Multi-strain Probiotic in the Management of IBS-D

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Drug: Probiotic Formula Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT03251625

No. BSMMU/2015/1011

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

To assess the effect of multistrain probiotics on abdominal

Placebo Comparator group

Description:

To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.

Treatment:

Drug: Probiotic Formula Capsule

To assess the efficacy of a multistrain probiotic supplement

Placebo Comparator group

Description:

To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre

Treatment:

Drug: Probiotic Formula Capsule