Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2025-12-26 @ 9:47 PM
Study NCT ID:
NCT03348592
Status:
UNKNOWN
Last Update Posted:
2017-11-21
First Post:
2017-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Microbiome and p-Inulin in CKD - TarGut CKD Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-11-22', 'releaseDate': '2022-10-25'}, {'resetDate': '2023-02-22', 'releaseDate': '2023-01-25'}, {'releaseDate': '2023-03-17', 'unreleaseDate': '2023-03-30'}, {'resetDate': '2024-05-16', 'releaseDate': '2024-04-22'}, {'resetDate': '2025-10-21', 'releaseDate': '2025-10-06'}, {'resetDate': '2025-12-09', 'releaseDate': '2025-11-18'}], 'estimatedResultsFirstSubmitDate': '2022-10-25'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-28', 'size': 733619, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-10-18T13:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is a 28 week study. Participants take no treatment for 8 weeks, followed by 12 weeks on the pre-biotic p-inulin, followed by no treatment for 8 weeks. The treatment arms are no treatment and the pre-biotic p-inulin. Inulin is derived from chicory root fiber.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-15', 'studyFirstSubmitDate': '2017-10-31', 'studyFirstSubmitQcDate': '2017-11-15', 'lastUpdatePostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbial composition of stool', 'timeFrame': 'Stool is collected weekly for 28 weeks', 'description': 'Microbial taxonomy will be assigned using Ribosomal Database Project (RDP) for 16S, augmented by analysis of specific sequences using BLAST. The 16S tag sequences will be collected into operational taxonomic units (OTUs) with 97% sequence identity.'}, {'measure': 'Adherence to p inulin prescription', 'timeFrame': 'Packets are counted every four weeks during the 12 weeks when the patient is taking p inulin', 'description': 'Proportion of packets taken vs packets prescribed by packet count'}], 'secondaryOutcomes': [{'measure': 'butyrate', 'timeFrame': 'Collected weekly for 28 weeks', 'description': 'captured by untargeted metabolomics, short chain fatty acid in stool blood and urine'}, {'measure': 'propionate', 'timeFrame': 'Collected weekly for 28 weeks', 'description': 'captured by untargeted metabolomics, short chain fatty acid in stool blood and urine'}, {'measure': 'acetate', 'timeFrame': 'Collected weekly for 28 weeks', 'description': 'captured by untargeted metabolomics, short chain fatty acid measured in stool blood and urine'}, {'measure': 'Trimethylamine N oxide', 'timeFrame': 'Collected weekly for 28 weeks', 'description': 'captured by untargeted metabolomics in stool blood and urine'}, {'measure': 'Choline', 'timeFrame': 'Collected weekly for 28 weeks', 'description': 'captured by untargeted metabolomics in stool blood and urine'}, {'measure': 'Betaine', 'timeFrame': 'Collected weekly for 28 weeks', 'description': 'captured by untargeted metabolomics in stool blood and urine'}, {'measure': 'Indoles', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'Indoxyl sulfate Indoxyl glucuronide 5-hydroxyindole Indole-3-prioonic acid Indole-3-acetic acid captured by untargeted metabolomics in stool blood and urine'}, {'measure': 'Phenols', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'p-cresol sulfate p-Cresol glucuronide Phenyl sulfate Phenyl glucuronide α-N-phenylacetyl-L-glutamine Phenylpropionylglycine Hippuric acid 4-hydroxybenzoate Phenylacetylglycine\n\n\\* captured by untargeted metabolomics and quantitated by targeted metabolomics in stool blood urine'}, {'measure': 'polyamines', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'captured by untargeted metabolomics in stool blood and urine'}, {'measure': 'metabolites of urea and creatinine metabolism', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'captured by untargeted metabolomics in stool blood and urine'}, {'measure': 'Allantoin', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'captured by untargeted metabolomics in stool blood and urine'}, {'measure': 'Fructose', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'captured by untargeted metabolomics in stool blood and urine'}, {'measure': 'Cytokines', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'IL-1β IL-2 IL-4 IL-6 IL-10 IL-17 IL-22 TNFα measured by standard ELISA in stool'}, {'measure': 'endotoxin', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'measured by standard ELISA in stool'}, {'measure': 'Myeloperoxdase (MPO)', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'measured by standard ELISA in stool'}, {'measure': 'hsCRP', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'measured by standard ELISA in stool'}, {'measure': 'HMGB1', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'measured by standard ELISA in stool'}, {'measure': 'TNF-R1', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'measured by standard ELISA in stool'}, {'measure': 'TNF-R2', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'measured by standard ELISA in stool'}, {'measure': 'Lipopolysaccharide binding protein (LBP)', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'measured by standard ELISA in stool'}, {'measure': 'sCD14', 'timeFrame': 'collected weekly for 28 weeks', 'description': 'measured by standard ELISA in stool'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Microbiome, p-inulin'], 'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'The purpose of this Phase 