- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01793831
Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases
Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn&Apos;s Diseases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huijie Zhang, MD, PhD
- Phone Number: 086-25-58509670
- Email: zhjssm@163.com
Study Contact Backup
- Name: Faming Zhang, MD,PHD
- Phone Number: 086-25-58509883
- Email: fzhang@njmu.edu.cn
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210011
- Recruiting
- Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
-
Principal Investigator:
- Faming Zhang
-
Contact:
- Faming Zhang, MD, PhD
- Phone Number: 086-25-58509883
- Email: fzhang@njmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
patients who had been diagnosed with CD through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, patients with inactive and active CD and patients who failed to achieve satisfactory efficacy for CD from the previous therapies.
Exclusion Criteria:
Patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent FMT or WMT before.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fecal microbiota transplantation
Standard fecal microbiota transplantation, once.
|
Standard FMT
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical remission
Time Frame: Up to one year
|
Clinical remission defined as HBI score ≦ 4. The endpoint of follow-up is the time of clinical recurrence.
|
Up to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Costs
Time Frame: Up to one year
|
Social and medical costs
|
Up to one year
|
Adverse events
Time Frame: During FMT and ten years after FMT
|
All possible adverse events:fever,abdominal pain,infectious diseases and others
|
During FMT and ten years after FMT
|
sleep quality
Time Frame: before FMT, 1 month after FMT
|
evaluated by PSQI
|
before FMT, 1 month after FMT
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Aroniadis OC, Brandt LJ. Fecal microbiota transplantation: past, present and future. Curr Opin Gastroenterol. 2013 Jan;29(1):79-84. doi: 10.1097/MOG.0b013e32835a4b3e.
- Damman CJ, Miller SI, Surawicz CM, Zisman TL. The microbiome and inflammatory bowel disease: is there a therapeutic role for fecal microbiota transplantation? Am J Gastroenterol. 2012 Oct;107(10):1452-9. doi: 10.1038/ajg.2012.93.
- Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol Hepatol. 2015 Jan;30(1):51-8. doi: 10.1111/jgh.12727.
- Zhang T, Li P, Wu X, Lu G, Marcella C, Ji X, Ji G, Zhang F. Alterations of Akkermansia muciniphila in the inflammatory bowel disease patients with washed microbiota transplantation. Appl Microbiol Biotechnol. 2020 Dec;104(23):10203-10215. doi: 10.1007/s00253-020-10948-7. Epub 2020 Oct 16.
- Zhang FM, Wang HG, Wang M, Cui BT, Fan ZN, Ji GZ. Fecal microbiota transplantation for severe enterocolonic fistulizing Crohn's disease. World J Gastroenterol. 2013 Nov 7;19(41):7213-6. doi: 10.3748/wjg.v19.i41.7213.
- Zhang T, Xiang J, Cui B, He Z, Li P, Chen H, Xu L, Ji G, Nie Y, Wu K, Fan D, Huang G, Bai J, Zhang F. Cost-effectiveness analysis of fecal microbiota transplantation for inflammatory bowel disease. Oncotarget. 2017 Oct 4;8(51):88894-88903. doi: 10.18632/oncotarget.21491. eCollection 2017 Oct 24.
- He Z, Li P, Zhu J, Cui B, Xu L, Xiang J, Zhang T, Long C, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Multiple fresh fecal microbiota transplants induces and maintains clinical remission in Crohn's disease complicated with inflammatory mass. Sci Rep. 2017 Jul 6;7(1):4753. doi: 10.1038/s41598-017-04984-z.
- Li Q, Ding X, Liu Y, Marcella C, Dai M, Zhang T, Bai J, Xiang L, Wen Q, Cui B, Zhang F. Fecal Microbiota Transplantation is a Promising Switch Therapy for Patients with Prior Failure of Infliximab in Crohn's Disease. Front Pharmacol. 2021 May 17;12:658087. doi: 10.3389/fphar.2021.658087. eCollection 2021.
- Xiang L, Ding X, Li Q, Wu X, Dai M, Long C, He Z, Cui B, Zhang F. Efficacy of faecal microbiota transplantation in Crohn's disease: a new target treatment? Microb Biotechnol. 2020 May;13(3):760-769. doi: 10.1111/1751-7915.13536. Epub 2020 Jan 20.
- Li P, Zhang T, Xiao Y, Tian L, Cui B, Ji G, Liu YY, Zhang F. Timing for the second fecal microbiota transplantation to maintain the long-term benefit from the first treatment for Crohn's disease. Appl Microbiol Biotechnol. 2019 Jan;103(1):349-360. doi: 10.1007/s00253-018-9447-x. Epub 2018 Oct 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMC-CN-121101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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