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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014SDU-QILU-G04

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