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Multi-strain Probiotic in the Management of IBS-D

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Probiotic Formula Capsule
Sponsored by
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Placebo Comparator

    Arm Label

    To assess the effect of multistrain probiotics on abdominal

    To assess the efficacy of a multistrain probiotic supplement

    Arm Description

    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 multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre

    Outcomes

    Primary Outcome Measures

    The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 9, 2017
    Last Updated
    February 1, 2018
    Sponsor
    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03251625
    Brief Title
    Multi-strain Probiotic in the Management of IBS-D
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2015 (Actual)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Irritable Bowel Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    a randomized, double-blind, placebo-controlled clinical trial
    Masking
    ParticipantInvestigator
    Masking Description
    Participants divided into two groups by randomization software, consisting of 200 in each group.
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    To assess the effect of multistrain probiotics on abdominal
    Arm Type
    Placebo Comparator
    Arm Description
    To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients.
    Arm Title
    To assess the efficacy of a multistrain probiotic supplement
    Arm Type
    Placebo Comparator
    Arm Description
    To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre
    Intervention Type
    Drug
    Intervention Name(s)
    Probiotic Formula Capsule
    Primary Outcome Measure Information:
    Title
    The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo
    Description
    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.
    Time Frame
    1 year.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ashton Harper, MRCS
    Organizational Affiliation
    Probiotics International Ltd (Protexin)
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    After completion of paper.
    Citations:
    PubMed Identifier
    29801486
    Citation
    Ishaque SM, Khosruzzaman SM, Ahmed DS, Sah MP. A randomized placebo-controlled clinical trial of a multi-strain probiotic formulation (Bio-Kult(R)) in the management of diarrhea-predominant irritable bowel syndrome. BMC Gastroenterol. 2018 May 25;18(1):71. doi: 10.1186/s12876-018-0788-9.
    Results Reference
    derived

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    Multi-strain Probiotic in the Management of IBS-D

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