Evaluation of Stool Microbiome Using HyGIeaCare Prep

  • STATUS
    Recruiting
  • participants needed
    14
  • sponsor
    HyGIeaCare, Inc.
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Updated on 19 February 2024
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Summary

Stool samples will be collected before and during the HyGIeaCare procedure and the samples will be sent for microbiome evaluation.

Description

Patients will have the HyGIeaCare procedure as originally prescribed by their physician. Before and during the procedure stool samples will be collected and sent to a lab for microbiome evaluation.

It is anticipated that stool samples collected from the HyGIeaCare prep will provide more microbiological and biochemical information on the gut interior than using traditional stool samples.

Details
Condition Stool Microbiome
Age 18years - 80years
Treatment Stool sample evaluation
Clinical Study IdentifierNCT04264923
SponsorHyGIeaCare, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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