Fecal Microbiota Transplantation for Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— FMTFUC  

Official title:

Evaluation of The Effect of Fecal Microbiota Transplantation on Ulcerative Colitis and Its Mechanism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03016780
• Other study ID #: FMT-IBD
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: January 3, 2017
• Last updated: January 7, 2017
• Start date: July 2016
• Est. completion date: July 2019

Study information

• Verified date: December 2016
• Source: First Affiliated Hospital of Chengdu Medical College
• Contact: Xiaoan Li, Ph.D
• Phone: +8613880868858
• Email: zqzy1983[@]163.com
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Sichuan Province
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2019
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Dysbiosis
• Fecal Microbiota Transplantation
• Intestinal Bacteria Flora Disturbance
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Fecal Microbiota Transplantation
Fecal microbiota transplantation and the traditional treatments for ulcerative colitis in part 1.
• Normal Saline
Normal saline and the traditional treatments for ulcerative colitisin in part 2.

Locations

Country	Name	City	State
China	IEC of Chengdu Medical College	Chendu

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Chengdu Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events	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.	3 months	Yes
Secondary	Improvement of clinical symptoms of the treatment	We evaluate the improvement of clinical symptoms of the treatment through Clinical Symptom Score of ulcerative colitis and Endoscopic Rachmilewitz Scoreto.	4 week	No
Secondary	The influence of interleukin-10 after the treatment	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.	0-4 week	No
Secondary	Intestinal mucosal immunity	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.	4 week	No