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

Shandong University56 enrolled

Overview

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

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 .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Irritable Bowel Syndrome

Interventions

Probiotic Clostridium ButyricumDRUG

probiotic:2 tablets/ times, 3 times / day for 2 weeks

Laxative Polyethylene GlycolDRUG

laxative：2000 ml.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

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.

Time frame: 8 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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).

Time frame: 8 months

Data from ClinicalTrials.gov

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