Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome
NCT ID: NCT04662957
Last Updated: 2020-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2019-11-02
2020-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Probiotic preparation
Multi-strain probiotic mixture. The daily dose was five billion (2 capsules/day).
Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo
Oral supplementation with multi-strain probiotic preparation
Maltodextrin
Maltodextrin comparable in color, texture and taste to the probiotic mixture (2 capsules/day).
Maltodextrin
Maltodextrin as placebo
Interventions
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Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo
Oral supplementation with multi-strain probiotic preparation
Maltodextrin
Maltodextrin as placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
70 Years
ALL
No
Sponsors
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Medical University of Lublin
OTHER
Children's Memorial Health Institute, Poland
OTHER
Responsible Party
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Bożena Cukrowska
Prof. MD, PhD
Locations
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The Children's Memorial Health Institute
Warsaw, , Poland
Countries
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References
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Skrzydlo-Radomanska B, Prozorow-Krol B, Cichoz-Lach H, Majsiak E, Bierla JB, Kanarek E, Sowinska A, Cukrowska B. The Effectiveness and Safety of Multi-Strain Probiotic Preparation in Patients with Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Controlled Study. Nutrients. 2021 Feb 26;13(3):756. doi: 10.3390/nu13030756.
Other Identifiers
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MBX02/2019/P
Identifier Type: -
Identifier Source: org_study_id