Fecal Microbiota Transplantation for Ulcerative Colitis (FMTFUC)

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

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.

Study Overview

• Status: Unknown
• Conditions: Ulcerative Colitis; Intestinal Bacteria Flora Disturbance; Fecal Microbiota Transplantation
• Intervention / Treatment: Other: Fecal Microbiota Transplantation; Other: Normal Saline

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Chendu, China, 610500
    • Recruiting
    • IEC of Chengdu Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Normal Saline(NS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chengdu Medical College

Publications and helpful links

General Publications

• Tian Y, Zhou Y, Huang S, Li J, Zhao K, Li X, Wen X, Li XA. Fecal microbiota transplantation for ulcerative colitis: a prospective clinical study. BMC Gastroenterol. 2019 Jul 4;19(1):116. doi: 10.1186/s12876-019-1010-4.

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 7, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: January 7, 2017
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Fecal Microbiota Transplantation; Ulcerative Colitis; Intestinal Bacteria Flora Disturbance; Intestinal Mucosal Immunity
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Dysbiosis
• Other Study ID Numbers: FMT-IBD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO