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
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis||Drug: Intestinal flora capsule Procedure: placebo capsule||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|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)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 .
- 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.
- 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.
- WBC [ Time Frame: 12 Weeks after treatment. ]leukocyte
- CRP [ Time Frame: 12 Weeks after treatment. ]C-reactive protein
- ESR [ Time Frame: 12 Weeks after treatment. ]erythrocyte sedimentation rate
- PCT [ Time Frame: 12 Weeks after treatment. ]procalcitonin
- IL-6 [ Time Frame: 12 Weeks after treatment. ]interleukin-6
- Intestinal flora [ Time Frame: 12 Weeks after treatment. ]16S rRNA sequencing analysis and metagenomics analysis.
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
|Contact: Yanling Wei, firstname.lastname@example.org|
|Contact: Dongfeng Chen, email@example.com|
|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 firstname.lastname@example.org|
|Contact: Yanling Wei, doctor 86-15310354666 email@example.com|
|Principal Investigator:||Wei Y Ling||Army Medical Center|