- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04206410
Effectiveness of Probiotics Stabilized With Cryoprotection Technology in Patients With Irritable Bowel Syndrome
Evaluation of the Effectiveness of Probiotics Stabilized With Cryoprotection Technology in Patients With Irritable Bowel Syndrome - a Randomized Double-blind, Placebo-controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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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:
- Male and female subjects of Caucasian race
- Age between 16 and 60 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.
- Subjects who have provided freely their own written informed consent.
- Subjects available for the whole study period.
Diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) according to Rome III criteria, i.e. symptoms of recurrent abdominal pain or discomfort* and a marked change in bowel habit with symptoms experienced on at least three days a week of at least three months within last year. Pain/discomfort is related to a change in the appearance of stool, frequency of stool and improves with defecation.
* "Discomfort" means an uncomfortable sensation not described as pain.
The following subjects will be enrolled in the study:
- with diarrhea-predominant irritable bowel syndrome, i.e., persons, who have at least one stool of type 6 or type 7 in Bristol stool score (BSS) over at least 2 days a week
- with at least moderate form assessed using IBS-SSS (5 questions, maximum number of points 500); enrolled subjects with score >175 points Mild <175 points, Moderate 175-300 points, Severe >300 points.
- Subjects 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.
Exclusion Criteria:
- Patients with cardiovascular disorders: uncontrolled hypertension (blood pressure > 170/100 mmHg), cerebrovascular diseases.
- Patients with respiratory disorders (asthma, chronic obstructive pulmonary disease [COPD]).
- Patients with hepatic disorders (including condition following cholecystectomy procedure) and renal disorders as well as abnormal results of biochemical blood tests without diagnosis: serum creatinine > 2 x upper limit of normal, AST or ALT > 2 x upper limit of normal.
- Patients with gastrointestinal disorders other than IBS, including clinically or endoscopic-confirmed gastroenteritis.
- Patients with endocrinological disorders, including patients with diabetes mellitus (fasting blood glucose concentration > 11 mmol/L), and TSH > normal.
- Patients with serious neurological disorders, psychosis.
- Patients with malignancies.
- Pregnant or lactating women.
- Soy hypersensitivity.
- The subject has been diagnosed with lactose intolerance and this can explain their symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet).
- Use of motility drugs or dietary fiber supplements within 2 weeks before study start.
- Patients, taking anti-coagulant medication.
- Plan to have surgery during the time of the study.
- Currently consuming probiotics and refuse to have a three months washout period.
- Recent antibiotic therapy within the last 3 month.
- Patients, who receive antibiotics during the study, will be excluded.
- Patients, enrolled in another clinical trial in the past 3 months.
- The subject has a history of alcohol or substance abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Probiotic
Multistrain probiotic mixture consisting of two Lactobacillus strains (L.
rhamnosus and L. acidophilus) and three Bifidobacterium strains (B.
longum, B. bifidum and B. lactis) administered for 8 weeks in a dose 1,0E+10/day, 2x sachets/day (5,0E+9/cfu per sachet)
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Multispecies probiotic mixture administered to patients according to the randomization list
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Placebo Comparator: Maltodextrin
Placebo - Maltodextrin manufactured with an appearance, taste and packaging (sachets) identical to the probiotic mixture administarted for 8 weeks 2x sachets/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 |
---|---|---|
Improvement or worsening of IBS global symptoms using Global Improvement Scale (IBS-GIS)
Time Frame: Improvement/worsening of global symptoms after 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 |
Improvement/worsening of global symptoms after 4 and 8 weeks of intervention
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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 50 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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Changes in adequate relief of IBS symptoms (IBS-AR)
Time Frame: From baseline at 4 and 8 weeks of interventions
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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 interventions
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Changes in Quality of Life (IBS-QOL)
Time Frame: From baseline at 4 and 8 weeks of intervention
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The IBS-Quality of Life (IBS-QOL) is a 34-item measure assessing the degree to which IBS interferes with patient quality of life.
Each item is rated on a 5-point Likert scale, thus yielding a total score that has a theoretical range of 34 to 170, with higher scores indicating worse QOL.
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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 type of stools
Time Frame: From baseline for 8 weeks of intervention
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Type 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 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 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 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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in serum level of intestinal fatty acid binding protein
Time Frame: From baseline at 8 weeks of intervention
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Intestinal fatty acid binding protein (I-FABP) is a novel serological marker of disrupted enterocytes, and could be an indicator of increased intestinal permeability.
The level is measured in patients' sera using commercially available kits.
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From baseline at 8 weeks of intervention
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bożena Cukrowska, PhD MD, The Children's Memorial Health Institute
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6/KBE/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Irritable Bowel Syndrome
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ProgenaBiomeRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome Characterized by Constipation | Irritable Bowel Syndrome Mixed | Irritable Bowel Syndrome Without Diarrhea | Irritable Bowel | Irritable Bowel Syndrome Aggravated and other conditionsUnited States
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ClasadoCR2O B.V.RecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome - Constipation | Irritable Bowel Syndrome - Diarrhoea | Irritable Bowel Syndrome - MixedBelgium, Netherlands, United Kingdom
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Istanbul Medipol University HospitalTepecik Training and Research Hospital; Bozyaka Training and Research Hospital and other collaboratorsRecruitingIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedTurkey
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Federal Stare Budgetary Scientific Institution,...I.M. Sechenov First Moscow State Medical University; RML INVEST, Torkhovsky...CompletedIrritable Bowel Syndrome | Irritable Bowel Syndrome With Diarrhea | Irritable Bowel Syndrome With Constipation | Irritable Bowel Syndrome MixedRussian Federation
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Vasily IsakovRussian Science Foundation; Azbuka vkusa; Federal Research Centre of Nutrition...CompletedIrritable Bowel Syndrome With Constipation | Constipation-predominant Irritable Bowel SyndromeRussian Federation
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