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

NCT05030064 | Unknown DMC

• 1 other identifier: TMMU-DP-GI-FMT-003
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis，Depression，FMT

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Weeks after treatment.

Secondary Outcomes (7)

• SDS-score

  12 Weeks after treatment.

• HAMA-score

  12 Weeks after treatment.

• HAMD-score

  12 Weeks after treatment.

• HADS-score

  12 Weeks after treatment.

• GSRS-score

  12 Weeks after treatment.

Other Outcomes (6)

• WBC

  12 Weeks after treatment.

• CRP

  12 Weeks after treatment.

• ESR

  12 Weeks after treatment.

Study Arms (2)

Intestinal flora capsule(FMT)

EXPERIMENTAL

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.

Drug: Intestinal flora capsule

Placebo group

PLACEBO COMPARATOR

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

Procedure: placebo capsule

Interventions

Intestinal flora capsule DRUG

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).

Also known as: Fecal Bacteria Transplant

Intestinal flora capsule(FMT)

placebo capsule PROCEDURE

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.

Also known as: Placebo control

Placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Gastrointestinal Microbiome

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Microbiota; Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Wei Y Ling

  Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanling Wei, doctorate

CONTACT

15310354666; lingzi016@126.com

Dongfeng Chen, doctorate

CONTACT

13883032812; chendf1981@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: September 1, 2021
• Study Start: September 10, 2021
• Primary Completion: December 31, 2021
• Study Completion: August 31, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)