Fecal Microbiota Transplantation for Ulcerative Colitis

Phase 1

• Conditions: Fecal Microbiota Transplantation; Ulcerative Colitis; Intestinal Bacteria Flora Disturbance
• Interventions: Other: Fecal Microbiota Transplantation; Other: Normal Saline

• Registration Number: NCT03016780
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-07
• Status Verified: 2016-12
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-07
• Last Update Submitted: 2017-01-07
• Study First Posted: 2017-01-11
• Last Update Posted: 2017-01-11
• Primary Completion: 2018-07
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment in part 1	Fecal Microbiota Transplantation	Fecal microbiota transplantation and traditional treatments will be used in patients with ulcerative colitis in part 1.
Placebo in part 2	Normal Saline	The traditional treatments and normal saline will be used in patients with ulcerative colitis in part 2 according to associated guidelines.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events	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

Name	Time	Method
Improvement of clinical symptoms of the treatment	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	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	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.

Trial Locations

Locations (1)

IEC of Chengdu Medical College; 🇨🇳 Chendu, China