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Multi-strain Probiotic in the Management of IBS-D

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03251625
Recruitment Status : Completed
First Posted : August 16, 2017
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
S M khosruzzaman, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Probiotic Formula Capsule Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abdominal Pain

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Investigators
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Study Director: Ashton Harper, MRCS Probiotics International Ltd (Protexin)
  Study Documents (Full-Text)

Documents provided by S M khosruzzaman, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh:
Study Protocol  [PDF] August 2, 2015

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: S M khosruzzaman, Principal Investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
ClinicalTrials.gov Identifier: NCT03251625    
Other Study ID Numbers: No. BSMMU/2015/1011
First Posted: August 16, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: After completion of paper.

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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
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases