Fecal Microbiota Transplantation for Ulcerative Colitis (FMTFUC)

First Affiliated Hospital of Chengdu Medical College

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Intestinal Bacteria Flora Disturbance; Ulcerative Colitis; Fecal Microbiota Transplantation

Treatments: Other: Normal Saline; Other: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT03016780

FMT-IBD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Treatment in part 1

Active Comparator group

Description:

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

Treatment:

Other: Fecal Microbiota Transplantation

Placebo in part 2

Placebo Comparator group

Description:

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

Treatment:

Other: Normal Saline