1, 3-period crossover with repeated measures feasibility study is to characterize the gut microbiome of individuals with chronic kidney disease, and to explore effects of p-inulin on the gut microbiome. The nature of the study will provide information about the feasibility of stool sample collection for future multicenter studies of the gut microbiome.', 'detailedDescription': 'The overarching hypothesis motivating this exploratory study of variability is that treatment with oligofructose-enriched inulin (p-inulin) will alter the composition and/or function of the gut microbiome, and thereby reduce the generation of gut-derived uremic toxins, improve gut barrier function and attenuate systemic inflammation in CKD patients. In order to design a future clinical trial the following parameters from CKD subjects are needed:\n\n1. Intra-patient variability in the composition and function of the gut microbiome\n2. Inter-patient variability in the composition and function of the gut microbiome\n3. Impact of p-inulin on the composition and function of the gut microbiome\n4. Tolerability of p-inulin administration\n5. Feasibility of collecting stool samples in this patient population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects with eGFR 15.0 to 50.0 ml/min/1.73 m2 as estimated by the CKD-EPI equation\n2. Albuminuria greater than 300 mg/g creatinine (by spot urine test) if eGFR is ≥45 ml/min/1.73 m2\n3. Age ≥ 18 years\n4. For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug. See Section 4.2.1 for definition of childbearing potential and acceptable methods of birth control\n5. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Use of pre- or pro-biotics during the past 2 months\n2. Consumption of probiotic yogurt during the past 2 weeks\n3. Use of antibiotics within the past 3 months if the patient received a single course of antibiotic. If the patient received more than one course of antibiotic treatment, we will wait for 6 months prior to inclusion.\n4. Presence of HIV infection, chronic wound infection and osteomyelitis\n5. Presence of or treatment for periodontal infection\n6. Inflammatory bowel disease, chronic diarrhea, current C. difficile infection\n7. Cirrhosis or chronic active hepatitis\n8. Treatment with immunosuppressive medications in the past 6 months or more than a week of treatment with prednisone \\>10 mg in the last 3 months\n9. Treatment with proton pump inhibitors within the last one month\n10. Anticipated initiation of dialysis or kidney transplant within 9 months\n11. Acute on chronic kidney disease\n12. Expected survival \\< 9 months Do not disclose or use except as authorized by the Pilot Clinical Trials in CKD Consortium.\n13. Pregnancy, anticipated pregnancy, or breastfeeding\n14. Incarceration\n15. Participation in another intervention study\n16. Severe anemia defined as hemoglobin \\<9.0 g/dl any time during the last 3 months\n17. Patients in whom frequent blood sampling may be difficult'}, 'identificationModule': {'nctId': 'NCT03348592', 'acronym': 'TarGut', 'briefTitle': 'Gut Microbiome and p-Inulin in CKD - TarGut CKD Study', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Gut Microbiome and p-Inulin in CKD TarGut CKD Study', 'orgStudyIdInfo': {'id': 'DK099877-T'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oligofructose-enriched inulin (p-inulin)', 'description': 'Participants are on no treatment for 8 weeks, then the pre-biotic p-inulin for 12 weeks, then no treatment for 8 weeks. Inulin is derived from chicory root fiber. The dose is 16 grams of p-inulin powder per day.', 'interventionNames': ['Dietary Supplement: Oligofructose-enriched inulin (p-inulin)', 'Other: No treatment']}], 'interventions': [{'name': 'Oligofructose-enriched inulin (p-inulin)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Oligofructose-enriched inulin (p-inulin)']}, {'name': 'No treatment', 'type': 'OTHER', 'description': 'Patients do not take a supplement during the first 8 weeks or the last 8 weeks of the study.', 'armGroupLabels': ['Oligofructose-enriched inulin (p-inulin)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'The George Washington University Medical Faculty Associates', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Kevin C. Abbott, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, {'name': 'Jennifer J. Gassman, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Linda F. Fried, MD, MPH', 'role': 'STUDY_CHAIR', 'affiliation': 'VA Pittsburgh Healthcare System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'George Washington University', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator - Data Coordinating Center', 'investigatorFullName': 'Jennifer Gassman', 'investigatorAffiliation': 'The Cleveland Clinic'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-10-25', 'type': 'RELEASE'}, {'date': '2022-11-22', 'type': 'RESET'}, {'date': '2023-01-25', 'type': 'RELEASE'}, {'date': '2023-02-22', 'type': 'RESET'}, {'date': '2023-03-17', 'type': 'RELEASE'}, {'date': '2023-03-30', 'type': 'UNRELEASE'}, {'date': '2024-04-22', 'type': 'RELEASE'}, {'date': '2024-05-16', 'type': 'RESET'}, {'date': '2025-10-06', 'type': 'RELEASE'}, {'date': '2025-10-21', 'type': 'RESET'}, {'date': '2025-11-18', 'type': 'RELEASE'}, {'date': '2025-12-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jennifer Gassman, PhD, Principal Investigator - Data Coordinating Center, The Cleveland Clinic'}}}}