NCT Number: NCT03251625
Multi-strain Probiotic in the Management of IBS-D
1. To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients. 2. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for IBS in a tertiary referral centre
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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Diagnosed case of IBS using Rome III criteria
- Absence of red flag sign: anemia, fever, wt loss, per rectal bleeding, nocturnal frequency, family history of inflammatory bowel disease (IBD), cancer
- Age 18-55 years
- No probiotics used in prior 3 months.
- Agreed not to start any other drug unless clinically indicated.
- No antibiotics in previous 2 months of enrolment.
Exclusion criteria
- Age<18 or >55 years
- Previous treatment with probiotics within last 3 months
- Pregnant or lactating females
- Concurrent severe illness (Uncontrolled diabetes mellitus, Renal Dysfunction, Liver disease, hyper and hypothyroidism)
- Chronic organic bowel disorders e.g. inflammatory bowel diseases, tuberculosis, Diverticular disease etc
- Any previous gastrointestinal surgery
Treatment and study plan
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Other
Registry information
Official study 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
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Aug 16, 2017
- Registry last updated
- Feb 5, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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