Fecal Microbiota Transplantation for Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ulcerative Colitis Intestinal Bacteria Flora Disturbance Fecal Microbiota Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment in part 1

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

Group Type ACTIVE_COMPARATOR

Fecal Microbiota Transplantation

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

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

Interventions

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Fecal Microbiota Transplantation

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

Intervention Type OTHER

Normal Saline

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

Intervention Type OTHER

Other Intervention Names

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Fecal Microbiota Transplantation(FMT) Normal Saline(NS)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes