Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases
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ClinicalTrials.gov Identifier: NCT01793831 |
Recruitment Status :
Recruiting
First Posted : February 18, 2013
Last Update Posted : September 19, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Diseases Inflammatory Bowel Disease | Procedure: FMT | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn&Apos;s Diseases |
Study Start Date : | November 2012 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 2032 |

Arm | Intervention/treatment |
---|---|
Experimental: Fecal microbiota transplantation
Standard fecal microbiota transplantation, once.
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Procedure: FMT
Standard FMT |
- 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.
- Costs [ Time Frame: Up to one year ]Social and medical costs
- Adverse events [ Time Frame: During FMT and ten years after FMT ]All possible adverse events:fever,abdominal pain,infectious diseases and others

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Ages Eligible for Study: | 6 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Moderate to severe CD define as HBI score > 4.
- Montreal classification: no limitation, except age> 6.
Exclusion Criteria:
- Diagnosis as CD first time or first year.
- No history of using 5-ASA, biological or immunomodulatory therapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793831
Contact: Faming Zhang, MD,PhD | 086-25-58509883 | fzhang@njmu.edu.cn | |
Contact: Huijie Zhang, MD, PhD | 086-25-58509670 | zhjssm@163.com |
China, Jiangsu | |
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University | Recruiting |
Nanjing, Jiangsu, China, 210011 | |
Contact: Faming Zhang, MD, PhD 086-25-58509883 fzhang@njmu.edu.cn | |
Principal Investigator: Faming Zhang |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Faming Zhang, Associate professor, Gastroenterology, The Second Hospital of Nanjing Medical University |
ClinicalTrials.gov Identifier: | NCT01793831 |
Other Study ID Numbers: |
FMC-CN-121101 |
First Posted: | February 18, 2013 Key Record Dates |
Last Update Posted: | September 19, 2018 |
Last Verified: | September 2018 |
Crohn's diseases Inflammatory bowel disease Fecal transplantation Fecal bacteriotherapy Fecal microbiota transplantation |
Crohn Disease Intestinal Diseases Inflammatory Bowel Diseases |
Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |