Fecal Microbiota Transplantation for Constipation

Study Overview
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Brief Summary
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Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation.

Detailed Description
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Difficult defecation is a common symptom involving with patients'life quality. The stool pattern of these patients might be related to the contribution of gut microbiota. This pilot study proposed hypothesis that stool pattern could be used as a simple index to screen the potential candidates of fecal microbiota transplantation in patients with difficult defecation. Patients underwent single FMT in this study were divided into hard-stool group and loose-stool group. All patients were assessed before FMT and during 12-week follow-up after FMT.

Official Title
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Fecal Microbiota Transplantation for Constipation With Difficult Defecation

Conditions
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Gut Microbiota, Constipation

Intervention / Treatment
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* Drug: Fecal Microbiota suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 14-80 years old; difficult defecation with more than six months (a. straining during defecation; b. sensation of incomplete evacuation; c. sensation of anorectal blockage; d. manual maneuvers to facilitate defecation). Exclusion Criteria: difficult defecation due to secondary factors (e.g. drugs, pelvic surgery, psychiatric disorders); with history of gastrointestinal diseases such as cancer, inflammatory bowel diseases (IBD); pregnant or breast-feeding women; infection with pathogenic bacteria. Enrolled patients were divided into hard-stool group and loose-stool group according to their stool patterns. All patients were followed up for 12 weeks.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 80 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: Fecal microbiota transplantation (FMT)<br>Patients underwent single FMT in this studyAll patients were assessed before FMT and during 12-week follow-up after FMT. | Drug: Fecal Microbiota suspension<br>* The prepared microbiota suspension was infused into mid-gut.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| defecation frequency | frequency of defecation per week | 12 weeks | 
| stool consistency | The category of stool consistency score based on the BSS (Bristol Stool Form Scale) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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difficult defecation, fecal microbiota transplantation, stool pattern