Chronic Intestinal Pseudo Obstruction Clinical Trial
Official title:
Efficacy and Safety of Fecal Microbiota Transplantation in Treatment of Chronic Intestinal Pseudo-obstruction: a Preliminary Study
| Verified date | August 2017 |
| Source | Jinling Hospital, China |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Chronic intestinal pseudo obstruction(CIPO) is a serious motility disorder with life-threatening condition, and it is often related with bacterial overgrowth. Fecal microbiota transplantation (FMT) results in restoration of the normal intestinal microbial community structure. The investigators planned to observe the efficacy of FMT in the treatment of a series CIPO patients. Patients received FMT on 6 consecutive days through nasojejunal tubes and followed up for 8 weeks after treatment. Rate of clinical improvement and remission, feeding tolerance of enteral nutrition, CT score of intestinal obstruction, and gastrointestinal quality-of-life index(GIQLI) were evaluated.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | March 2016 |
| Est. primary completion date | September 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: Patients had to have a ?rm diagnosis diagnostic criteria for CIPO proposed by Ministry of Health, Labour, and Welfare, including documented pathological bowel dilatation on imaging in the absence of mechanical obstruction. Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| China | Department of Generay Surgery, Jinling hosptal, Medical School of Nanjing University | Nanjing | Jiangsu |
| Lead Sponsor | Collaborator |
|---|---|
| Jinling Hospital, China |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the tolerance of enteral nutrition (EN) through nasojejunal tube | We defined feeding intolerance (FI) as inability to deliver the amount of nutrient as a proportion of 'energy requirements', with values of 80% chosen, or a certain amount (750ml) per 24h. | 8 weeks | |
| Primary | the time oral intake started | The time when oral intake (both fluids and solid food) started was noted. | 8 weeks | |
| Secondary | symptomatic relief | The occurrence and severity of each of these symptoms: pain, nausea, vomiting and bloating (each scored as 0 = absent, 1 = mild, 2 = medium, 3 = severe, or 4 = could not be worse) were recorded by nurses blinded to the intervention on a daily basis. | 8 weeks | |
| Secondary | scoring evaluation of abdominal CT | We use a computed tomography scoring system to evaluate the severity of obstruction. | 8 weeks |