Efficacy and Safety of Fecal Microbiota Transplantation for Chronic Intestinal Pseudo-obstruction

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Fecal Microbiota Transplantation in Treatment of Chronic Intestinal Pseudo-obstruction: a Preliminary Study

Conditions
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Chronic Intestinal Pseudo Obstruction

Intervention / Treatment
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* Procedure: fecal microbiota transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients had to have a ﬁrm 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: None.

Ages Eligible for Study
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Minimum Age: 18 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: FMT<br>Patients included will receive standard FMT, and then will be followed up for 8 weeks. | Procedure: fecal microbiota transplantation<br>* Patients received frozen FMT on 6 consecutive days through nasojejunal tubes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| the time oral intake started | The time when oral intake (both fluids and solid food) started was noted. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| scoring evaluation of abdominal CT | We use a computed tomography scoring system to evaluate the severity of obstruction. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal Microbiota Transplantation, Chronic intestinal pseudo obstruction, Efficacy and safety