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| Name | Class |
|---|---|
| Chinese University of Hong Kong | OTHER |
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Fecal microbiota transplantation (FMT), defined as infusion of feces from healthy donors to affected subjects, is a method to restore a balanced gut microbiota and has attracted great interest in recent years due to its efficacy and ease of use.
FMT is now recommended as the most effective therapy for CDI not responding to standard therapies1.Recent studies have suggested that dysbiosis is associated with a variety of disorders, and that FMT could be a useful treatment. Randomized controlled trial has been conducted in a number of disorders including ulcerative colitis (UC). Our study is aims to Fecal microbiota transplantation in the treatment of Inflammatory Bowel Disease, the role of selection of the Dai ethnic group as donor source in terms of treatment efficacy and pathogenic mechanisms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Han ethnic-UC | Experimental | Ulcerative colitis subjects will be treated with bacterial solution from Han ethnic by endoscopy |
|
| Han ethnic-CD | Experimental | Crohn's disease subjects will be treated with bacterial solution from Han ethnic by endoscopy |
|
| Dai ethnic-UC | Experimental | Ulcerative colitis subjects will be treated with bacterial solution from Dai ethnic by endoscopy |
|
| Dai ethnic-CD | Experimental | Crohn's disease subjects will be treated with bacterial solution from Dai ethnic by endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopy | Device | transplant infusion of feces from healthy donors into affected subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| steroid-free clinical remission and endoscopic remission | The primary outcome is a composite of steroid-free clinical remission together with endoscopic remission or response at week 6, defined as defined as a total Mayo score of ≤2 points with no individual sub-score >1 point, and at least a 1 point reduction from baseline in the endoscopy sub-score | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Steroid-free clinical remission | defined as combined Mayo sub-scores of 1 or less for rectal bleeding plus stool frequency | 3 years |
| Steroid-free clinical response | defined as either a decrease of 3 points or more on the Mayo score, a 50% or greater reduction from baseline in combined rectal bleeding plus stool frequency Mayo sub-scores, or both |
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Inclusion Criteria:
Exclusion Criteria:
Allowed concomitant medications:
The following drugs are allowed as long as the dose is stable preceding first FMT for the noted time:
Prohibited medications:
The following drugs for are prohibited for the noted time:
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| Name | Affiliation | Role |
|---|---|---|
| Y L Miao, doctor | First Affiliated Hospital of Kunming Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Endoscopy | Kunming | Yunnan | 650032 | China |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2026 | |
| Reset | May 28, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2026 | May 28, 2026 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| 3 years |
| Steroid-free endoscopic response | defined as a Mayo endoscopy sub-score of 1 or less, with a reduction of at least 1 point from baseline | 3 years |
| microbiological change | Changes in microbial composition (including bacteriome, virome and fungome), function and metabolite | 3 years |
| Change in microbiome of stool | Change in microbiome of stool (including bacteriome, virome and fungome) | 3 years |
| Difference in microbiome compared between subjects in different treatment arm | Difference in microbiome (including bacteriome, virome and fungome) compared between subjects in different treatment arm | 3 years |
| Proportion of microbiome | Proportion of microbiome (including bacteriome, virome and fungome) derived from recipient, donor or both in subjects who received FMT | 3 years |
| Difference in microbiome compared between subjects who have weight loss and those do not have weight loss | Difference in microbiome (including bacteriome, virome and fungome) compared between subjects who have weight loss and those do not have weight loss | 3 years |
| Microbial factors that are associated with percentage of body weight loss | Microbial factors (including bacteriome, virome and fungome) that are associated with percentage of body weight loss | 3 years |
| Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome | Trans-kingdom correlation of microbial engraftment after FMT between bacteriome, virome and fungome | 3 years |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D013514 | Surgical Procedures, Operative |