Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 3:06 PM
Study NCT ID:
NCT06730451
Status:
RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microbiota Transplantation in Solid Organ Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Fecal, urine, and blood samples before and after intervention'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2024-12-06', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stool frequency and consistency', 'timeFrame': 'Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT', 'description': 'Stool frequency ≥3 times per day was considered as diarrhea. Higher frequency represents more severe diarrhea. Stool consistency will be evaluated according to the Bristol Stool Form Scale ranging from type 1 - type 7. Type 1 and 2 indicate constipation, Type 3 and type 4 indicate normal defecation, Type 5, 6 and 7 indicate diarrhea.'}, {'measure': 'Gastrointestinal Symptom Rating Scale (GSRS)', 'timeFrame': 'Baseline, 1-week, 2-week, 1-month, 2-month, 3-month post WMT', 'description': 'GSRS is a 15-item instrument designed to assess the symptoms associated with common GI disorders. The GSRS consists of 5 subscales (reflux, diarrhea, constipation, abdominal pain, and indigestion) producing a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).'}], 'secondaryOutcomes': [{'measure': 'The changes in gut microbiota composition by sequencing faecal metagenome', 'timeFrame': 'Baseline, 1-month, 3-month post WMT', 'description': 'The changes in gut microbe composition before and after WMT were evaluated by sequencing faecal metagenome.'}, {'measure': 'Quality of life by 36-Item Short Form Health Survey(SF-36)', 'timeFrame': 'Baseline, 1-month, 3-month post WMT', 'description': 'SF-36 is a 36-item questionnaire to assess the impact of disease on daily life. The SF-36 consists of 8 subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health) ranging from 0 to 100. Lower scores represent more dysfunction.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid Organ Transplant Complications', 'Washed microbiota transplantation', 'Fecal microbiota transplantation', 'Diarrhea'], 'conditions': ['Solid Organ Transplant Complications']}, 'referencesModule': {'references': [{'pmid': '34510717', 'type': 'BACKGROUND', 'citation': 'Gabarre P, Loens C, Tamzali Y, Barrou B, Jaisser F, Tourret J. Immunosuppressive therapy after solid organ transplantation and the gut microbiota: Bidirectional interactions with clinical consequences. Am J Transplant. 2022 Apr;22(4):1014-1030. doi: 10.1111/ajt.16836. Epub 2021 Oct 15.'}, {'pmid': '29920927', 'type': 'BACKGROUND', 'citation': 'Lee JR, Magruder M, Zhang L, Westblade LF, Satlin MJ, Robertson A, Edusei E, Crawford C, Ling L, Taur Y, Schluter J, Lubetzky M, Dadhania D, Pamer E, Suthanthiran M. Gut microbiota dysbiosis and diarrhea in kidney transplant recipients. Am J Transplant. 2019 Feb;19(2):488-500. doi: 10.1111/ajt.14974. Epub 2018 Jul 21.'}, {'pmid': '36044594', 'type': 'BACKGROUND', 'citation': 'Swarte JC, Li Y, Hu S, Bjork JR, Gacesa R, Vich Vila A, Douwes RM, Collij V, Kurilshikov A, Post A, Klaassen MAY, Eisenga MF, Gomes-Neto AW, Kremer D, Jansen BH, Knobbe TJ, Berger SP, Sanders JF, Heiner-Fokkema MR, Porte RJ, Cuperus FJC, de Meijer VE, Wijmenga C, Festen EAM, Zhernakova A, Fu J, Harmsen HJM, Blokzijl H, Bakker SJL, Weersma RK. Gut microbiome dysbiosis is associated with increased mortality after solid organ transplantation. Sci Transl Med. 2022 Aug 31;14(660):eabn7566. doi: 10.1126/scitranslmed.abn7566. Epub 2022 Aug 31.'}, {'pmid': '30085388', 'type': 'BACKGROUND', 'citation': 'Cheng YW, Phelps E, Ganapini V, Khan N, Ouyang F, Xu H, Khanna S, Tariq R, Friedman-Moraco RJ, Woodworth MH, Dhere T, Kraft CS, Kao D, Smith J, Le L, El-Nachef N, Kaur N, Kowsika S, Ehrlich A, Smith M, Safdar N, Misch EA, Allegretti JR, Flynn A, Kassam Z, Sharfuddin A, Vuppalanchi R, Fischer M. Fecal microbiota transplantation for the treatment of recurrent and severe Clostridium difficile infection in solid organ transplant recipients: A multicenter experience. Am J Transplant. 