Fecal Microbiota Transplantation for Ulcerative Colitis

NCT03016780 | Unknown Phase 1 DMC

• 1 other identifier: FMT-IBD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis; Intestinal Bacteria Flora Disturbance; Fecal Microbiota Transplantation

Keywords

Ulcerative Colitis; Intestinal Bacteria Flora Disturbance; Fecal Microbiota Transplantation; Intestinal Mucosal Immunity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Improvement of clinical symptoms of the treatment

  4 week

• The influence of interleukin-10 after the treatment

  0-4 week

• Intestinal mucosal immunity

  4 week

Study Arms (2)

Treatment in part 1

ACTIVE COMPARATOR

Fecal microbiota transplantation and traditional treatments will be used in patients with ulcerative colitis in part 1.

Other: Fecal Microbiota Transplantation

Placebo in part 2

PLACEBO COMPARATOR

The traditional treatments and normal saline will be used in patients with ulcerative colitis in part 2 according to associated guidelines.

Other: Normal Saline

Interventions

Fecal Microbiota Transplantation OTHER

Fecal microbiota transplantation and the traditional treatments for ulcerative colitis in part 1.

Also known as: Fecal Microbiota Transplantation(FMT)

Treatment in part 1

Normal Saline OTHER

Normal saline and the traditional treatments for ulcerative colitisin in part 2.

Also known as: Normal Saline(NS)

Placebo in part 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or people who are not to give informed consent;
• 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;
• decompensated cirrhosis, progressive AIDS and HIV infectionor other serious immunodeficiency disease;
• use of antibiotics and probiotics within six weeks;
• with severe complications such as local stenosis, intestinal obstruction, intestinal perforation, toxic colon expansion, colon cancer, rectal cancer patients;
• combined with cardiovascular, cerebrovascular, liver, kidney and hematopoietic system and other serious primary disease, mental illness.

Sponsors & Collaborators

• First Affiliated Hospital of Chengdu Medical College: lead

Study Sites (1)

IEC of Chengdu Medical College

Chendu, 610500, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31272391 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation; Saline Solution

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Xiaoan Li, Ph.D

  First Affiliated Hospital of Chengdu Medical College

  STUDY CHAIR

Central Study Contacts

Xiaoan Li, Ph.D

CONTACT

+8613880868858; zqzy1983@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 11, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2019
• Last Updated: January 11, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)