Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2026-01-06 @ 2:02 PM
Study NCT ID:
NCT04073927
Status:
UNKNOWN
Last Update Posted:
2019-09-03
First Post:
2019-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D000419', 'term': 'Albuminuria'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'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': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020148', 'term': 'Butyric Acid'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-08-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-29', 'studyFirstSubmitDate': '2019-08-16', 'studyFirstSubmitQcDate': '2019-08-28', 'lastUpdatePostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intestinal inflammation', 'timeFrame': 'Baseline to week 12', 'description': 'Change in concentration of fecal calprotectin determined by ELISA'}], 'secondaryOutcomes': [{'measure': 'Fecal intestinal alkaline phosphatase (IAP)', 'timeFrame': 'Baseline to week 12', 'description': 'Change in IAP activity in feces assessed by colorimetric assay'}, {'measure': 'Short-chain fatty acids (SCFAs)', 'timeFrame': 'Baseline to week 12', 'description': 'Change in acetate, propionate, butyrate and valerate concentration in feces measured by gas chromatography-mass spectrometry'}, {'measure': 'Albuminuria', 'timeFrame': 'Baseline to week 12', 'description': 'Change in urinary albumin-creatinine ratio (UACR)'}, {'measure': 'Kidney function', 'timeFrame': 'Baseline to week 12', 'description': 'Change in eGFR'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 1', 'Albuminuria']}, 'descriptionModule': {'briefSummary': 'The objective is to assess the impact of 12 weeks supplement of sodium-butyrate twice daily or placebo on intestinal inflammation and albuminuria.\n\nA randomized, placebo-controlled, double-blind, two-site trial including 48 patients with type 1 diabetes, albuminuria and intestinal inflammation. Participants will be randomized 1:1 to active treatment or placebo for a period of 12 weeks.\n\nThe primary endpoint is change from baseline to week 12 in intestinal inflammation, measured by fecal calprotectin.', 'detailedDescription': 'In patients with type 1 diabetes, increased intestinal inflammation, reduced gut barrier function and resulting influx of proinflammatory molecules have been described. This might contribute to systemic inflammation and the development of diabetic complications like nephropathy and ischemic heart disease. Interestingly, the gut microbiota is altered in persons with type 1 diabetes, who have less butyrate-producing bacteria. The short-chain fatty acid butyrate improves the intestinal barrier function, and the altered bacterial composition is hypothesized to play a role in the intestinal inflammation. Treatment with butyrate has improved metabolic, colonic and renal function in animal models of chronic kidney disease.\n\nThe aim of the study is to test whether orally ingested sodium butyrate can reduce intestinal inflammation in patients with type 1 diabetes and albuminuria in a randomized, placebo-controlled, double-blind, two-site trial.\n\nPersons with type 1 diabetes and albuminuria are recruited from Steno Diabetes Center Copenhagen (SDCC) and Folkhälsan Research Center, FinnDiane, Helsinki, Finland and screened for intestinal inflammation. 48 participants with intestinal inflammation (fecal calprotectin ≥50 μg/g) are randomized to receive 3.6 g sodium butyrate or placebo for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age with a diagnosis of type 1 diabetes (age at onset \\<40 years; permanent insulin treatment initiated within 1 year of diagnosis)\n2. Albuminuria: UACR \\> 30 mg/g documented in medical history\n3. Calprotectin quick-test result ≥ 50 μg/g (CalDetect 50/200, Preventis) between visit 1 and visit 2.\n4. Able to understand the written patient information and give informed consent\n\nExclusion Criteria:\n\n1. Known inflammatory bowel disease\n2. IBD symptoms due to investigators opinion\n3. Known celiac disease\n4. Existing ostomy\n5. Known rheumatic disorders treated with anti-inflammatory agents\n6. Known hyperthyroidism or hypothyroidism Butyful Protocol - page 12 - Version 3, 25.02.2019\n7. Active immunosuppressant therapy with systemic effect due to investigator's opinion\n8. Current cancer treatment or within five years from baseline (except basal cell skin cancer or squamous cell skin cancer)\n9. eGFR\\<15, dialysis or kidney transplantation\n10. Diagnosis of non-diabetic CKD\n11. Active antibiotic therapy until 30 days ahead of screening\n12. Unable to participate in study procedures\n13. Not able to assess calprotectin by quick test in two attempts\n14. Any clinically significant disorder, except for conditions associated with type 1 DM history, which in the Investigators opinion could interfere with the results of the trial\n15. Pregnancy or lactation\n16. Participation in another intervention study"}, 'identificationModule': {'nctId': 'NCT04073927', 'briefTitle': 'Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'The Butyful Study. Effect of Butyrate on Inflammation and Albuminuria in Patients With Albuminuria, Type 1 Diabetes and Intestinal Inflammation A Randomized, Double-blind, Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'H-18062027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium butyrate', 'description': '3.6 g sodium butyrate. 6 capsules twice daily for 12 weeks.', 'interventionNames': ['Dietary Supplement: Sodium butyrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo. 6 capsules twice daily for 12 weeks.', 'interventionNames': ['Dietary Supplement: Sodium butyrate']}], 'interventions': [{'name': 'Sodium butyrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sodium butyrate Class: Fatty acids Ingredients (100 g): Na-butyrate (50 g), acylglycerol (mono- di, -triacylglycerol; 42 g), bee wax (5 g), sodium alginate E401 (2 g), emulsifier (0.5 g).\n\nThe capsules contain granulated sodium butyrate and are coated with a sodium alginate membrane.', 'armGroupLabels': ['Placebo', 'Sodium butyrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Gentofte Municipality', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Peter Rossing, Professor', 'role': 'CONTACT', 'email': 'peter.rossing@regionh.dk', 'phone': '+45 30193383'}], 'facility': 'Steno Diabetes Center Copenhagen', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}, {'zip': 'FIN-00290', 'city': 'Helsinki', 'status': 'NOT_YET_RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Markku Lehto', 'role': 'CONTACT', 'email': 'markku.lehto@helsinki.fi', 'phone': '+358-40-7715484'}], 'facility': 'Folkhälsan Research Center, FinnDiane', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'centralContacts': [{'name': 'Peter Rossing, Professor', 'role': 'CONTACT', 'email': 'peter.rossing@regionh.dk', 'phone': '+45 30193383'}, {'name': 'Ninna Hahn Tougaard, MD', 'role': 'CONTACT', 'email': 'ninna.hahn.tougaard.01@regionh.dk', 'phone': '+45 29399798'}], 'overallOfficials': [{'name': 'Peter Rossing, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steno Diabetes Center Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Folkhälsan Researech Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, DMsc', 'investigatorFullName': 'Peter Rossing', 'investigatorAffiliation': 'Steno Diabetes Center Copenhagen'}}}}