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Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression

Primary Purpose

Ulcerative Colitis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intestinal flora capsule
placebo capsule
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis，Depression，FMT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. The course of the disease is more than 6 months, and it is clearly diagnosed as ulcerative colitis with depression.【Diagnostic criteria: (2020) "JSGE Evidence-based Clinical Practice Guidelines: Inflammatory Bowel Disease" and "Chinese Mental Disorders Classification and Diagnostic Standards" (CCMD) -3) The relevant standards in the above, and also meet the improved Mayo score ≤ 10 points, PHQ9 score ≥ 5 points】;
  2. There is no restriction on men and women, aged between 18-65 years old;
  3. BMI is between 18-30kg/m2;
  4. Have basic reading comprehension skills;
  5. No other serious diseases such as heart, brain, lung, liver, and kidney are complicated;
  6. Have not traveled abroad in the past month, and have no history of alcoholism, drug abuse, or smelting;
  7. No antibiotics and probiotic preparations have been used within one month;
  8. Agree to participate in this study and sign an informed consent form.

Exclusion Criteria:

  1. Age <18 years old or >65 years old;
  2. Patients with unspecified ulcerative colitis;
  3. Authors with bipolar disorder, persistent mood disorder, and mania;
  4. Malignant tumors such as gastrointestinal infection, irritable bowel syndrome, bowel cancer and other gastrointestinal diseases;
  5. A history of gastrointestinal surgery;
  6. Patients during pregnancy and lactation;
  7. Complicated with obesity, hypertension, diabetes, heart disease, stroke and other serious chronic diseases (hereditary, metabolic, endocrine diseases);
  8. Infectious diseases: hepatitis B or C, HIV, syphilis (rapid recovery of positive plasma), Epstein-Barr virus and cytomegalovirus infection (IgM positive);
  9. Abnormal liver function: AST or ALT higher than 2 times the upper limit of normal; renal insufficiency: serum Cr higher than 1.5 times the upper limit of normal or eGFR<60ml/min; dyslipidemia (TC> 4.0 mmol/L, TG >2.0 mmol/L, LDL-c>2.5 mmol/L, HDL-c<1.0 mmol/L), CRP>8mg/L;
  10. Anticoagulation therapy;
  11. Patients who were participating in other clinical trials at the time of enrollment;
  12. Those who do not agree to join the group or have various factors affecting compliance and other people who are not suitable for participating in clinical trials.

Sites / Locations

  • Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intestinal flora capsule(FMT)

Placebo group

Arm Description

The group includes 27patients.They will receive 16 capsules of intestinal bacteria each time, once a week, 4 times in a row.Each capsule contains 200mg of fecal bacteria.

The group includes 27patients.They will receive 16 Placebo capsules each time, once a week, 4 times in a row.

Outcomes

Primary Outcome Measures

PHQ-9 score
Patien Health Questionnare.The total score is 0-27 points, 0-4 points: no depression; 5-9 points: mild depression; 10-14 points: moderate depression; 15-27 points: severe depression. The higher the score, the worse the depression.

Secondary Outcome Measures

SDS-score
Self-Rating Depression Scale.Standard total score: normal <53 points; 53-62 for mild depression; 63-72 for moderate depression; >72 for severe depression.The higher the score, the worse the depression.
HAMA-score
Hamilton Anxiety Scale.The total score is 0-56, among which, physical anxiety: 7-13 items; mental anxiety: 1-6 and 14 items.The higher the score, the greater the anxiety.
HAMD-score
Hamilton Depression Scale.The total score is 0-35 points: >35 points: severe depression; >20 points: mild or moderate depression; 8-20 may have depression; <8 points: no depression. The higher the score, the greater the depression.
HADS-score
Hospital Anxiety and Depression Scale.It consists of 14 (7 anxiety and 7 depression-related) scoring items, all ranging from 0-21. The higher the score, the more severe the anxiety and depression.
GSRS-score
Gastrointestinal Symptom Rating Scale . The score varies from 1 6 to 1 1 2 . Higher scores suggest more severe gastrointestinal pathology .
Modified Mayo score
Modified Mayo score for ulcerative colitis: a total of 0-12 points, scores ≤ 2 points and no single sub-item score> 1 points to clinical remission, 3 to 5 points to mild activity, 6 to 10 points to moderate activity, 11 ~12 is divided into heavy activity.The higher the score, the more severe the condition.
IBD-QoL
Quality of Life Analysis Table for Patients with Inflammatory Bowel Disease: There are 32 questions in total. Each question has a different level of answer from 1 to 7, 1 generation The table has the heaviest degree, and 7 represents the least degree.Total score 0-224,The higher the score, the higher the quality of life.

