Clinical Study on the Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis With Depression
NCT05030064 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2021-09-01
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
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.
Sponsors & Collaborators
-
Third Military Medical University
lead OTHER
Principal Investigators
-
Wei Y Ling · Army Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-10
- Primary Completion
- 2021-12-31
- Completion
- 2022-08-31
Countries
- China
Study Locations
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