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OpenTrials
Completed

NCT Number: NCT04264923

Evaluation of Stool Microbiome Using HyGIeaCare Prep

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

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HyGIeaCare Center

Norfolk, Virginia, 78744, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HyGIeaCare Prep

Other

Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents.

Other names: Stool sample evaluation

Primary outcomes

  1. Microbial classification

    Time frame: 6 months

    The number of genes present will be counted

  2. Diversity between stool and colon effluent samples

    Time frame: 6 months

    Alpha diversity by Shannon diversity index, presence and number of taxa to be documented

  3. Inner diversity of samples

    Time frame: 6 months

    ANOVA test will be used to acknowledge differences between samples, presence and number of taxa to be documented

  4. Contribution of the variables to samples' diversity

    Time frame: 6 months

    Principal component analysis (PCoA) will be used to mark significant differences between the samples, taxa will be identified by presence, percentage of sample will be documented

Secondary outcomes

  1. Functional genes analysis

    Time frame: 6 months

    The presence of genes known to represent biochemical functions will be counted and documented

  2. Biosynthetic gene clusters

    Time frame: 6 months

    Groups of genes with known biosynthetic functions and found to be clustered will be counted and documented together in the different samples

Sponsors and collaborators

Lead sponsor

HyGIeaCare, Inc.

Industry

Registry information

Official study title

Pilot Study: Quality Evaluation of Stool Samples Collected for Microbiome Analysis Using the HyGIeaCare Prep

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 11, 2020
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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