Irritable Bowel SyndromePhase 2IBS2NCT01475929
Effect of Probiotic Supplement on Bowel Function
A Phase 2 study testing Probiotic supplement in people with Irritable Bowel Syndrome, run by Danisco at 1 site in Finland.
Trial summary
The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Probiotic supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2011to May 2012
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged 18 to 65 with functional bowel symptoms and fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.
Who cannot join
- Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health are exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.
Read the detailed description
The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Probiotic supplement
- Keywords
- irritable bowel syndrome, probiotic
- 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 supplementDietary supplement
Also called Lactobacillus
A single strain probiotic supplement given at two doses
| Study group | Role | What they receive |
|---|---|---|
| Probiotic low | Active comparator | Lower dose of probiotic supplement Receives: Dietary Supplement: Probiotic supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Probiotic supplement |
| Probiotic high | Active comparator | Higher dose of probiotic supplement Receives: Dietary Supplement: Probiotic supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional bowel symptoms
Validated questionnaire
Measured: 0 weeks, 6 weeks, 12 weeks
Secondary outcomes (3)
Change in quality of life
Validated questionnaire
Measured: 0 weeks, 6 weeks, 12 weeks
Adequate relief
Weekly question
Measured: Weekly over 3 month intervention
Change in faecal microbiota
Quantification of selected microbes and the intervention strain from faecal samples
Measured: 0 weeks, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Why it stopped: Protocol violations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arthur Ouwehand, PhD, Study chair, DaniscoAnna Lyra, PhD, Study director, DaniscoLea Veijola, MD, Principal investigator, Helsinki Health CentreSampo Lahtinen, PhD, Study chair, DaniscoAnneli Tarpila, PhD, Study director, Danisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475929
- Sponsor's protocol ID
- IBS2
- Acronym
- IBS2
- Status last verified
- Aug 2015
- First submitted
- 20 Sep 2011
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Supplement on Bowel Function
- ClinicalTrials.gov ID
- NCT01475929
- Acronym / sponsor ID
- IBS2 / IBS2
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, probiotic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol violations
- Enrolment
- 149 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 22 Nov 2011 (estimated)
- 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.
The purpose of this study is to analyse the effect of probiotic supplement on symptoms of irritable bowel syndrome.
Detailed description
The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on symptoms of irritable bowel syndrome (IBS). Fulfillment of Rome III criteria will be used as inclusion criterion. Subjective assessment of bowel symptoms, IBS-related quality of life and adequate relief will be assessed as outcome measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic low | Active comparator | Dietary Supplement: Probiotic supplementLower dose of probiotic supplement |
| Placebo | Placebo comparator | Dietary Supplement: Probiotic supplement |
| Probiotic high | Active comparator | Dietary Supplement: Probiotic supplementHigher dose of probiotic supplement |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects aged 18 to 65 with functional bowel symptoms and fulfilling Rome III criteria for IBS will be recruited. Sufficient general health and orientation for participating in the study is required and will be evaluated by the MDs.
Key exclusion criteria (1 listed)
- Diagnosed or suspected organic gastrointestinal diseases or severely impaired general health are exclusion criteria.
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 supplementAlso: LactobacillusA single strain probiotic supplement given at two doses | Dietary supplement | Placebo, Probiotic high, Probiotic low |
Primary outcome
Change in functional bowel symptoms
Time frame: 0 weeks, 6 weeks, 12 weeks
Validated questionnaire
3 secondary outcomes
Change in quality of life
Time frame: 0 weeks, 6 weeks, 12 weeks
Adequate relief
Time frame: Weekly over 3 month intervention
Change in faecal microbiota
Time frame: 0 weeks, 6 weeks, 12 weeks
Results and safety
The study was stopped early (reason given: Protocol violations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2015.
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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.
Arthur Ouwehand, PhD study chair
Danisco
Anna Lyra, PhD study director
Danisco
Lea Veijola, MD principal investigator
Helsinki Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic supplement in people with Irritable Bowel Syndrome, run by Danisco at 1 site in Finland.
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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 13 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Protocol violations). Results are not available in the source record.
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?
Change in functional bowel symptoms (time frame: 0 weeks, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2015.