Irritable Bowel SyndromePhase 4NCT03251625
Multi-strain Probiotic in the Management of IBS-D
A Phase 4 study testing Probiotic Formula Capsule in people with Irritable Bowel Syndrome, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Probiotic Formula Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Apr 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
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
- 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
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Probiotic Formula Capsule
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Formula CapsuleDrug
| Study group | Role | What they receive |
|---|---|---|
| To assess the effect of multistrain probiotics on abdominal | Placebo comparator | To assess the effect of multistrain probiotics on abdominal pain using a validated symptom severity score in IBS patients. Receives: Drug: Probiotic Formula Capsule |
| To assess the efficacy of a multistrain probiotic supplement | Placebo comparator | To assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre Receives: Drug: Probiotic Formula Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study startApr 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a randomized, double-blind, placebo-controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S M khosruzzaman, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Ashton Harper, MRCS, Study director, Probiotics International Ltd (Protexin)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251625
- Sponsor's protocol ID
- No. BSMMU/2015/1011
- Status last verified
- Feb 2018
- First submitted
- 9 Aug 2017
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After completion of paper.
Publications
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.
PubMed 29801486
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03251625
- Acronym / sponsor ID
- No. BSMMU/2015/1011
- Conditions
- Irritable Bowel Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- a randomized, double-blind, placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| To assess the effect of multistrain probiotics on abdominal | Placebo comparator | Drug: Probiotic Formula CapsuleTo 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 | Placebo comparator | Drug: Probiotic Formula CapsuleTo assess the efficacy of a multistrain probiotic supplement as a treatment option for IBS in a tertiary referral centre |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Formula Capsule | Drug | To assess the effect of multistrain probiotics on abdominal, To assess the efficacy of a multistrain probiotic supplement |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 29801486Ishaque 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.
- Individual participant dataSharing planned: Undecided. After completion of paper.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
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Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashton Harper, MRCS study director
Probiotics International Ltd (Protexin)
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Probiotic Formula Capsule in people with Irritable Bowel Syndrome, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in severity and frequency of abdominal pain during treatment with a multi-strain probiotic or placebo (time frame: 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.