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

Phase 1

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Probiotic Clostridium Butyricum; Drug: Laxative Polyethylene Glycol

• Registration Number: NCT02254629
• Lead Sponsor: Shandong University

Brief Summary

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

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-10-01
• Study First Posted: 2014-10-02
• Primary Completion: 2015-08
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laxative-probiotic sequential	Probiotic Clostridium Butyricum	laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy
probiotic	Probiotic Clostridium Butyricum	Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks.
Laxative followed by Probiotic 2 weeks later	Probiotic Clostridium Butyricum	laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy.
laxative-probiotic sequential	Laxative Polyethylene Glycol	laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy
Laxative followed by Probiotic 2 weeks later	Laxative Polyethylene Glycol	laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy.

Primary Outcome Measures

Name	Time	Method
Subject's Global Assessment of Relief	8 months	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.

Secondary Outcome Measures

Name	Time	Method
The changes of symptom scores	8 months	The symptom score includes abdominal pain, discomfort, bloating, stool frequency, stool consistency according to Bristol stool form scale and defecation urgency，imcomplete，straining.
IBS patients'quality of life	8 months	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.
Composition of Microorganisms in stool	8 months	Primary coordination of fecal samples' 16s rDNA (ribosomal deoxyribonucleic acid) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China