Multi Strain Probiotic Preparation in Patients With Irrit... | NCT04662957

Status Module

Name	Class
Medical University of Lublin	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic preparation	Experimental	Multi-strain probiotic mixture. The daily dose was five billion (2 capsules/day).	Dietary Supplement: Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo
Maltodextrin	Placebo Comparator	Maltodextrin comparable in color, texture and taste to the probiotic mixture (2 capsules/day).	Dietary Supplement: Maltodextrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo	Dietary Supplement	Oral supplementation with multi-strain probiotic preparation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in severity of IBS symptoms using IBS Severity Scoring System (IBS-SSS)	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.	From baseline at 4 and 8 weeks of intervention
Improvement or worsening of IBS global symptoms using Global Improvement Scale (IBS-GIS)	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: I feel that the symptoms have worsened significantly I feel that the symptoms have moderately worsened I feel that the symptoms have slightly worsened I feel no change I feel a slight improvement I feel moderate improvement I feel significant improvement 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
Changes in adequate relief of IBS symptoms (IBS-AR)	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.	From baseline at 4 and 8 weeks of intervention

Secondary Outcomes

Measure	Description	Time Frame
Changes in type of stools	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.	From baseline for 8 weeks of intervention

Eligibility Module

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