Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-04-02 @ 9:15 AM
Study NCT ID:
NCT04106232
Status:
COMPLETED
Last Update Posted:
2023-04-27
First Post:
2019-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiome Analysis of Constipated Versus Non-constipation Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Overall, we expect to enroll 20 subjects. Each volunteer or patient will provide a traditional stool sample ("spot sample"), collected in their home. During the HyGIeaCare prep, we will collect up to 3 samples from each patient (unless we will need an "initial" one from the constipated population).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify the presence of microbial substances within stool samples taken from different locations along the colon', 'timeFrame': '12 months', 'description': 'Finding novel molecular entities with therapeutic potential for chronic constipation using the unique HyGIeaCare approach for constipation relief and collection of fecal material for analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rome IV Functional Constipation']}, 'descriptionModule': {'briefSummary': 'This study intends to evaluate the microbiome of chronically constipated patients as compared to those with a non-constipated gastrointestinal system.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteers and chronically constipated patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient\'s age is between 18 and 80 years old.\n2. For the healthy population - Indication for age-appropriate colorectal cancer screening colonoscopy\n3. Adequate capacity to consent to study\n4. Patient does not have any known health issues, except for chronic constipation for the "chronic constipation" population.\n5. Patient has not taken antibiotics within the last three (3) months.\n6. For chronically constipated patients - \\>3 months of symptomatic constipation with first onset of constipation more than 6 months ago.\n\nFor chronically constipated patients - Diagnosis of functional constipation by Modified Rome IV Diagnostic Criteria.\n\nExclusion Criteria:\n\n1. Patient has functional bowel disorders characterized by alternating bowel habits (diarrhea/constipation).\n2. 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.\n3. Current, or recent (within three months) antibiotic usage\n\n Patient has any of the contraindications listed below:\n4. Cardiac: Congestive heart failure (NYHA class III or IV or EF \\<50%)\n5. GI: Intestinal perforation, carcinoma of the rectum, fissures or fistula, severe hemorrhoids, abdominal hernia, recent colon or rectal surgery, or abdominal surgery\n6. GU: Renal insufficiency (CC \\< 60 ml/min/173m2), cirrhosis with ascites\n7. Abdominal surgery within the last 6 months\n8. Pregnancy'}, 'identificationModule': {'nctId': 'NCT04106232', 'briefTitle': 'Microbiome Analysis of Constipated Versus Non-constipation Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'HyGIeaCare, Inc.'}, 'officialTitle': 'MIcrobiome Analysis of Chronically Constipated Versus Non-constipated Populations for Detection of Novel Molecular Entities With Therapeutic Potential', 'orgStudyIdInfo': {'id': 'HGP-0008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No change in procedure except for specimen collection throughout procedure', 'type': 'OTHER', 'description': 'Stool specimens will be taken before and during the HyGIeaCare procedure. Microbiome comparisons will be made across all specimens'}]}, 'contactsLocationsModule': {'locations': [{'zip': '39232', 'city': 'Flowood', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Hygieacare Center - Flowood', 'geoPoint': {'lat': 32.30959, 'lon': -90.13898}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hygieacare - Norwood', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'HyGIeaCare Center', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'David A Johnson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Virginia Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Outcomes will be used internally for future studies.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HyGIeaCare, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}