- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04662957
Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome
The Effectiveness of Multi Strain Probiotic Preparation in Patients With Diarrhea Predominant Irritable Bowel Syndrome - Randomized Double Blide Placebo Controlled Study
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Warsaw, Poland, 04-730
- The Children's Memorial Health Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- diarrhea-predominant irritable bowel syndrome (IBS-D)
- at least moderate form of IBS-D assessed using IBS-SSS, i.e. with score >175
- male and female subjects of Caucasian race
- age between 16 and 70 years (inclusive)
- good physical, medical and mental status estimated on the basis of the medical history and a general clinical examination
- results of laboratory tests (hematology, clinical chemistry, serology, and urinalysis) within the normal range of the local laboratory or considered non-clinically significant by the investigator
- patients who have provided freely their own written informed consent
- patients available for the whole study period
- patients who are able to follow strictly the instructions of the investigational team regarding the study procedures and to fulfil the requirements of the protocol
- the following medications are permitted during the course of the study, as long as they are used at a constant dosage and are commenced at least 1 month prior to study start: birth control pill, or depot intramuscular contraceptive preparation, estrogen-progesterone replacement therapy, L-thyroxine, low-dose antidepressants (up to 25 mg day of amitriptyline, nortriptyline, or selective serotonin reuptake inhibitor), low-dose antihypertensives in the diuretic, angiotensin-converting enzyme inhibitor or angiotensin II inhibitor classes
- patients are allowed to take spasmolytic drugs on an ad hoc basis
Exclusion Criteria:
- other than IBD-D types of IBD
- mild type of IBS-D (<175 points in IBS-SSS scale)
- the use of probiotics within last three months
- the treatment with antibiotics within last three months
- a concurrent severe illness (malignancies, uncontrolled hypertension and diabetes mellitus, hepatic, renal or cardiac dysfunctions, serious neurological disorders, psychosis, respiratory disorders such as asthma, chronic obstructive pulmonary disease, hyper- or hypothyroidism)
- chronic bowel disorders other than IBS, including inflammatory bowel diseases, gastroenteritis, stomach and duodenal ulcers, celiac diseases;
- pregnancy or lactation
- diagnosed lactose intolerance
- the use of motility drugs or dietary fiber supplements within 2 weeks before study start
- plan to have surgery during the time of the study
- a history of alcohol or drug abuse
- taking anti-coagulant medications
- participation in another clinical trial within last three months
- patients who will receive antibiotics during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Probiotic preparation
Multi-strain probiotic mixture.
The daily dose was five billion (2 capsules/day).
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Oral supplementation with multi-strain probiotic preparation
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PLACEBO_COMPARATOR: Maltodextrin
Maltodextrin comparable in color, texture and taste to the probiotic mixture (2 capsules/day).
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Maltodextrin as placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)
Time Frame: From baseline at 4 and 8 weeks of intervention
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IBS-Severity Scoring System is a 5-question survey that asks: 1. the severity of abdominal pain, 2. frequency of abdominal pain, 3. severity of abdominal distention, 4.dissatisfaction with bowel habit, and 5. interference with quality of life over the past 10 days.
Subjects respond to each question on a 100-point visual analogue scale.
Each of the five question generates a maximum score of 100 point, and total scores can range from 0-500 with higher scores indicating severe symptoms.
A decrease of 30 points is associated with a clinically meaningful improvement.
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From baseline at 4 and 8 weeks of intervention
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Improvement or worsening of IBS global symptoms using Global Improvement Scale (IBS-GIS)
Time Frame: From baseline at 4 and 8 weeks of intervention
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IBS-Global Improvement Scale asseses IBS symptoms using a patient-defined 7 point Linkert scale ranging from symptoms substantially worse to substantially improved. Patients answer the question "Have you felt any change in the severity of your symptoms over the past 7 days compared to how you felt before the medicine was given? The answers are recorded based on the 7-point scale:
IBS-GIS score indicates: improvement if is >4 or worsening if is<4, no change if is 4 |
From baseline at 4 and 8 weeks of intervention
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Changes in adequate relief of IBS symptoms (IBS-AR)
Time Frame: From baseline at 4 and 8 weeks of intervention
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IBS-Adequate Relief (IBS-AR) is a dichotomous single item that asks participants "Over the past week (7 days) have you had adequate relief of your IBS symptoms?
The answer is YES or NO.
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From baseline at 4 and 8 weeks of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in flatulence
Time Frame: From baseline for 8 weeks of intervention
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The severity of flatulence assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no flatulence, and points1-4 with higher scores indicating worse flatulence
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From baseline for 8 weeks of intervention
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Changes in feeling of incomplete evacuation of stool
Time Frame: From baseline for 8 weeks of intervention
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The severity of incomplete evacuation of stool assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no feeling of incomplete evacuation of stool, and points1-4 with higher scores indicating worse feeling of incomplete evacuation of stool
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From baseline for 8 weeks of intervention
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Changes in type of stools
Time Frame: From baseline for 8 weeks of intervention
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ype of stool assessed before intervention and then 3 times a week.
Type of stools assessed using the Bristol Stool Scale.
Bristol Scale is designed to classify faeces into seven groups: type 1-2 indicate constipation, type 3-4 are "normal" stools; type 5-7 indicate diarrhea.
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From baseline for 8 weeks of intervention
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Changes in number of bowel movements per day
Time Frame: From baseline for 8 weeks of intervention
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Number of bowel movements per day assessed before intervention and then 3 times a week
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From baseline for 8 weeks of intervention
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Changes in severity of pain
Time Frame: From baseline for 8 weeks of intervention
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The severity of pain assessed before intervention and then 3 times a week using a patient-defined 5 point Linkert scale: point 0 - no pain, and 1-4 the severity of pain with higher scores indicating worse pain
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From baseline for 8 weeks of intervention
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Changes in the occurrence of adverse events
Time Frame: From baseline for 8 weeks of intervention
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The number and the type of adverse events assessed before intervention and then 3 times a weeks.
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From baseline for 8 weeks of intervention
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Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MBX02/2019/P
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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