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

Shandong University

Status and phase: Completed; Phase 1

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Laxative Polyethylene Glycol; Drug: Probiotic Clostridium Butyricum

Study type: Interventional

Funder types: Other

Identifiers

NCT02254629

2014SDU-QILU-G04

Details and patient eligibility

About

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

Full 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 .

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 3 patient groups

laxative-probiotic sequential

Experimental group

Description:

laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy

Treatment:

Drug: Probiotic Clostridium Butyricum

Drug: Laxative Polyethylene Glycol

probiotic

Active Comparator group

Description:

Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks.

Treatment:

Drug: Probiotic Clostridium Butyricum

Laxative followed by Probiotic 2 weeks later

Active Comparator group

Description:

laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy.

Treatment:

Drug: Probiotic Clostridium Butyricum

Drug: Laxative Polyethylene Glycol