Irritable Bowel SyndromePhase 2NCT01728610
Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms
A Phase 2 study testing Probiotic (Active high) and Probiotic (Active low) in people with Irritable Bowel Syndrome, run by Danisco at 2 sites in Finland.
Trial summary
The purpose of this study is to analyse the effect of a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS). 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 (Active high) and Probiotic (Active low)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 391 participants
- Where
- 2 sitesFinland
- Study dates
- Oct 2012to Nov 2014
- 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 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.
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Mehiläinen Töölö
Helsinki, Helsinki, 00260
Mehiläinen Turku
Turku, Turku, 20100
About this study
Official title: Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)
The purpose of this study is to analyse the effect of a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).
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 functional intestinal symptoms among subjects diagnosed with IBS according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. The intestinal microbiota will be analysed from faecal samples.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Probiotic (Active high), Probiotic (Active low), Placebo
- Keywords
- irritable bowel syndrome, probiotic, pain, bloating, diarrhoea, constipation
- Medical subject headings
- Irritable Bowel Syndrome, Pain, Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic (Active high)Dietary supplement
Also called Lactobacillus
Higher dose of probiotic supplement
Probiotic (Active low)Dietary supplement
Also called Lactobacillus
Lower dose of probiotic supplement
PlaceboDietary supplement
Also called Maltodextrin as placebo
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active high | Active comparator | Probiotic, high dose Receives: Dietary Supplement: Probiotic (Active high) |
| Active low | Active comparator | Probiotic, low dose Receives: Dietary Supplement: Probiotic (Active low) |
| Placebo | Placebo comparator | Placebo Receives: Dietary Supplement: Placebo |
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, 4 weeks, 12 weeks
Secondary outcomes (5)
Change in quality of life
Validated questionnaire
Measured: 0 weeks, 4 weeks, 12 weeks
Change in anxiety and depression
Validated questionnaire
Measured: 0 weeks, 4 weeks and 12 weeks
Adequate relief
Weekly question
Measured: Weekly over 3 month intervention
Change in faecal microbiota
Detection and quantification of microbes from faecal samples
Measured: 0 weeks, 4 weeks, 12 weeks
Safety of investigational product
Recording of adverse events and serious adverse events
Measured: Throughout the intervention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2014
- Study completionNov 2014
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
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lea Veijola, MD, Principal investigator, Herttoniemi HospitalArthur Ouwehand, PhD, Study chair, DuPont Nutrition and HealthSampo Lahtinen, PhD, Study chair, DuPont Nutrition and HealthAnna Lyra, PhD, Study director, DuPont Nutrition and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01728610
- Sponsor's protocol ID
- IBS-2
- Status last verified
- Jan 2016
- First submitted
- 5 Oct 2012
- Last updated
- 26 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Supplement in Alleviating Functional Gastrointestinal Symptoms (IBS-2)
- ClinicalTrials.gov ID
- NCT01728610
- Acronym / sponsor ID
- IBS-2
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, probiotic, pain, bloating, diarrhoea, constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- DaniscoIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 Nov 2012 (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 a probiotic supplement on functional intestinal symptoms among subjects diagnosed with irritable bowel syndrome (IBS).
Detailed description
The aim of the intervention is to analyse the effect of a probiotic supplement in a dose-responsive set up on functional intestinal symptoms among subjects diagnosed with IBS according to Rome III criteria. Subjective assessment of bowel symptoms, quality of life, anxiety and depression and adequate relief will be assessed as with questionnaires as outcome measures. The intestinal microbiota will be analysed from faecal samples.
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 |
|---|---|---|
| Active high | Active comparator | Dietary Supplement: Probiotic (Active high)Probiotic, high dose |
| Active low | Active comparator | Dietary Supplement: Probiotic (Active low)Probiotic, low dose |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
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 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.
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 (Active high)Also: LactobacillusHigher dose of probiotic supplement | Dietary supplement | Active high |
| Probiotic (Active low)Also: LactobacillusLower dose of probiotic supplement | Dietary supplement | Active low |
| PlaceboAlso: Maltodextrin as placeboPlacebo | Dietary supplement | Placebo |
Primary outcome
Change in functional bowel symptoms
Time frame: 0 weeks, 4 weeks, 12 weeks
Validated questionnaire
5 secondary outcomes
Change in quality of life
Time frame: 0 weeks, 4 weeks, 12 weeks
Change in anxiety and depression
Time frame: 0 weeks, 4 weeks and 12 weeks
Adequate relief
Time frame: Weekly over 3 month intervention
Change in faecal microbiota
Time frame: 0 weeks, 4 weeks, 12 weeks
Safety of investigational product
Time frame: Throughout the intervention phase
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 26 Jan 2016.
- Individual participant dataSharing planned: No
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A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
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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.
Lea Veijola, MD principal investigator
Herttoniemi Hospital
Arthur Ouwehand, PhD study chair
DuPont Nutrition and Health
Sampo Lahtinen, PhD study chair
DuPont Nutrition and Health
2 sites 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 (Active high) and Probiotic (Active low) in people with Irritable Bowel Syndrome, run by Danisco at 2 sites 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: finished, as of the sponsor's last update on 26 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Change in functional bowel symptoms (time frame: 0 weeks, 4 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 26 Jan 2016.