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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Placebo group | Placebo Comparator | The group includes 27patients.They will receive 16 Placebo capsules each time, once a week, 4 times in a row. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SDS-score | 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. | 12 Weeks after treatment. |
| HAMA-score |
| Measure | Description | Time Frame |
|---|---|---|
| WBC | leukocyte | 12 Weeks after treatment. |
| CRP | C-reactive protein | 12 Weeks after treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanling Wei, doctorate | Contact | 15310354666 | lingzi016@126.com | |
| Dongfeng Chen, doctorate | Contact | 13883032812 | chendf1981@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Y Ling | Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, Research Institute of Surgery, Da ping Hospital, The Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | 400042 | China |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069196 | Gastrointestinal Microbiome |
| ID | Term |
|---|---|
| D064307 | Microbiota |
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
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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.
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| 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. |
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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. |
| 12 Weeks after treatment. |
| HAMD-score | 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. | 12 Weeks after treatment. |
| HADS-score | 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. | 12 Weeks after treatment. |
| GSRS-score | Gastrointestinal Symptom Rating Scale . The score varies from 1 6 to 1 1 2 . Higher scores suggest more severe gastrointestinal pathology . | 12 Weeks after treatment. |
| Modified Mayo score | 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. | 12 Weeks after treatment. |
| IBD-QoL | 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. | 12 Weeks after treatment. |
| ESR | erythrocyte sedimentation rate | 12 Weeks after treatment. |
| PCT | procalcitonin | 12 Weeks after treatment. |
| IL-6 | interleukin-6 | 12 Weeks after treatment. |
| Intestinal flora | 16S rRNA sequencing analysis and metagenomics analysis. | 12 Weeks after treatment. |
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D017753 |
| Ecosystem |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |