Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Ulcerative colitis is a common digestive system disease, the incidence is increasing in recent years.It is reported that the occurrence and development of ulcerative colitis is closely related to imbalance of intestinal flora .Moreover,intestinal mucosal immunity may be related to intestinal flora. Fecal microbiota transplantation as a new technology to rebuild intestinal flora has been used for several disease,but the efficacy of ulcerative colitis by fecal microbiota transplantation needs to be further explored.
Patients who meet the inclusion crit ulcerative colitisby will be separated into two parts depending on accepation or refuse of Fecal microbiota transplantation.Blood specimen from patients will be collected to analysis intestinal mucosal immunity.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment in part 1 | Active Comparator | Fecal microbiota transplantation and traditional treatments will be used in patients with ulcerative colitis in part 1. |
|
| Placebo in part 2 | Placebo Comparator | The traditional treatments and normal saline will be used in patients with ulcerative colitis in part 2 according to associated guidelines. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Other | Fecal microbiota transplantation and the traditional treatments for ulcerative colitis in part 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | According to the inclusion criteria, the patients were randomly divided into experimental group and control group. Before and after the fecal microbiota transplantation, patients were asked about the history of abdominal pain, abdominal distension, diarrhea and so on,at the same time, monitoring heart rate, respiration, pulse, blood pressure is necessary and determinating liver function, renal function, electrolytes, blood coagulation, blood lipids, endotoxins and other biochemical tests to evaluate clinical efficacy. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of clinical symptoms of the treatment | We evaluate the improvement of clinical symptoms of the treatment through Clinical Symptom Score of ulcerative colitis and Endoscopic Rachmilewitz Scoreto. | 4 week |
| The influence of interleukin-10 after the treatment |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoan Li, Ph.D | Contact | +8613880868858 | zqzy1983@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaoan Li, Ph.D | First Affiliated Hospital of Chengdu Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IEC of Chengdu Medical College | Recruiting | Chendu | 610500 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31272391 | Derived | Tian Y, Zhou Y, Huang S, Li J, Zhao K, Li X, Wen X, Li XA. Fecal microbiota transplantation for ulcerative colitis: a prospective clinical study. BMC Gastroenterol. 2019 Jul 4;19(1):116. doi: 10.1186/s12876-019-1010-4. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Normal Saline | Other | Normal saline and the traditional treatments for ulcerative colitisin in part 2. |
|
|
Inflammatory factors such as interleukin-10 in the blood of patients with ulcerative colitis and indicators of disease activity such as erythrocyte sedimentation rate, C-reactive protein are often elevated, we want to study the change above indicators before and after treatment, reflecting the improvement of Inflammation of ulcerative colitis and study the effect of its activity. |
| 0-4 week |
| Intestinal mucosal immunity | Ulcerative colitis is an autoimmune disease, it is closely related to the secretory SIgA, and content of serum secretory SIgA of ulcerative colitis patients often decreased. By measuring serum secreted SIgA before and after the treatment of to reflect the immune function of ulcerative colitis. | 4 week |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012996 |
| Solutions |
| D004364 | Pharmaceutical Preparations |