
- Hygieacare Center - Flowood — Flowood, Mississippi, United States
- Hygieacare - Norwood — Cincinnati, Ohio, United States
- HyGIeaCare Center — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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