Full Information

First Posted
August 9, 2021
Last Updated
August 30, 2021
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05030064
Brief Title
Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
Official Title
Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 10, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a single-center trial, randomized, single-blind, placebo-controlled clinical intervention study which intends to explore the safety and effectiveness of FMT capsule for the treatment of ulcerative colitis with depression.
Detailed Description
A total of 54 patients with definite diagnosis of ulcerative colitis (light-to-moderate active period) with depressive state were included. According to the random table, patients were randomly divided into the FMT capsule group and the placebo group, and received the FMT capsule and placebo interventions once a week for 4 consecutive times, respectively. The patients were followed up at the 4th, 8th and 12th week of intervention, and a simple physical examination was performed to evaluate the patient's condition changes (abdominal pain degree score, diarrhea frequency, stool characteristics and extraintestinal manifestations such as skin and joints) and modified Mayo score , IBD-QOL scale, PHQ9, SDS, HADS, HAMA, HAMD scale, etc. The improvement and effective colonization of the intestinal flora in the FMT capsule group or the placebo group of patients with depression and IBD were observed by methods such as 16S rRNA analysis of the intestinal flora In the 12th weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis，Depression，FMT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is planned to recruit UC patients with depression and voluntarily receive standard enterobacteria capsule or placebo treatment. A total of 54 cases will be completely randomized according to the random number table and randomly divided into 2 groups for intervention.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intestinal flora capsule(FMT)
Arm Type
Experimental
Arm Description
The group includes 27patients.They will receive 16 capsules of intestinal bacteria each time, once a week, 4 times in a row.Each capsule contains 200mg of fecal bacteria.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
The group includes 27patients.They will receive 16 Placebo capsules each time, once a week, 4 times in a row.
Intervention Type
Drug
Intervention Name(s)
Intestinal flora capsule
Other Intervention Name(s)
Fecal Bacteria Transplant
Intervention Description
This research group has independently researched and created a human intestinal flora capsule based on "intestinal bacteria transplantation": Intestinal flora capsule, which has been declared a national invention patent (patent number: 2015103040414).
Intervention Type
Procedure
Intervention Name(s)
placebo capsule
Other Intervention Name(s)
Placebo control
Intervention Description
Each placebo capsule is the two-layer empty capsule shell of the Intestinal flora capsule, which is made of titanium dioxide and iron oxide yellow. It is non-toxic and has the same appearance as the authentic Intestinal flora capsule.
Primary Outcome Measure Information:
Title
PHQ-9 score
Description
Patien Health Questionnare.The total score is 0-27 points, 0-4 points: no depression; 5-9 points: mild depression; 10-14 points: moderate depression; 15-27 points: severe depression. The higher the score, the worse the depression.
Time Frame
12 Weeks after treatment.
Secondary Outcome Measure Information:
Title
SDS-score
Description
Self-Rating Depression Scale.Standard total score: normal <53 points; 53-62 for mild depression; 63-72 for moderate depression; >72 for severe depression.The higher the score, the worse the depression.
Time Frame
12 Weeks after treatment.
Title
HAMA-score
Description
Hamilton Anxiety Scale.The total score is 0-56, among which, physical anxiety: 7-13 items; mental anxiety: 1-6 and 14 items.The higher the score, the greater the anxiety.
Time Frame
12 Weeks after treatment.
Title
HAMD-score
Description
Hamilton Depression Scale.The total score is 0-35 points: >35 points: severe depression; >20 points: mild or moderate depression; 8-20 may have depression; <8 points: no depression. The higher the score, the greater the depression.
Time Frame
12 Weeks after treatment.
Title
HADS-score
Description
Hospital Anxiety and Depression Scale.It consists of 14 (7 anxiety and 7 depression-related) scoring items, all ranging from 0-21. The higher the score, the more severe the anxiety and depression.
