The Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients

Study Overview
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Brief Summary
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the laxative-probiotic sequential treatment might reduce the symptoms of IBS and alter the fecal microbiota of the patients in a more robust manner .

Detailed Description
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Probiotics can regulate intestinal immunity, repair mucosal barrier, and reportedly exert therapeutic effects on IBS patients. The laxatives could also alter the gut microflora significantly, thus the laxative-probiotic sequential treatment might affect the symptoms and the composition of fecal microbiota in the IBS patients in a more robust manner .

Official Title
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The Effects of Laxative-probiotic Sequential Treatment on the Symptoms and Fecal Microbiota in the IBS Patients.

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Probiotic Clostridium Butyricum
* Drug: Laxative Polyethylene Glycol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the presence of Rome III criteria for IBS ; Patients scheduled for colonoscopy examination or having negative screening examinations Aged between 18 and 65 years old Exclusion Criteria: Antibiotic, probiotic or laxative usage within 4 weeks. organic gastrointestinal diseases Severe systematic disease: diabetes mellitus, hepatic, renal or cardiac dysfunction, thyroid disease or tumor etc. pregnancy or lactation. previous major or complicated abdominal surgery. severe endometriosis and dementia

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: laxative-probiotic sequential<br>laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy | Drug: Probiotic Clostridium Butyricum<br>* probiotic:2 tablets/ times, 3 times / day for 2 weeks<br>* Other names: Clostridium Butyricum Tablets;Drug: Laxative Polyethylene Glycol<br>* laxative：2000 ml.<br>* Other names: Polyethylene Glycol Electrolytes Powder.;|
| Active Comparator: probiotic<br>Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks. | Drug: Probiotic Clostridium Butyricum<br>* probiotic:2 tablets/ times, 3 times / day for 2 weeks<br>* Other names: Clostridium Butyricum Tablets;|
| Active Comparator: Laxative followed by Probiotic 2 weeks later<br>laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy. | Drug: Probiotic Clostridium Butyricum<br>* probiotic:2 tablets/ times, 3 times / day for 2 weeks<br>* Other names: Clostridium Butyricum Tablets;Drug: Laxative Polyethylene Glycol<br>* laxative：2000 ml.<br>* Other names: Polyethylene Glycol Electrolytes Powder.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject's Global Assessment of Relief | The SGA (subjective global assessment) of Relief was assessed by answering the following question: Please consider how you felt this past week in regard to your IBS, in particular your overall wellbeing, symptoms and altered bowel habit. Compared to the way you usually felt before entering the study, how would you rate your relief of symptoms during the past week? The scale contained five possible answers: (1) completely relieved, (2) considerably relieved, (3) somewhat relieved, (4) unchanged, or (5) worse. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The changes of symptom scores | The symptom score includes abdominal pain, discomfort, bloating, stool frequency, stool consistency according to Bristol stool form scale and defecation urgency，imcomplete，straining. | 8 months | 
| IBS patients'quality of life | Quality of life was determined by using IBS-QOL scoring system for patients with IBS. This questionnaire comprises a range of 34 items with response options on a 5-point rating scale. The items contribute to 8 domains as follows: Dysphoria, Interference with activity, Body image, Health worry, Food avoidance, Social reaction, Sexual, Relationship. | 8 months | 
| Composition of Microorganisms in stool | Primary coordination of fecal samples' 16s rDNA (ribosomal deoxyribonucleic acid) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA). | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal microflora, IBS, Sequential treatment, Probiotic, Laxative