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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254629
• Other study ID #: 2014SDU-QILU-G04
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2014
• Last updated: August 30, 2016
• Start date: July 2014
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Probiotic Clostridium Butyricum
probiotic:2 tablets/ times, 3 times / day for 2 weeks
• Laxative Polyethylene Glycol
laxative:2000 ml.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No