NCT04662957

Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome

The Effectiveness of Multi Strain Probiotic Preparation in Patients With Diarrhea Predominant Irritable Bowel Syndrome - Randomized Double Blide Placebo Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Children's Memorial Health Institute, Poland · Academic / Other
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Irritable Bowel Syndrome With Diarrhea
• Effects of Probiotics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo	Oral supplementation with multi-strain probiotic preparation
DIETARY_SUPPLEMENT	Maltodextrin	Maltodextrin as placebo

Timeline

• Start date: 2019-11-02
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2020-12-10
• Last updated: 2020-12-16

Locations

1 site across 1 country: Poland