Clinical trial NCT04662957: Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome
Official title: The Effectiveness of Multi Strain Probiotic Preparation in Patients With Diarrhea Predominant Irritable Bowel Syndrome - Randomized Double Blide Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome With Diarrhea
Effects of Probiotics
Lead sponsor: Children's Memorial Health Institute, Poland
Sponsor class: OTHER
Collaborators: name: Medical University of Lublin
First posted: 2020-12-10
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits without any structural abnormalities. Despite extensive research, the pathogenesis of IBS has not been clearly elucidated yet. Recent studies have shown that disturbed gut microbiota may promote the development and maintenance of IBS. Significant changes in the microbial communities of healthy controls vs IBS patients have been reported in several studies. These findings promoted the research on probiotics for the treatment of IBS. Probiotics are live microorganisms which, when administered at the right dose, have a positive effect on human health. The currently published systemic reviews and meta-analyses of randomized clinical trials have indicated that probiotics have beneficial clinical effects and can help to reduce global and specific IBS symptoms significantly. However, the effect depends on the specific composition of the probiotic preparation, and some meta-analyzes indicate that multi-strain preparations are more effective than single-strain preparations. Therefore, further research is highly anticipated. The purpose of the current clinical trial is to assess the effectiveness of multi-strain probiotic preparation in patients with diarrhea predominant IBS (IBS-D).


Eligibility criteria: 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

Primary outcomes:
measure: Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)
timeFrame: From baseline at 4 and 8 weeks of intervention
measure: Improvement or worsening of IBS global symptoms using Global Improvement Scale (IBS-GIS)
timeFrame: From baseline at 4 and 8 weeks of intervention
measure: Changes in adequate relief of IBS symptoms (IBS-AR)
timeFrame: From baseline at 4 and 8 weeks of intervention
Secondary outcomes:
measure: Changes in type of stools
timeFrame: From baseline for 8 weeks of intervention
measure: Changes in number of bowel movements per day
timeFrame: From baseline for 8 weeks of intervention
measure: Changes in severity of pain
timeFrame: From baseline for 8 weeks of intervention
measure: Changes in flatulence
timeFrame: From baseline for 8 weeks of intervention
measure: Changes in feeling of incomplete evacuation of stool
timeFrame: From baseline for 8 weeks of intervention
measure: Changes in the occurrence of adverse events
timeFrame: From baseline for 8 weeks of intervention
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Children's Memorial Health Institute
Study officials:
References:
citation: 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.