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

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ClinicalTrials.gov Identifier: NCT05030064
Recruitment Status : Recruiting
First Posted : September 1, 2021
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Yanling Wei, Third Military Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Intestinal flora capsule Procedure: placebo capsule Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Clinical Study on the Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
Estimated Study Start Date : September 10, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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).
Other Name: Fecal Bacteria Transplant
Placebo Comparator: Placebo group
The group includes 27patients.They will receive 16 Placebo capsules each time, once a week, 4 times in a row.
 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.
Other Name: Placebo control


Outcome Measures
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Primary Outcome Measures :
  1. PHQ-9 score [ Time Frame: 12 Weeks after treatment. ]
    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 :
  1. SDS-score [ Time Frame: 12 Weeks after treatment. ]
    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.

  2. HAMA-score [ Time Frame: 12 Weeks after treatment. ]
    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.

  3. HAMD-score [ Time Frame: 12 Weeks after treatment. ]
    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.

  4. HADS-score [ Time Frame: 12 Weeks after treatment. ]
    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.

  5. GSRS-score [ Time Frame: 12 Weeks after treatment. ]
    Gastrointestinal Symptom Rating Scale . The score varies from 1 6 to 1 1 2 . Higher scores suggest more severe gastrointestinal pathology .

  6. Modified Mayo score [ Time Frame: 12 Weeks after treatment. ]
    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.

  7. IBD-QoL [ Time Frame: 12 Weeks after treatment. ]
    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.


Other Outcome Measures:
  1. WBC [ Time Frame: 12 Weeks after treatment. ]
    leukocyte

  2. CRP [ Time Frame: 12 Weeks after treatment. ]
    C-reactive protein

  3. ESR [ Time Frame: 12 Weeks after treatment. ]
    erythrocyte sedimentation rate

  4. PCT [ Time Frame: 12 Weeks after treatment. ]
    procalcitonin

  5. IL-6 [ Time Frame: 12 Weeks after treatment. ]
    interleukin-6

  6. Intestinal flora [ Time Frame: 12 Weeks after treatment. ]
    16S rRNA sequencing analysis and metagenomics analysis.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05030064


Contacts
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Contact: Yanling Wei, doctorate 15310354666 lingzi016@126.com
Contact: Dongfeng Chen, doctorate 13883032812 chendf1981@126.com

Locations
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China, Chongqing
Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Dongfeng Chen, doctor    86-13883032812    chendf1981@126.com   
Contact: Yanling Wei, doctor    86-15310354666    lingzi016@126.com   
Sponsors and Collaborators
Third Military Medical University
Investigators
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Principal Investigator: Wei Y Ling Army Medical Center
More Information
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Responsible Party: Yanling Wei, Deputy Chief Physician, Third Military Medical University
ClinicalTrials.gov Identifier: NCT05030064    
Other Study ID Numbers: TMMU-DP-GI-FMT-003
First Posted: September 1, 2021    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanling Wei, Third Military Medical University:
Ulcerative Colitis，Depression，FMT
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Depression
Behavioral Symptoms
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases