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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-07-31

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 .

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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 .

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laxative-probiotic sequential

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

Group Type EXPERIMENTAL

Probiotic Clostridium Butyricum

Intervention Type DRUG

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

Laxative Polyethylene Glycol

Intervention Type DRUG

laxative：2000 ml.

probiotic

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

Group Type ACTIVE_COMPARATOR

Probiotic Clostridium Butyricum

Intervention Type DRUG

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

Laxative followed by Probiotic 2 weeks later

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

Group Type ACTIVE_COMPARATOR

Probiotic Clostridium Butyricum

Intervention Type DRUG

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

Laxative Polyethylene Glycol

Intervention Type DRUG

laxative：2000 ml.

Interventions

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Probiotic Clostridium Butyricum

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

Intervention Type DRUG

Laxative Polyethylene Glycol

laxative：2000 ml.

Intervention Type DRUG

Other Intervention Names

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Clostridium Butyricum Tablets Polyethylene Glycol Electrolytes Powder.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No