Clinical trial NCT04106232: Microbiome Analysis of Constipated Versus Non-constipation Patients
Official title: MIcrobiome Analysis of Chronically Constipated Versus Non-constipated Populations for Detection of Novel Molecular Entities With Therapeutic Potential
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rome IV Functional Constipation
Lead sponsor: HyGIeaCare, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and chronically constipated patients

Brief summary: This study intends to evaluate the microbiome of chronically constipated patients as compared to those with a non-constipated gastrointestinal system.

Detailed description: Biogeographically accurate microbiome sampling using the HyGIeaCare platform and an evolutionary biology informed learning platform will allow an improved discovery of bacterially derived novel molecular entities with therapeutic potential for chronic constipation. This approach intends to enhance our ability to understand the gut microbiome and use it towards developing therapeutic solutions, in comparison to traditional collection methods and taxonomic-based data analysis approaches.

Eligibility criteria: Inclusion Criteria:

1. Patient's age is between 18 and 80 years old.
2. For the healthy population - Indication for age-appropriate colorectal cancer screening colonoscopy
3. Adequate capacity to consent to study
4. Patient does not have any known health issues, except for chronic constipation for the "chronic constipation" population.
5. Patient has not taken antibiotics within the last three (3) months.
6. 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.

Exclusion Criteria:

1. Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation).
2. 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.
3. Current, or recent (within three months) antibiotic usage

   Patient has any of the contraindications listed below:
4. Cardiac: Congestive heart failure (NYHA class III or IV or EF \<50%)
5. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery
6. GU: Renal insufficiency (CC \< 60 ml/min/173m2), cirrhosis with ascites
7. Abdominal surgery within the last 6 months
8. Pregnancy

Primary outcomes:
measure: Identify the presence of microbial substances within stool samples taken from different locations along the colon
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Flowood
country: United States
facility: Hygieacare Center - Flowood
state: Mississippi
city: Cincinnati
country: United States
facility: Hygieacare - Norwood
state: Ohio
city: Norfolk
country: United States
facility: HyGIeaCare Center
state: Virginia
Study officials:
affiliation: Eastern Virginia Medical School
name: David A Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: