An interventional study of Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo and Maltodextrin in Irritable Bowel Syndrome With Diarrhea and Effects of Probiotics, sponsored by Children's Memorial Health Institute, Poland. Completed at 1 site in Poland. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-16.
Sponsored by Children's Memorial Health Institute, Poland · Not applicable, Interventional, and Treatment
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).
Exclusion Criteria:
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 comparable in color, texture and taste to the probiotic mixture (2 capsules/day).
Dietary Supplement: Maltodextrin
Oral supplementation with multi-strain probiotic preparation
Maltodextrin as placebo
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.
Time frame: 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: 1. I feel that the symptoms have worsened significantly 2. I feel that the symptoms have moderately worsened 3. I feel that the symptoms have slightly worsened 4. I feel no change 5. I feel a slight improvement 6. I feel moderate improvement 7. I feel significant improvement IBS-GIS score indicates: improvement if is \>4 or worsening if is\<4, no change if is 4
Time frame: 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.
Time frame: From baseline at 4 and 8 weeks of intervention
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.
Time frame: From baseline for 8 weeks of intervention
Changes in number of bowel movements per day
Number of bowel movements per day assessed before intervention and then 3 times a week
Time frame: From baseline for 8 weeks of intervention
Changes in severity of pain
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
Time frame: From baseline for 8 weeks of intervention
Changes in flatulence
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
Time frame: From baseline for 8 weeks of intervention
Changes in feeling of incomplete evacuation of stool
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
Time frame: From baseline for 8 weeks of intervention
Changes in the occurrence of adverse events
The number and the type of adverse events assessed before intervention and then 3 times a weeks.
Time frame: From baseline for 8 weeks of intervention
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Children's Memorial Health Institute, Poland