Inflammatory Bowel Disease(IBD) Clinical Trial
— IBDOfficial title:
Efficacy, Safety and Microbiota of Intestinal Microbiota Transplantation for Inflammatory Bowel Diseases
| Verified date | November 2023 |
| Source | Zhongshan Hospital Xiamen University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
There are many limitations in the current treatments of Inflammatory Bowel Diseases(IBD) which includes Ulcerative Colitis（UC) and Crohn's Disease(CD). Some patients have no or little reaction to the traditional drugs. Now the investigators realized that the intestinal microbiota is closely associated with the development of Inflammatory Bowel Diseases. In recent years, a retrospective study showed that the overall efficiency of intestinal microbiota transplantation for IBD was 79%, the overall remission rate was 43%, which opened a new chapter in the treatment of IBD. So the standardized intestinal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators plan to recruit patients with IBD in China. The patients will be randomly divided into two groups, one group will be given treatment of standardized intestinal microbiota transplantation, the other will be simply treated with traditional drugs, followed up for at least 1 year. The investigators aim to determine the efficiency, durability and safety of Intestinal Microbiota Transplantation for IBD treatment, and further to explore which major bacteria may effect in this project.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | December 30, 2022 |
| Est. primary completion date | October 29, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Standard or conventional medicine treatment ineffective of Inflammatory Bowel Diseases(IBD) patients - IBD patients with recurrent symptoms - IBD patients who had drug dependence or recurrence when reduced or discontinued use - Untreated IBD patients who voluntarily received Standardized Intestinal Microbiota Transplantation(IMT) - Written informed consent/assent as appropriate Exclusion Criteria: - IBD patients with contraindications for gastrointestinal endoscopy - IBD patients with indication of surgery - Moderate and severe renal injuty(serum creatinine>2mg/dL or 177mmol/L), moderate and severe chronic obstructive pulmonary disease, severe hypertension, cerebrovascular accident, congestive heart failure, unstable angina pectoris - Other serious diseases that may interfere the recruitment or affect the survival, such as cancer or acquired immune deficiency syndrome - Mentally or legally disabled person - Preparing for pregnancy - Medical or social condition which in the opinion of the principal investigator would interfere with or prevent regular follow up - Participating in other clinical trials. |
| Country | Name | City | State |
|---|---|---|---|
| China | Zhongshan Hospital Affiliated to Xiamen University | Xiamen | Fujian |
| Lead Sponsor | Collaborator |
|---|---|
| Zhongshan Hospital Xiamen University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The change of the modified Mayo score | Clinical remission defined as modified Mayo score?2. Change from baseline will be assessed at different timepoint.The endpoint of follow-up is the time of clinical recurrence. | 1 month, 3 months, 6months, 12 months | |
| Secondary | The change of CDAI | Clinical remission defined as CDAI(Crohn's disease activity index )?150.Change from baseline will be assessed at different timepoint. The endpoint of follow-up is the time of clinical recurrence. | 1 month, 3 months, 6months,12 months | |
| Secondary | Relief of gastrointestinal symptoms | The onset and duration of gastrointestinal symptoms will be assessed by "Evaluation Score Table of Gastrointestinal Symptoms".Change from baseline will be assessed at different timepoint. | 1 months, 3 months, 6 months, 12months | |
| Secondary | Changes of gut microbiota | Alpha and Beta diversity of GI microbiota by High-throughput sequencing on baseline line and1 month, 3 months, 6months ,12 months after treatment. | 1 months, 3 months, 6 months, 12months |