Multi-strain Probiotic in the Management of IBS-D
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|ClinicalTrials.gov Identifier: NCT03251625|
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : February 5, 2018
- To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.
- To assess the efficacy of a multi-strain probiotic supplement as a treatment option for IBS in a tertiary referral centre
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: Probiotic Formula Capsule||Phase 4|
Background: Accumulating evidence supports the view that an imbalance of gut bacteria contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers of pathogenic bacteria and help alleviate symptoms.
Methods: In this double-blind trial 360 adult patients with moderate-to-severe symptomatic diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic (Bio-Kult®; 14 different bacterial strains; 8 billion colony-forming units per day) or placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary outcome measure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||a randomized, double-blind, placebo-controlled clinical trial|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Participants divided into two groups by randomization software, consisting of 200 in each group.|
|Official Title:||Supplementation With a Multi-strain Probiotic Formulation (Bio-Kult®) in the Management of Diarrhea-predominant Irritable Bowel Syndrome - a Randomized, Double-blind, Placebo-controlled Clinical Trial|
|Actual Study Start Date :||April 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Placebo Comparator: To assess the effect of multistrain probiotics on abdominal
To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.
Drug: Probiotic Formula Capsule
Placebo Comparator: To assess the efficacy of a multistrain probiotic supplement
To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre
Drug: Probiotic Formula Capsule
- The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo [ Time Frame: 1 year. ]The change in severity and frequency of abdominal pain as measured by IBS-Symptom Severity Scores during treatment with a multi-strain probiotic or placebo, and compared with baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03251625
|Study Director:||Ashton Harper, MRCS||Probiotics International Ltd (Protexin)|