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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05030064
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Third Military Medical University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Wei Y Ling
Principal Investigator Affiliation Army Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Intestinal flora capsule(FMT)

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.

Placebo Comparator: Placebo group

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

Interventions

Drug: - Intestinal flora capsule

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).

Procedure: - placebo capsule

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Chongqing, Chongqing, China

Status

Recruiting

Address

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

Chongqing, Chongqing, 400042

Site Contact

Dongfeng Chen, doctor

chendf1981@126.com

86-13883032812