Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
Study NCT ID:
NCT03917095
Status:
UNKNOWN
Last Update Posted:
2019-05-15
First Post:
2019-04-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of TET Enema in the Treatment of UC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005973', 'term': 'Glutamine'}, {'id': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}, {'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2019-04-12', 'studyFirstSubmitQcDate': '2019-04-12', 'lastUpdatePostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical remission rate', 'timeFrame': '10-days', 'description': 'The frequency of defecation and hematochezia score were both zero'}, {'measure': 'The effective rate', 'timeFrame': '10-days', 'description': 'Part of the total Mayo score was 3 points lower than the baseline'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '10-days', 'description': 'Number of participants with treatment-related adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease', 'Transendoscopic Enteral Tubing', 'Mesalazine', 'Compound Glutamine'], 'conditions': ['Ulcerative Colitis Chronic Mild', 'Ulcerative Colitis Chronic Moderate']}, 'referencesModule': {'references': [{'pmid': '26241537', 'type': 'BACKGROUND', 'citation': 'Crispino P, Pica R, Unim H, Rivera M, Cassieri C, Zippi M, Paoluzi P. Efficacy of mesalazine or beclomethasone dipropionate enema or their combination in patients with distal active ulcerative colitis. Eur Rev Med Pharmacol Sci. 2015 Aug;19(15):2830-7.'}, {'pmid': '29494494', 'type': 'BACKGROUND', 'citation': 'Jeong SY, Im YN, Youm JY, Lee HK, Im SY. l-Glutamine Attenuates DSS-Induced Colitis via Induction of MAPK Phosphatase-1. Nutrients. 2018 Mar 1;10(3):288. doi: 10.3390/nu10030288.'}, {'pmid': '27556065', 'type': 'RESULT', 'citation': 'Peng Z, Xiang J, He Z, Zhang T, Xu L, Cui B, Li P, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Colonic transendoscopic enteral tubing: A novel way of transplanting fecal microbiota. Endosc Int Open. 2016 Jun;4(6):E610-3. doi: 10.1055/s-0042-105205. Epub 2016 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).This clinical trail aims to evaluate the efficacy and safety of Mesalazine and Compound Glutamine enema in the treatment of Ulcerative Colitis through Colonic TET.', 'detailedDescription': 'Enema is a conventional treatment for Ulcerative Colitis(UC). Mesalazine is suitable for the patients with mild to moderate UC.But for the UC with extending lesions, the conventional anema with Mesalazine or other medicine can not very effective.Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).Compared with the conventional enema, which is only used for local administration, the Colonic TET enema can achieve total colonic administration.This study aims to evaluate the efficacy and safety of Colonic TET for UC.Patients in this study will be divided into 5 groups according to certain criteria: the Mesalazine conventional enema group, the Mesalazine TET enema group, the Compound Glutamine conventional enema group, the Compound Glutamine TET enema group, the Mesalazine and Compound Glutamine TET enema group.Each group was given enema for 7 days.The primary outcome measure was the clinical remission efficacy rate in each group. The secondary outcome measure was the safety of TET.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female patients aged between 18 and 65\n2. Patients with chronic relapsed mild to moderate active Ulcerative Colitis(left semicolon or extending colonic lesions)\n3. Patients who can fully understand this study and voluntarily sign an informed consent;\n4. Accept re-examination, follow-up examination and specimen retention in time\n5. Suitable for colonoscopy and colonic TET;\n6. A history of using Mesalazine and Compound Glutamine safely\n\nExclusion Criteria:\n\n1. Anti-tumor necrosis factor or methotrexate was used within the first 8 weeks\n2. Cyclosporine was used within 4 weeks\n3. Antibiotics or probiotics was used within 4 weeks\n4. Patients with risk of toxic megacolon, colon cancer or atypical hyperplasia found in pathology\n5. History of colon surgery\n6. Patients with moderate or severe renal impairment ,abnormal liver function,severe hypertension and cerebrovascular accident\n7. Accompanied by other serious diseases, such as cancer or AIDS, that may hinder their enrollment or affect their survival\n8. Patients with anxiety, depression, mental or legal disabilities\n9. History of suspected or proven alcohol/drug abuse\n10. Patients with explosive, massive bloody stools and severe illness who cannot tolerate the colonoscopy\n11. Patients who are allergic to salicylic acid or aspirin\n12. Patients with food allergies\n13. Patients who are preparing to become pregnant during the study period\n14. Patients considered by the researchers as unsuitable for enrollment'}, 'identificationModule': {'nctId': 'NCT03917095', 'briefTitle': 'The Safety and Efficacy of TET Enema in the Treatment of UC', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Nanjing Medical University'}, 'officialTitle': 'Mesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled Trail', 'orgStudyIdInfo': {'id': 'TET-CN-190408'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mesalazine conventional enema', 'description': 'Participants undergo the conventional enema of Mesalazine Enemas (4g) for one week.', 'interventionNames': ['Drug: Mesalazine']}, {'type': 'EXPERIMENTAL', 'label': 'Mesalazine TET enema', 'description': 'Participants undergo the TET enema of Mesalazine Enemas (4g) for one week.', 'interventionNames': ['Device: The Colonic Transendoscopic enteral Tubing.', 'Drug: Mesalazine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Compound Glutamine conventional enema', 'description': 'Participants undergo the conventional enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.', 'interventionNames': ['Drug: Glutamine']}, {'type': 'EXPERIMENTAL', 'label': 'Compound Glutamine TET enema', 'description': 'Participants undergo the TET enema of Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.', 'interventionNames': ['Device: The Colonic Transendoscopic enteral Tubing.', 'Drug: Glutamine']}, {'type': 'EXPERIMENTAL', 'label': 'Compound Glutamine and Mesalazine TET enema', 'description': 'Participants undergo the TET enema of Mesalazine(4g) and Compound Glutamine (24 tablets of the drug were dissolved in 50ml normal saline) for one week.', 'interventionNames': ['Device: The Colonic Transendoscopic enteral Tubing.', 'Drug: Glutamine', 'Drug: Mesalazine']}], 'interventions': [{'name': 'The Colonic Transendoscopic enteral Tubing.', 'type': 'DEVICE', 'description': 'The medications were infused into the colon through the Colonic Transendoscopic enteral Tubing(TET).', 'armGroupLabels': ['Compound Glutamine TET enema', 'Compound Glutamine and Mesalazine TET enema', 'Mesalazine TET enema']}, {'name': 'Glutamine', 'type': 'DRUG', 'otherNames': ['Glutamine Product'], 'description': 'The medications were infused into the colon', 'armGroupLabels': ['Compound Glutamine TET enema', 'Compound Glutamine and Mesalazine TET enema', 'Compound Glutamine conventional enema']}, {'name': 'Mesalazine', 'type': 'DRUG', 'otherNames': ['Mesalazine Enema Product'], 'description': 'The medications were infused into the colon', 'armGroupLabels': ['Compound Glutamine and Mesalazine TET enema', 'Mesalazine TET enema', 'Mesalazine conventional enema']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210011', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Faming Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-25-58509883'}], 'facility': 'Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Faming Zhang, MD,PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-25-58509883'}], 'overallOfficials': [{'name': 'Faming Zhang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Gastroenterology', 'investigatorFullName': 'Faming Zhang', 'investigatorAffiliation': 'The Second Hospital of Nanjing Medical University'}}}}