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Microbiome Analysis of Constipated Versus Non-Constipated Patients

November 5, 2019

Overview

This study uses HyGieaCare and biological microbiome therapy in an attempt to provide relief for people with chronic constipation. This platform and form of therapy is administered to help researchers better understand the gut microbiome.

 

Study Information

The microbiome and HyGieaCare therapies will be given to subjects with constipation and without constipation. This is to determine if the therapies are effective or just serve as a placebo, with no medicinal benefit. 

 

Inclusion Criteria

  • All sexes, ages 18 to 80 years old.
  • For the healthy population – Indication for age-appropriate colorectal cancer screening colonoscopy
  • Able to provide to consent to study
  • For the “chronic constipation” population – Patient does not have any known health issues, except for chronic constipation
  • Have not taken antibiotics within the last three (3) months.
  • For chronically constipated patients – More than 3  months of symptomatic constipation with first occurrence over 6 months ago.

 

Exclusion Criteria

  • Functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation)
  • Any condition that, in the opinion of the investigator, may negatively 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
  • Congestive heart failure (NYHA class III or IV or EF <50%)
  • Intestinal perforation
  • Carcinoma of the rectum
  • Fissures or fistula
  • Severe hemorrhoids
  • Abdominal hernia
  • Recent colon or rectal surgery
  • Abdominal surgery
  • Renal insufficiency (CC < 60 ml/min/173m2)
  • Cirrhosis with ascites
  • Abdominal surgery within the last 6 months
  • Pregnant

 

Locations

You may participate in this study at HyGieaCare Center in Norfolk, Virgina, 23502. If you any questions feel free to contact April Fenner, RN at 214-509-6855 or at april.fenner@hygleacare.com.

 

Sponsors/Collaborators

This study is sponsored by HyGieaCare, Inc. with David A. Johnson, MD as the Principal Investigator.

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