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Fecal Microbiota Transplantation for Ulcerative Colitis (FMTFUC)

Primary Purpose

Ulcerative Colitis, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Normal Saline
Sponsored by
First Affiliated Hospital of Chengdu Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation, Intestinal Mucosal Immunity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • IEC of Chengdu Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment in part 1

Placebo in part 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 3, 2017
Last Updated
January 7, 2017
Sponsor
First Affiliated Hospital of Chengdu Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT03016780
Brief Title
Fecal Microbiota Transplantation for Ulcerative Colitis
Acronym
FMTFUC
Official Title
Evaluation of The Effect of Fecal Microbiota Transplantation on Ulcerative Colitis and Its Mechanism
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Chengdu Medical College

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation
Keywords
Ulcerative Colitis, Intestinal Bacteria Flora Disturbance, Fecal Microbiota Transplantation, Intestinal Mucosal Immunity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment in part 1
Arm Type
Active Comparator
Arm Description
Fecal microbiota transplantation and traditional treatments will be used in patients with ulcerative colitis in part 1.
Arm Title
Placebo in part 2
Arm Type
Placebo Comparator
Arm Description
The traditional treatments and normal saline will be used in patients with ulcerative colitis in part 2 according to associated guidelines.
Intervention Type
Other
Intervention Name(s)
Fecal Microbiota Transplantation
Other Intervention Name(s)
Fecal Microbiota Transplantation(FMT)
Intervention Description
Fecal microbiota transplantation and the traditional treatments for ulcerative colitis in part 1.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Other Intervention Name(s)
Normal Saline(NS)
Intervention Description
Normal saline and the traditional treatments for ulcerative colitisin in part 2.
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement of clinical symptoms of the treatment
Description
We evaluate the improvement of clinical symptoms of the treatment through Clinical Symptom Score of ulcerative colitis and Endoscopic Rachmilewitz Scoreto.
Time Frame
4 week
Title
The influence of interleukin-10 after the treatment
Description
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.
Time Frame
0-4 week
Title
Intestinal mucosal immunity
Description
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.
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoan Li, Ph.D
Phone
+8613880868858
Email
zqzy1983@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoan Li, Ph.D
Organizational Affiliation
First Affiliated Hospital of Chengdu Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
IEC of Chengdu Medical College
City
Chendu
ZIP/Postal Code
610500
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoan Li, Ph.D
Phone
+8613680868858
Email
zqzy1983@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31272391
Citation
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.
Results Reference
derived

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Fecal Microbiota Transplantation for Ulcerative Colitis

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