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

August 30, 2016 updated by: Yanqing Li, Shandong University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Department of Gastroenterology, Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laxative-probiotic sequential
laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy
Drug: Probiotic Clostridium Butyricum
probiotic:2 tablets/ times, 3 times / day for 2 weeks
Other Names:
  • Clostridium Butyricum Tablets
Drug: Laxative Polyethylene Glycol
laxative：2000 ml.
Other Names:
  • Polyethylene Glycol Electrolytes Powder.
Active Comparator: probiotic
Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks.
Drug: Probiotic Clostridium Butyricum
probiotic:2 tablets/ times, 3 times / day for 2 weeks
Other Names:
  • Clostridium Butyricum Tablets
Active Comparator: 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.
Drug: Probiotic Clostridium Butyricum
probiotic:2 tablets/ times, 3 times / day for 2 weeks
Other Names:
  • Clostridium Butyricum Tablets
Drug: Laxative Polyethylene Glycol
laxative：2000 ml.
Other Names:
  • Polyethylene Glycol Electrolytes Powder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject's Global Assessment of Relief
Time Frame: 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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The changes of symptom scores
Time Frame: 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.
8 months
IBS patients'quality of life
Time Frame: 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.
8 months
Composition of Microorganisms in stool
Time Frame: 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).
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Yanqing Li, MD.PhD, Qilu Hospital，Shandong University
  • Principal Investigator: Yanqing Li, MD.PhD., Qilu Hospital, Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 28, 2014

First Submitted That Met QC Criteria

October 1, 2014

First Posted (Estimate)

October 2, 2014

Study Record Updates

Last Update Posted (Estimate)

August 31, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014SDU-QILU-G04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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