Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-03-01 @ 12:51 PM
Study NCT ID:
NCT03855956
Status:
COMPLETED
Last Update Posted:
2020-05-14
First Post:
2019-02-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-12', 'studyFirstSubmitDate': '2019-02-25', 'studyFirstSubmitQcDate': '2019-02-26', 'lastUpdatePostDateStruct': {'date': '2020-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in 15N in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.', 'timeFrame': 'Day -3 to Day 28.', 'description': 'Change in 15N in urine in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post-28-day study compound compound consumption.'}], 'secondaryOutcomes': [{'measure': 'Change in 15N in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.', 'timeFrame': 'Day -3 to Day 29.', 'description': 'Change in 15N in stool in response to an amino acid challenge during Baseline (pre-study compound consumption) versus post 28-day study compound consumption.'}, {'measure': 'Change in total nitrogen in blood in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.', 'timeFrame': 'Day -3 to Day 27.', 'description': 'Change in total nitrogen in blood in response to an amino acid challenge during Baseline \\[pre-study compound consumption\\] versus post 28-day study compound consumption.'}, {'measure': 'Change in total nitrogen in urine in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.', 'timeFrame': 'Day -3 to Day 29.', 'description': 'Change in total nitrogen in urine in response to an amino acid challenge during Baseline \\[pre study compound consumption\\] versus post 28-day study compound consumption.'}, {'measure': '. Change in total nitrogen in stool in response to an amino acid challenge, from Baseline to Tracer Period 2, for KB174 compared to maltodextrin.', 'timeFrame': 'Day -3 to Day 29.', 'description': 'Change in total nitrogen in stool in response to an amino acid challenge during Baseline \\[pre study compound consumption\\] versus post 28-day study compound consumption.'}, {'measure': 'Change in ammonia in blood for KB174 compared to Maltodextrin.', 'timeFrame': 'Day -3 to Day 43.', 'description': 'Change in ammonia in blood from Baseline to end of study for KB174 compared to maltodextrin'}, {'measure': 'Change in total urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.', 'timeFrame': 'Day -3 to Day 29.', 'description': 'Change in total urea in urine in response to an amino acid challenge during baseline \\[pre study compound consumption\\] versus post 28-day compound consumption.'}, {'measure': 'Change in 15N-urea in urine in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.', 'timeFrame': 'Day -3 to Day 29.', 'description': 'Change in 15N-urea in urine in response to an amino acid challenge from baseline \\[pre study compound consumption \\] versus post 28-day compound consumption.'}, {'measure': 'Change in 15N-urea in stool in response to an amino acid challenge from baseline to Tracer Period 2, for KB174 compared to maltodextrin.', 'timeFrame': 'Day -3 to Day 29.', 'description': 'Change in 15N-urea in stool in response to an amino acid challenge from baseline \\[pre study compound consumption \\] versus post 28-day compound consumption.'}, {'measure': 'Incidence of treatment-emergent adverse events from baseline to end of study.', 'timeFrame': 'Day -7 through Day 43 visit.'}, {'measure': 'Incidence of serious adverse events from base baseline to end of study.', 'timeFrame': 'Day -7 through Day 43.'}, {'measure': 'Change in Gastrointestinal Tolerability Questionnaire (GITQ) through the collection of daily patient questionnaires.', 'timeFrame': 'Day -7 through Day 43.', 'description': 'Evaluate the effect of KB195 on self-report questionnaires including the Gastrointestinal Tolerability Questionnaire, an assessment of the frequency and severity of GI symptoms, e.g., gas, abdominal pain, calculated on a scale from 0 (None/Not applicable) to a maximum score of 60 (Severe/Much more than usual) for all questions.'}, {'measure': 'Change in Bristol Stool Scale (BSS) through the collection of daily patient questionnaires', 'timeFrame': 'Day -7 through Day 43.', 'description': 'Evaluate the effect of KB195 on self-report questionnaires including the Bristol Stool Scale, an assessment of stool consistency on a scale from 1 (separate hard lumps, like nuts, hard to pass) through 7 (watery, no solid pieces, entirely liquid).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Early Cirrhosis']}, 'descriptionModule': {'briefSummary': 'This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut microbiome structure and function in subjects with well-compensated cirrhosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be able and willing to provide written informed consent\n* Be male or female, 18 to 70 years of age (inclusive)\n* Have a body mass index (BMI) ≥ 20.0 and \\< 40.0 kg/m2\n* Well-compensated cirrhosis\n* Negative for hepatocellular carcinoma (HCC)\n* Adequate safety laboratory values at Screening.\n* Be willing to maintain a stable diet throughout the course of the study, and willing to continue usual exercise routine\n* If of child bearing potential must follow contraceptive requirements of the protocol\n* Have reliable internet access\n\nExclusion Criteria:\n\n* Have evidence of decompensated liver disease.\n* History or active GI disease.\n* Prior solid organ transplantation, including liver transplantation or on liver transplant waiting list.\n* Subject has a history of drug and/or alcohol abuse.'}, 'identificationModule': {'nctId': 'NCT03855956', 'briefTitle': 'Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kaleido Biosciences'}, 'officialTitle': 'A Randomized, Double-blind, Controlled, Clinical Food Study to Evaluate the Effect of KB174 Compared to an Easily Digestible Polysaccharide on Function and Structure of the Gut Microbiome in Subjects With Well-compensated Cirrhosis', 'orgStudyIdInfo': {'id': 'K022-118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KB174 Arm', 'description': 'KB174 is a novel mixture of oligosaccharides.', 'interventionNames': ['Other: KB174']}, {'type': 'OTHER', 'label': 'Maltodextrin Arm', 'description': 'Maltodextrin is a commercially available easily digestible polysaccharide.', 'interventionNames': ['Other: Maltodextrin']}], 'interventions': [{'name': 'KB174', 'type': 'OTHER', 'description': 'KB174 is a novel mixture of oligosaccharides.', 'armGroupLabels': ['KB174 Arm']}, {'name': 'Maltodextrin', 'type': 'OTHER', 'description': 'Maltodextrin is a commercially available easily digestible polysaccharide.', 'armGroupLabels': ['Maltodextrin Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33147', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Pharma CR, LLC', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Marquez Clinical Site Partners, LLC Florida Premier Research Institute', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '71201', 'city': 'Monroe', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Delta Research Partners', 'geoPoint': {'lat': 32.50931, 'lon': -92.1193}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaleido Biosciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}