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Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease，but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).
The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for ulcerative colitis(UC). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the intestine. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least three months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal microbiota transplantation | Experimental | Fecal microbiota transplantation |
|
| placebo fecal microbiota transplantation | Sham Comparator | Infusion of Saline |
|
| Traditional treatments | Other | Drug:5-Aminosalicylic acid(5-ASA) and/or Prednisone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation | Procedure | 200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission in patient as assessed using Mayo score | Total Mayo score less than 2 and no signal item more than 1 | 12 weeks |
| Clinical improvement in patient as assessed using Mayo score | Total Mayo score decreased more than 3 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Intestinal microbiota changing | The change of intestinal microbiota composition after FMT compared with subject original microbiota and donor's microbiota | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongli Huang, MM | Contact | 86-13631316718 | honglisums@126.com | |
| Huiting Chen, MM | Contact | 86-13926055294 | gracy1977@tom.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuqiang Nie, MD | Guangzhou First People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou First People's Hospital | Recruiting | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26363929 | Background | Cui B, Li P, Xu L, Zhao Y, Wang H, Peng Z, Xu H, Xiang J, He Z, Zhang T, Nie Y, Wu K, Fan D, Ji G, Zhang F. Step-up fecal microbiota transplantation strategy: a pilot study for steroid-dependent ulcerative colitis. J Transl Med. 2015 Sep 12;13:298. doi: 10.1186/s12967-015-0646-2. |
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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 |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D011241 | Prednisone |
| D019804 | Mesalamine |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
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| Infusion of Saline | Procedure | Infusion of Saline |
|
| 5-Aminosalicylic acid(5-ASA) and/or Prednisone | Drug | Mesalazine and/or Prednisone |
|
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D062368 | meta-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000636 | Aminosalicylic Acids |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |