Evaluation of Stool Microbiome Using HyGIeaCare Prep
Completed · Not applicable
Conditions studied: Stool Microbiome
In brief
Stool samples will be collected before and during the HyGIeaCare procedure and the samples will be sent for microbiome evaluation.
Key facts
- Study ID
- NCT04264923
- Run by
- HyGIeaCare, Inc.
- People needed
- 14
- Starts
- 2019-06-27
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2020-07-31
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 scheduled for elective screening or polyp surveillance indicated colonoscopy
- Patient does not have any known health issues (as listed in exclusion criteria)
- Patient had not taken antibiotics within the last 2 months
You may not qualify if…
- Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation), chronic diarrhea or chronic constipation (requiring pharmacologic prescription treatment)
- Patient has secondary constipation (colonic obstruction, medications, metabolic cause)
- 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
- 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, inflammatory bowel disease. History of gastrointestinal surgery- (small bowel, colon. Bariatric 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 — Norfolk, Virginia, United States
Full record on ClinicalTrials.gov
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