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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
NCT01790061 |
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Date of registration:
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09/02/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
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Scientific title:
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Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT01790061 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Faming Zhang, MD, PhD |
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Address:
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Telephone:
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086-25-58509883 |
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Email:
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fzhang@njmu.edu.cn |
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Affiliation:
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Name:
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Faming Zhang, MD,PhD |
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Address:
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Telephone:
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086-25-58509883 |
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Email:
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fzhang@njmu.edu.cn |
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Affiliation:
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Name:
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Huijie Zhang, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Second Afiliated Hospital of Nanjing Medical University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Patients who had been diagnosed with UC through a combination of typical clinical symptoms,
endoscopy, and histological criteria for at least 3 months, and patients who failed to
achieve satisfactory efficacy for UC 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.
Age minimum:
6 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bacteria
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Inflammatory Bowel Disease
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Ulcerative Colitis
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Microbiota
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Fecal Microbiota Transplantation
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Intervention(s)
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Procedure: Standardized FMT
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Drug: Traditional treatments
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Primary Outcome(s)
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Efficacy of FMT
[Time Frame: On year]
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Secondary Outcome(s)
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fatigue evaluated by the Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F)
[Time Frame: before FMT, 1 month and 12 weeks after FMT]
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anxiety and depression evaluated by the Hospital Anxiety and Depression Scale (HADS)
[Time Frame: before FMT, 1 month and 12 weeks after FMT]
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sleep quality evaluated by the Insomnia Severity Index (ISI)
[Time Frame: before FMT, 1 month and 12 weeks after FMT]
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sleep quality evaluated by the Pittsburgh Sleep Quality Index (PSQI)
[Time Frame: before FMT, 1 month and 12 weeks after FMT]
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Adverse events
[Time Frame: Ten years]
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Secondary ID(s)
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FMT-CN-121123
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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