2019 Feb;19(2):501-511. doi: 10.1111/ajt.15058. Epub 2018 Aug 31.'}, {'pmid': '32024079', 'type': 'BACKGROUND', 'citation': 'Swarte JC, Douwes RM, Hu S, Vich Vila A, Eisenga MF, van Londen M, Gomes-Neto AW, Weersma RK, Harmsen HJM, Bakker SJL. Characteristics and Dysbiosis of the Gut Microbiome in Renal Transplant Recipients. J Clin Med. 2020 Feb 1;9(2):386. doi: 10.3390/jcm9020386.'}, {'pmid': '31919742', 'type': 'BACKGROUND', 'citation': 'Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.'}, {'pmid': '35576458', 'type': 'BACKGROUND', 'citation': 'Lu G, Wang W, Li P, Wen Q, Cui B, Zhang F. Washed preparation of faecal microbiota changes the transplantation related safety, quantitative method and delivery. Microb Biotechnol. 2022 Sep;15(9):2439-2449. doi: 10.1111/1751-7915.14074. Epub 2022 May 16.'}]}, 'descriptionModule': {'briefSummary': 'Solid organ transplantation (SOT), an alternative therapy for end-stage diseases, offers increased longevity and better quantity of life. Posttransplant complications such as gastrointestinal symptoms, infection, and graft rejection increase risk with graft failure and death. However, the treatment of abovementioned complications remains unsatisfactory. Gut dysbiosis has been reported in patients with SOT, especially in patients with posttransplant complications. Recipients are more susceptible to gut dysbiosis as long-term use of immunosuppressants, antibiotics and corticosteroids. Restoring gut microbiome may be a promising therapy for posttransplant complications. Washed microbiota transplantation (WMT) is a newly improved methodology of fecal microbiota transplantation based on automatic facilities, washing process and a new delivery routine. In this study, investigators aimed to evaluate the efficacy and safety of WMT for postoperative complications in SOT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Solid organ transplantation recipients receiving WMT will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. solid organ transplantation recipients;\n2. suffering from gastrointestinal symptoms (e.g. diarrhea, constipation, abdominal pian), infection (e.g. Clostridium difficile) post-transplantation and so on;\n3. is willing to undergo WMT and provide written informed consent.\n\nExclusion Criteria:\n\n1. patients with history of gastrointestinal diseases or homologous pathogen infection pre-transplant;\n2. pregnant or lactating females;\n3. expected survival\\<1 months;\n4. unable to understand the purpose of the study, communicate effectively with investigators and comply with all study procedures;\n5. follow up less than 1-month post-WMT;\n6. other conditions judged by investigators not suitable for study participation.'}, 'identificationModule': {'nctId': 'NCT06730451', 'briefTitle': 'Microbiota Transplantation in Solid Organ Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Nanjing Medical University'}, 'officialTitle': 'Washed Microbiota Transplantation for Postoperative Complications in Solid Organ Transplantation', 'orgStudyIdInfo': {'id': 'WMT-SOT complications'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Washed Microbiota Transplantation', 'type': 'OTHER', 'description': 'Washed microbiota suspension delivered through mild-gut and lower-gut'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Faming Zhang, PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '025-25-58509883'}], 'facility': 'The Second Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Faming Zhang, PhD', 'role': 'CONTACT', 'email': 'fzhang@njmu.edu.cn', 'phone': '086-25-58509883'}], 'overallOfficials': [{'name': 'Faming Zhang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Hospital of Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Chinese fmtBank', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Gastroenterology', 'investigatorFullName': 'Faming Zhang', 'investigatorAffiliation': 'The Second Hospital of Nanjing Medical University'}}}}