Irritable Bowel Syndrome
Conditions
Brief summary
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
Detailed description
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.
Interventions
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Participants divided into two groups by randomization software, consisting of 200 in each group.
Intervention model description
a randomized, double-blind, placebo-controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed case of IBS using Rome III criteria 2. Absence of red flag sign: anemia, fever, wt loss, per rectal bleeding, nocturnal frequency, family history of inflammatory bowel disease (IBD), cancer 3. Age 18-55 years 4. No probiotics used in prior 3 months. 5. Agreed not to start any other drug unless clinically indicated. 6. No antibiotics in previous 2 months of enrolment.
Exclusion criteria
1. Age\<18 or \>55 years 2. Previous treatment with probiotics within last 3 months 3. Pregnant or lactating females 4. Concurrent severe illness (Uncontrolled diabetes mellitus, Renal Dysfunction, Liver disease, hyper and hypothyroidism) 5. Chronic organic bowel disorders e.g. inflammatory bowel diseases, tuberculosis, Diverticular disease etc 6. Any previous gastrointestinal surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo | 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. |
Outcome results
None listed