Fecal Microbiota Transplantation for Ulcerative Colitis (FMTFUC)
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|ClinicalTrials.gov Identifier: NCT03016780|
Recruitment Status : Unknown
Verified December 2016 by First Affiliated Hospital of Chengdu Medical College.
Recruitment status was: Recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Intestinal Bacteria Flora Disturbance Fecal Microbiota Transplantation||Other: Fecal Microbiota Transplantation Other: Normal Saline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of The Effect of Fecal Microbiota Transplantation on Ulcerative Colitis and Its Mechanism|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2019|
Active Comparator: Treatment in part 1
Fecal microbiota transplantation and traditional treatments will be used in patients with ulcerative colitis in part 1.
Other: Fecal Microbiota Transplantation
Fecal microbiota transplantation and the traditional treatments for ulcerative colitis in part 1.
Other Name: Fecal Microbiota Transplantation(FMT)
Placebo Comparator: Placebo in part 2
The traditional treatments and normal saline will be used in patients with ulcerative colitis in part 2 according to associated guidelines.
Other: Normal Saline
Normal saline and the traditional treatments for ulcerative colitisin in part 2.
Other Name: Normal Saline(NS)
- Incidence of treatment-emergent adverse events [ Time Frame: 3 months ]According to the inclusion criteria, the patients were randomly divided into experimental group and control group. Before and after the fecal microbiota transplantation, patients were asked about the history of abdominal pain, abdominal distension, diarrhea and so on,at the same time, monitoring heart rate, respiration, pulse, blood pressure is necessary and determinating liver function, renal function, electrolytes, blood coagulation, blood lipids, endotoxins and other biochemical tests to evaluate clinical efficacy.
- Improvement of clinical symptoms of the treatment [ Time Frame: 4 week ]We evaluate the improvement of clinical symptoms of the treatment through Clinical Symptom Score of ulcerative colitis and Endoscopic Rachmilewitz Scoreto.
- The influence of interleukin-10 after the treatment [ Time Frame: 0-4 week ]Inflammatory factors such as interleukin-10 in the blood of patients with ulcerative colitis and indicators of disease activity such as erythrocyte sedimentation rate, C-reactive protein are often elevated, we want to study the change above indicators before and after treatment, reflecting the improvement of Inflammation of ulcerative colitis and study the effect of its activity.
- Intestinal mucosal immunity [ Time Frame: 4 week ]Ulcerative colitis is an autoimmune disease, it is closely related to the secretory SIgA, and content of serum secretory SIgA of ulcerative colitis patients often decreased. By measuring serum secreted SIgA before and after the treatment of to reflect the immune function of ulcerative colitis.
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): NCT03016780
|Contact: Xiaoan Li, Ph.Demail@example.com|
|IEC of Chengdu Medical College||Recruiting|
|Chendu, China, 610500|
|Contact: Xiaoan Li, Ph.D +8613680868858 firstname.lastname@example.org|
|Study Chair:||Xiaoan Li, Ph.D||First Affiliated Hospital of Chengdu Medical College|