Gastrointestinal SymptomsPhase 2/3NCT01171014
Effect of Bifidobacterium Lactis HN019 on Colonic Transit Time and Digestive Symptoms
A Phase 2/3 study testing Bifidobacterium lactis HN019 in people with Gastrointestinal Symptoms, run by Fonterra Research Centre.
Trial summary
The purpose of this study was to investigate the dose response effect of Bifidobacterium lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Symptoms
- What is being tested?
- Bifidobacterium lactis HN019
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Dec 2009
- Phase
- Phase 2/3
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy males and females aged 25 to 65 years
- stool type 2-4 on the Bristol Stool Chart
- 1 to 3 bowel movements per week
Who cannot join
- use of any probiotic product intended to improve gastrointestinal function within the 2 weeks preceding study entry
- major chronic and uncontrolled systemic medical conditions
- severe gastrointestinal conditions known to prolong CTT
- lactose intolerance
- chronic diarrhea
- gastric bypass surgery or lap band insertion for weight loss
- regular laxative use
- pregnant or breast-feeding women
About this study
Official title: A Three-Arm, Placebo Controlled, Double-Blind, Single Center Study to Evaluate the Impact of Probiotic Strain Bifidobacterium Lactis HN019 on Intestinal Well-Being, Colonic Transit Time and Digestive Discomfort
The purpose of this study was to investigate the dose response effect of Bifidobacterium lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.
- Conditions
- Gastrointestinal Symptoms
- Being tested
- Bifidobacterium lactis HN019, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium lactis HN019Dietary supplement
Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days
Bifidobacterium lactis HN019Dietary supplement
Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days
PlaceboDietary supplement
Placebo, once a day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| High dose probiotic | Experimental | Bifidobacterium lactis HN019, 10 billion cfu/day Receives: Dietary Supplement: Bifidobacterium lactis HN019 |
| Low dose probiotic | Experimental | Bifidobacterium lactis HN019, 1 billion cfu/day Receives: Dietary Supplement: Bifidobacterium lactis HN019 |
| 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.
Colonic transit time
Measured: 14 days
Secondary outcomes (1)
Gastrointestinal symptoms
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal SymptomsStudies 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fonterra Research Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Danisco, Sprim Advanced Life Sciences
- Investigators
- Philip Waller, MD, Principal investigator, Accurate Clinical Research, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171014
- Sponsor's protocol ID
- #08-SPUS-o6-FON-01
- Status last verified
- Jul 2010
- First submitted
- 26 Jul 2010
- Last updated
- 28 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Arm, Placebo Controlled, Double-Blind, Single Center Study to Evaluate the Impact of Probiotic Strain Bifidobacterium Lactis HN019 on Intestinal Well-Being, Colonic Transit Time and Digestive Discomfort
- ClinicalTrials.gov ID
- NCT01171014
- Acronym / sponsor ID
- #08-SPUS-o6-FON-01
- Conditions
- Gastrointestinal Symptoms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fonterra Research CentreIndustry (pharma, biotech, devices)
- Collaborators
- Danisco, Sprim Advanced Life Sciences
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Jul 2010 (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 was to investigate the dose response effect of Bifidobacterium lactis HN019 supplementation on colonic transit time and gastrointestinal symptoms.
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 |
|---|---|---|
| High dose probiotic | Experimental | Dietary Supplement: Bifidobacterium lactis HN019Bifidobacterium lactis HN019, 10 billion cfu/day |
| Low dose probiotic | Experimental | Dietary Supplement: Bifidobacterium lactis HN019Bifidobacterium lactis HN019, 1 billion cfu/day |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- healthy males and females aged 25 to 65 years
- stool type 2-4 on the Bristol Stool Chart
- 1 to 3 bowel movements per week
Key exclusion criteria (8 listed)
- use of any probiotic product intended to improve gastrointestinal function within the 2 weeks preceding study entry
- major chronic and uncontrolled systemic medical conditions
- severe gastrointestinal conditions known to prolong CTT
- lactose intolerance
- chronic diarrhea
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 |
|---|---|---|
| Bifidobacterium lactis HN019Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days | Dietary supplement | High dose probiotic |
| Bifidobacterium lactis HN019Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days | Dietary supplement | Low dose probiotic |
| PlaceboPlacebo, once a day for 14 days | Dietary supplement | Placebo |
Primary outcome
Colonic transit time
Time frame: 14 days
1 secondary outcome
Gastrointestinal symptoms
Time frame: 14 days
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 28 Jul 2010.
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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.
Philip Waller, MD principal investigator
Accurate Clinical Research, Houston, TX
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bifidobacterium lactis HN019 in people with Gastrointestinal Symptoms, run by Fonterra Research Centre.
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 3 inclusion and 8 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 28 Jul 2010. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Colonic transit time (time frame: 14 days). 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 28 Jul 2010.