Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Study Overview
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Brief Summary
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Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. FMT has a higher cure rate than standard antibiotic treatment for recurrent Clostridium difficile infections,and shows promising results in Inflammatory bowel disease（IBD）.However, few studies have evaluated whether FMT is effective to treat Irritable bowel syndrome(IBS).The investigators propose to determine the efficiency and safety of FMT in patients with Irritable bowel syndrome.

Detailed Description
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The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for Irritable bowel syndrome(IBS). We established a standard microbiota isolation from donated fresh stool in lab. Then the microbiota is transplanted to the whole colon through a tube. Patients from Guangzhou First People's Hospital in this study will be assigned to receive FMT at least two times according to associated guidelines and follow-up for at least six months. Questionnaires will be used to assess participants at study start and at study completion.

Official Title
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Efficacy and Safety of Fecal Microbiota Transplantation for Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome, Fecal Microbiota Transplantation

Intervention / Treatment
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* Procedure: fecal microbiota transplantation
* Procedure: Infusion of sham
* Drug: probiotics, antibiotics or antidepressants


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: To be considered eligible for enrolment into the study, subjects must: Be able to give written informed consent. Males and females aged >18 and <75 Have IBS as defined by the Rome IV criteria Exclusion Criteria: Subjects will be excluded from the study if they meet any of the below criteria: pregnant or having a follow-up of less than 6 months; unable to give informed consent; suffering from other severe disease ,including liver and kidney failure, cancers, intestinal diseases, inflammatory bowel disease, C difficile infection; unable to undergo endoscopy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fecal microbiota transplantation<br>fecal microbiota transplantation | Procedure: fecal microbiota transplantation<br>* 200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon<br>|
| Sham Comparator: placebo fecal microbiota transplantation<br>Infusion of sham | Procedure: Infusion of sham<br>* Infusion of sham<br>|
| Sham Comparator: Traditional treatments<br>Traditional treatments according to associated guidelines such as probiotics, antibiotics or antidepressants | Drug: probiotics, antibiotics or antidepressants<br>* Drugs such as probiotics, antibiotics, antidepressants<br>* Other names: Clostridium butyricum TO-A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Irritable Bowel Syndrome assessed by Symptom Severity Score (IBS-SSS) | This questionnaire was used for assessing IBS severity. Scores of five questions were calculated with the Visual Analogue Scale (VAS) scale: the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits and interference with quality of life. The scores ranged from 0 to 500, a higher score indicating worse condition :<75 indicated remission; 75-175 indicated mild IBS;176-300 indicated moderate IBS; and > 300 indicated severe IBS . | baseline; one month;three months;six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Irritable Bowel Syndrome assessed by Quality of Life (IBS-QOL) Questionnaire Scores | The IBS-QOL questionnaire consisted of 34 items, covering eight aspects (dysphoria, interference with activity, body image, health worry, food avoidance,social reaction, sexual dysfunction, and relationships). Each item was rated on a 5-point Likert scale(1 = not at all, 5 = a great deal). Total scores were transformed to a 0±100 scale ranging from 0 (maximum quality of life) to 100 (poor quality of life). | baseline; one month;three months;six months | 
| Change in Depression and Anxiety assessed by Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale(HAMA) | The Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA) were used to evaluate the mental and psychological states of patients. HAMD scores were graded as follows: 8-19, mild depression; 20-34, moderate depression; ≥35, severely depression. HAMA scores were graded as follows: 14-20, mild anxiety; 21-28, moderate anxiety;≥29 , severe anxiety. | baseline; one month;three months;six months |