Gut Microbiota Reconstruction in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy as well as safety of rifaximin combined fecal microbiota transplantation(Gut microbiota reconstruction) in the treatment of IBS-D.

Detailed Description
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In this prospective study, there is only one group with no placebo/blank control. All qualified IBS-D patients could be admitted to hospital for at least one time of combing therapy (taking rifaximin for 3 days and then receiving fecal microbiota transplantation) and follow-up until 6 months after the first treatment.

Official Title
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Efficacy and Safety Evaluation of Rifaximin Combined Fecal Microbiota Transplantation in the Treatment of Irritable Bowel Syndrome With Predominant Diarrhea

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Rifaximin
* Procedure: Fecal microbiota transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65, no gender limitation; Had received a diagnosis of IBS-D (as assessed according to the Rome III diagnosis criteria of IBS) and had undergone a colonoscopic examination within the previous 2 years with no organic lesions observed; Has current symptoms of IBS-D: ①Abdominal pain (at least 2 days in a week with no limitation of severity); ②Stool consistency (rated the consistency of their stools of Bristol types 6/7 at least once a day and at least 2 days in a week); Can do follow-up at required time points and signed written informed consent before the study. Exclusion Criteria: Allergic to rifaximin; Taking alosetron, tegaserod, lubiprostone, warfarin, or antipsychotic, antispasmodic, antidiarrheal, probiotic, or narcotic drugs within the previous 1 month; Had infective diarrhea history or had taken antibiotics within the previous 14 days; Patients with a history of inflammatory bowel disease ; Previous abdominal surgery (other than cholecystectomy or appendectomy); Human immunodeficiency virus infection or other immunodeficiency conditions such as congenital immunodeficiency or currently taking immune-suppression drugs; Unstable diabetes, hypertension, thyroid disease, etc; Accompanied malignant tumor or severe heart/lung/renal/hepatic/brain/blood diseases; Accompanied severe neural/psychotic diseases such as epilepsy, depression, mania, schizophrenia, etc; Other conditions that doctor thought not suitable for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Combining therapy<br>taking rifaximin for 3 days and then receiving fecal microbiota transplantation with donor stool through enteral nutrition tube | Drug: Rifaximin<br>* 400mg tid* 3d<br>* Other names: Brand name: XIFAXAN; Production company: SALIX PHARMS;Procedure: Fecal microbiota transplantation<br>* Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with relief of IBS condition | The responder should at the same time get relief of at least one item of abdominal discomfort related symptoms(including abdominal pain score(0-10 with 0 indicates no pain and 10 indicates very great deal of pain) and bloating/abdominal discomfort score(0-10 with 0 indicates no discomfort and 10 indicates very great deal of discomfort), both items' effectiveness are defined as decreasing at least 30% compared with baseline) and at least one item of defecation related abnomalities(including average daily defecation(effectiveness defined as decreasing at least 30% compared with baseline) and stool consistency(effectiveness defined as feces could reach at least Bristol type 5) ). | 6 months after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with relief of IBS related anxiety or depression status | The number of patients who have at least 30% decreasing compared with baseline in the score of SAS/SDS/HADS rating scale | 1 month/2 month/3 month/6 month after the treatment | 
| Number of patients with relief of IBS single symptoms | The number of patients who have relief of IBS global score(0-10 with 0 indicates no discomfort and 10 indicates very great deal of discomfort), pain score(0-10 with 0 indicates no pain and 10 indicates very great deal of pain), bloating/abdominal discomfort score(0-10 with 0 indicates no discomfort and 10 indicateds very great deal of discomfort), urgency score(0-3 with 0 indicates no urgency and 3 indicates great deal of urgency), average daily defecation, stool consistency(according to Bristol criteria). Except stool consistency, other items' effectiveness are defined as decreasing at least 30% compared with baseline during the whole period of follow-up. Stool consistency's effectiveness is defined as feces could reach at least Bristol type 5 during the whole period of follow-up. | 2 week/1 month/2 month/3 month/6 month after the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rifaximin, Fecal microbiota transplantation, Gut microbiota