Fecal Microbiota Transplantation, Intestinal Pseudo-Obstruction
Conditions
Brief summary
Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that primarily affects the movement of the intestines, leading to symptoms that resemble a true bowel obstruction but without a physical blockage. This condition is characterized by impaired motility of the gastrointestinal tract, which can result in severe symptoms and complications. In previous studies, the investigator found that sequential microbiota transplantation therapy can improve clinical symptoms of chronic pseudo-obstruction. Building on this foundation, the current study further investigates the effects of sequential interventions involving intestinal cleansing, small intestine bacterial treatment, fecal microbiota transplantation, and nutritional therapy on the short-term and long-term clinical symptom improvement in patients. Additionally, the investigator aim to elucidate the changes in gut microbiota phenotypes before and after treatment.
Interventions
OTHERsequential fecal microbiota transplant combined with small intestinal fluid transplant
for eligible patients, the investigator use rifaximin, three times daily, 0.4 g each time, lasting 6 days followed by fecal microbiota transplant combined with small intestinal fluid transplant for 6 days. These procedures were repeated every 28 days.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. aged over 18 years old; 2. met the current diagnosis criteria for Chronic Intestinal Pseudo-obstruction; 3. can tolerate nasojejunal tube and complete full course of FMT treatment; 4. the clinical data are relatively complete and there is follow-up available for evaluation
Exclusion criteria
1. accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism; 2. associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enteral Nutrition Tolerance | 8 weeks | the maximal amount of enteral nutrition allowed daily |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nutrition Status | 52 weeks | intersectional muscle and fat area measurements by quantitative computed tomography |
Other
| Measure | Time frame | Description |
|---|---|---|
| Need for surgery | 52 weeks | Surgical interventions are performed due to intestinal nutritional intolerance, including procedures such as nutritional ostomy, decompression ostomy, and intestinal resection. |
| Changes of both colerectal and small intestinal microbiota profile | 8 weeks | Both colorectal and small intestinal bacteria profile before and after treatment. |
Countries
China
Outcome results
None listed