Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-31 @ 11:29 AM
Study NCT ID:
NCT04259060
Status:
WITHDRAWN
Last Update Posted:
2024-04-22
First Post:
2020-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative Colitis Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006879', 'term': 'Hydroxocobalamin'}, {'id': 'D002087', 'term': 'Butyrates'}], 'ancestors': [{'id': 'D014805', 'term': 'Vitamin B 12'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Decision to pursue a smaller scale pilot study instead', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-19', 'studyFirstSubmitDate': '2020-01-27', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline fecal calprotectin at week 4', 'timeFrame': 'At baseline and at week 4', 'description': 'Proportion of patients with reductions in fecal calprotectin'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events (AE) as assessed by Common Terminology Criteria for Adverse Events (CTCAE)', 'timeFrame': 'Up to 4 weeks', 'description': 'CTCAE are a set of criteria for the standardized classification of adverse effects of drugs used in clinical trials. It uses a range of grades from 1 to 5, where 1 is mild and 5 is life-threatening.The number of AE and grade of each AE will be measured for the duration of the trial.'}, {'measure': 'Clinical Symptoms assessed by Simple Clinical Colitis Activity Index (SCCAI)', 'timeFrame': 'Up to 4 weeks', 'description': 'The SCCAI is an index to measure disease activity in patients with UC. SCCAI will be used throughout the trial to measure clinical UC symptoms of participants.'}], 'secondaryOutcomes': [{'measure': 'Assessment of urinary and plasma nitrite, nitrate levels and nitrosothiol levels', 'timeFrame': 'At week 1-2 and at week 4', 'description': 'Comparison of levels at baseline to week 1-2 and week 4'}, {'measure': 'Normalization of fecal calprotectin below the upper limit of normal', 'timeFrame': 'At the end of week 4', 'description': 'Assessment in number of patients whose fecal calprotectin normalizes'}, {'measure': 'Reduction of Mayo Score (Phase 2)', 'timeFrame': 'At the end of week 4', 'description': 'Proportion of patients with a reduction in Mayo Score'}, {'measure': 'Correlation between urinary and plasma nitrite, nitrate or nitrosothiol levels and fecal calprotectin', 'timeFrame': 'Up to 4 weeks', 'description': 'Comparison of biochemical levels with calprotectin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis', 'Inflammatory Bowel Disease', 'Butyrate', 'Hydroxocobalamin'], 'conditions': ['Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'This is a 4-week pilot, multicenter, randomized, double-blinded placebo controlled trial of hydroxocobalamin and butyrate in ulcerative colitis (UC) that will occur in two phases. The main objectives of this study are to determine the capacity of hydroxocobalamin and butyrate to reduce calprotectin in those with inflammatory disease in UC to determine the safety and preferential dose of hydroxocobalamin with butyrate in UC.', 'detailedDescription': 'The goal of this study is to determine the preferable dose of hydroxocobalamin in a 4-week pilot study in patients with UC and determine if this approach can reduce stool calprotectin. Before going forward with a larger efficacy trial, the investigators are first aiming to determine if the supplements/medications we are proposing to use are sufficient to reduce a biomarker. Consequently, this study will look at a more easily measurable biomarker to provide evidence that the dosing is sufficient.\n\nThis pilot study will be conducted to assess preferable dose of hydroxocobalamin based on reduction of calprotectin. The investigators aim to determine if this reduction is sustained over time and is correlated to changes in clinical disease activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18-75\n2. Ability to give consent\n3. Patients with a confirmed diagnosis of UC for \\> 3 months\n4. History of \\> 15 cm of colonic involvement as confirmed by colonoscopy\n5. Disease activity based on calprotectin \\> 200\n6. Allowed medications: mesalamine and sulfasalazine\n7. Partial Mayo score of \\> 4 for phase one or a total Mayo score \\> 5 in phase 2\n8. Patients with primary sclerosing cholangitis are eligible to enroll\n\nExclusion Criteria:\n\n1. History of uncontrolled hypertension with a systolic BP \\> 140 and a systolic BP \\> 90\n2. Chronic kidney disease as defined by a GFR \\<60mL/min\n3. Impaired hepatic function (transaminases elevated \\> 2.5 x ULN) unless due to PSC\n4. Evidence of C. difficile - negative test result within 1 month is acceptable to confirm\n5. Infectious Colitis or drug induced colitis\n6. Crohn's Disease or Indeterminate colitis\n7. Decompensated liver disease\n8. Patients who are pregnant or breastfeeding\n9. Prohibited medications: Vitamin C, prednisone, immune modulators (including but not limited to azathioprine, 6-mercaptopurine, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10 and interleukin-11) and anti-TNF agents within the past six weeks\n10. Use of rectal therapies\n11. Patients who have a confirmed malignancy or cancer within 5 years\n12. Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial\n13. Congenital or acquired immunodeficiencies\n14. Other comorbidities including: Diabetes mellitus, systemic lupus\n15. Patients with a history of kidney stones\n16. Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease\n17. High likelihood of colectomy in the next 2 months"}, 'identificationModule': {'nctId': 'NCT04259060', 'acronym': 'HARBOUR', 'briefTitle': 'Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative Colitis Remission', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative', 'orgStudyIdInfo': {'id': '2019P003412'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hydroxocobalamin with Butyrate', 'description': 'Subjects enrolled will take hydroxocobalamin capsules twice daily for 4 weeks. All subjects will take an oral butyrate dose of 120 mg twice daily for 4 weeks.', 'interventionNames': ['Drug: Hydroxocobalamin with Butyrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo with Butyrate', 'description': 'Subjects enrolled will take placebo capsules twice daily for 4 weeks. All subjects will take an oral butyrate dose of 120 mg twice daily for 4 weeks.', 'interventionNames': ['Drug: Placebo with Butyrate']}], 'interventions': [{'name': 'Hydroxocobalamin with Butyrate', 'type': 'DRUG', 'description': 'In phase 1, patients will take hydroxocobalamin at 1g daily for four weeks. This will be in the form of 1 500mg capsule twice a day. Butyrate will be 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day.\n\nIn phase 2, the dose of hydroxocobalamin will be increased to 2g daily (1g twice a day) for four weeks pending FDA approval. Butyrate will remain at 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day. Patients will undergo flexible sigmoidoscopy at baseline and at week four in phase 2.', 'armGroupLabels': ['Hydroxocobalamin with Butyrate']}, {'name': 'Placebo with Butyrate', 'type': 'DRUG', 'description': 'In phase 1, patients will take 1 placebo capsule twice a day. Butyrate will be taken at 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day.\n\nIn phase 2, patients will take 2 placebo capsules twice a day, along with butyrate at 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day.', 'armGroupLabels': ['Placebo with Butyrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02467', 'city': 'Chestnut Hill', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.33065, 'lon': -71.16616}}], 'overallOfficials': [{'name': 'Joshua R Korzenik, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joshua Korzenik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Director, Crohn's and Colitis Center", 'investigatorFullName': 'Joshua Korzenik', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}