Back to resultsThe Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Probiotic Clostridium Butyricum
Laxative Polyethylene Glycol
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Fecal microflora, IBS, Sequential treatment, Probiotic, Laxative
Eligibility Criteria
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
Sites / Locations
- Department of Gastroenterology, Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
laxative-probiotic sequential
probiotic
Laxative followed by Probiotic 2 weeks later
Arm Description
laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy
Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks.
laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02254629
Brief Title
The Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients
Official Title
The Effects of Laxative-probiotic Sequential Treatment on the Symptoms and Fecal Microbiota in the IBS Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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 .
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Fecal microflora, IBS, Sequential treatment, Probiotic, Laxative
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laxative-probiotic sequential
Arm Type
Experimental
Arm Description
laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks，immediately after colonoscopy
Arm Title
probiotic
Arm Type
Active Comparator
Arm Description
Probiotic：2 tablets/ times, 3 times / day for the first 2 weeks.
Arm Title
Laxative followed by Probiotic 2 weeks later
Arm Type
Active Comparator
Arm Description
laxative：2000 ml. Probiotic：2 tablets/ times, 3 times / day for the last 2 weeks with two weeks interval after colonoscopy.
Intervention Type
Drug
Intervention Name(s)
Probiotic Clostridium Butyricum
Other Intervention Name(s)
Clostridium Butyricum Tablets
Intervention Description
probiotic:2 tablets/ times, 3 times / day for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Laxative Polyethylene Glycol
Other Intervention Name(s)
Polyethylene Glycol Electrolytes Powder.
Intervention Description
laxative：2000 ml.
Primary Outcome Measure Information:
Title
Subject's Global Assessment of Relief
Description
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.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
The changes of symptom scores
Description
The symptom score includes abdominal pain, discomfort, bloating, stool frequency, stool consistency according to Bristol stool form scale and defecation urgency，imcomplete，straining.
Time Frame
8 months
Title
IBS patients'quality of life
Description
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.
Time Frame
8 months
Title
Composition of Microorganisms in stool
Description
Primary coordination of fecal samples' 16s rDNA (ribosomal deoxyribonucleic acid) will be compared between two Groups using Braycurtis distance based Primary coordination analysis (PCoA).
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD.PhD
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yanqing Li, MD.PhD.
Organizational Affiliation
Qilu Hospital, Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
33168839
Citation
Li M, Xu R, Li YQ. Sequential laxative-probiotic usage for treatment of irritable bowel syndrome: a novel method inspired by mathematical modelling of the microbiome. Sci Rep. 2020 Nov 9;10(1):19291. doi: 10.1038/s41598-020-75225-z.
Results Reference
derived
Learn more about this trial
The Effects of Laxative-probiotic Sequential Treatment in the Irritable Bowel Syndrome Patients
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