Time Frame
12 Weeks after treatment.
Title
GSRS-score
Description
Gastrointestinal Symptom Rating Scale . The score varies from 1 6 to 1 1 2 . Higher scores suggest more severe gastrointestinal pathology .
Time Frame
12 Weeks after treatment.
Title
Modified Mayo score
Description
Modified Mayo score for ulcerative colitis: a total of 0-12 points, scores ≤ 2 points and no single sub-item score> 1 points to clinical remission, 3 to 5 points to mild activity, 6 to 10 points to moderate activity, 11 ~12 is divided into heavy activity.The higher the score, the more severe the condition.
Time Frame
12 Weeks after treatment.
Title
IBD-QoL
Description
Quality of Life Analysis Table for Patients with Inflammatory Bowel Disease: There are 32 questions in total. Each question has a different level of answer from 1 to 7, 1 generation The table has the heaviest degree, and 7 represents the least degree.Total score 0-224,The higher the score, the higher the quality of life.
Time Frame
12 Weeks after treatment.
Other Pre-specified Outcome Measures:
Title
WBC
Description
leukocyte
Time Frame
12 Weeks after treatment.
Title
CRP
Description
C-reactive protein
Time Frame
12 Weeks after treatment.
Title
ESR
Description
erythrocyte sedimentation rate
Time Frame
12 Weeks after treatment.
Title
PCT
Description
procalcitonin
Time Frame
12 Weeks after treatment.
Title
IL-6
Description
interleukin-6
Time Frame
12 Weeks after treatment.
Title
Intestinal flora
Description
16S rRNA sequencing analysis and metagenomics analysis.
Time Frame
12 Weeks after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The course of the disease is more than 6 months, and it is clearly diagnosed as ulcerative colitis with depression.【Diagnostic criteria: (2020) "JSGE Evidence-based Clinical Practice Guidelines: Inflammatory Bowel Disease" and "Chinese Mental Disorders Classification and Diagnostic Standards" (CCMD) -3) The relevant standards in the above, and also meet the improved Mayo score ≤ 10 points, PHQ9 score ≥ 5 points】; There is no restriction on men and women, aged between 18-65 years old; BMI is between 18-30kg/m2; Have basic reading comprehension skills; No other serious diseases such as heart, brain, lung, liver, and kidney are complicated; Have not traveled abroad in the past month, and have no history of alcoholism, drug abuse, or smelting; No antibiotics and probiotic preparations have been used within one month; Agree to participate in this study and sign an informed consent form. Exclusion Criteria: Age <18 years old or >65 years old; Patients with unspecified ulcerative colitis; Authors with bipolar disorder, persistent mood disorder, and mania; Malignant tumors such as gastrointestinal infection, irritable bowel syndrome, bowel cancer and other gastrointestinal diseases; A history of gastrointestinal surgery; Patients during pregnancy and lactation; Complicated with obesity, hypertension, diabetes, heart disease, stroke and other serious chronic diseases (hereditary, metabolic, endocrine diseases); Infectious diseases: hepatitis B or C, HIV, syphilis (rapid recovery of positive plasma), Epstein-Barr virus and cytomegalovirus infection (IgM positive); Abnormal liver function: AST or ALT higher than 2 times the upper limit of normal; renal insufficiency: serum Cr higher than 1.5 times the upper limit of normal or eGFR<60ml/min; dyslipidemia (TC> 4.0 mmol/L, TG >2.0 mmol/L, LDL-c>2.5 mmol/L, HDL-c<1.0 mmol/L), CRP>8mg/L; Anticoagulation therapy; Patients who were participating in other clinical trials at the time of enrollment; Those who do not agree to join the group or have various factors affecting compliance and other people who are not suitable for participating in clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanling Wei, doctorate
Phone
15310354666
Email
lingzi016@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dongfeng Chen, doctorate
Phone
13883032812
Email
chendf1981@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Y Ling
Organizational Affiliation
Army Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dongfeng Chen, doctor
Phone
86-13883032812
Email
chendf1981@126.com
First Name & Middle Initial & Last Name & Degree
Yanling Wei, doctor
Phone
86-15310354666
Email
lingzi016@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression

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