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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
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Chengdu Medical College

Brief Summary:
Ulcerative colitis is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of ulcerative colitis is closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be related to intestinal flora. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease,but the efficacy of ulcerative colitis by fecal microbiota transplantation needs to be further explored.

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

Detailed Description:
Patients who meet the inclusion crit ulcerative colitisby will be separated into two parts depending on accepation or refuse of Fecal microbiota transplantation.Blood specimen from patients will be collected to analysis intestinal mucosal immunity.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. subjects voluntarily participate in the trial and sign informed consent;
  2. sex is not limited,ranging from 18 to 75 years old;
  3. meet the diagnostic criteria for ulcerative colitis in patients;
  4. be able to communicate well with the researchers and follow the verification requirements.

Exclusion criteria:

  1. Pregnancy or people who are not to give informed consent;
  2. use of major immunosuppressive agents, including the use of large doses of glucocorticoids, calcineurin inhibitors, mTOR inhibitors, depleted lymphocyte biological agents, anti-tumor necrosis factor and other conditions; chemotherapy of antineoplastic drugs;
  3. decompensated cirrhosis, progressive AIDS and HIV infectionor other serious immunodeficiency disease;
  4. use of antibiotics and probiotics within six weeks;
  5. with severe complications such as local stenosis, intestinal obstruction, intestinal perforation, toxic colon expansion, colon cancer, rectal cancer patients;
  6. combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary disease, mental illness.

Information from the National Library of Medicine

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


Contacts
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Contact: Xiaoan Li, Ph.D +8613880868858 zqzy1983@163.com

Locations
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China
IEC of Chengdu Medical College Recruiting
Chendu, China, 610500
Contact: Xiaoan Li, Ph.D    +8613680868858    zqzy1983@163.com   
Sponsors and Collaborators
First Affiliated Hospital of Chengdu Medical College
Investigators
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Study Chair: Xiaoan Li, Ph.D First Affiliated Hospital of Chengdu Medical College

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: First Affiliated Hospital of Chengdu Medical College
ClinicalTrials.gov Identifier: NCT03016780     History of Changes
Other Study ID Numbers: FMT-IBD
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by First Affiliated Hospital of Chengdu Medical College:
Ulcerative Colitis
Intestinal Bacteria Flora Disturbance
Fecal Microbiota Transplantation
Intestinal Mucosal Immunity
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Dysbiosis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases