Investigation of Fecal Microbiota Transplant in Chronic Intestinal Pseudo-obstruction Patients

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of Fecal Microbiota Transplant Treatment in Chronic Intestinal Pseudo-obstruction Patients

Conditions
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Intestinal Pseudo-Obstruction, Fecal Microbiota Transplantation

Intervention / Treatment
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* Other: sequential fecal microbiota transplant combined with small intestinal fluid transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged over 18 years old; met the current diagnosis criteria for Chronic Intestinal Pseudo-obstruction; can tolerate nasojejunal tube and complete full course of FMT treatment; the clinical data are relatively complete and there is follow-up available for evaluation Exclusion Criteria: accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sequential antibiotics treatment and fecal + small intestinal microbiota transplant<br> | Other: sequential fecal microbiota transplant combined with small intestinal fluid transplant<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enteral Nutrition Tolerance | the maximal amount of enteral nutrition allowed daily | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition Status | intersectional muscle and fat area measurements by quantitative computed tomography | 52 weeks |