HealthyNCT00987311
Effect of Probiotic Fermented Dairy Drinks on Intestinal Immune Response
A study testing 1- Dairy drink containing probiotics A and 2- Dairy drink containing probiotics B in people with Healthy, run by Danone Global Research & Innovation Center.
Trial summary
The purpose of this study is to investigate whether two different fermented dairy drinks consumed daily could have an effect on the intestinal immune response in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 1- Dairy drink containing probiotics A and 2- Dairy drink containing probiotics B
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Dec 2011
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male/female subjects aged from 18 to 45 years (bounds included).
- Subjects with none of the symptoms of gastrointestinal infectious diseases
- Subjects with a body mass index (BMI) between 19 and 30 kg/m² (bounds included).
- Subjects who accept to be submitted to an alimentary restriction of product with OTC and foods containing probiotics and/or prebiotics
- Subjects who regularly consume and appreciate dairy products
- Subjects who have not consumed any products or OTCs containing probiotics within the last three months.
Who cannot join
- Subjects in a situation that, in the investigator opinion, could interfere with optimal participation in the present study (e.g. non dairy-products consumer) or could constitute a special risk for the subject.
- Subjects with allergies or hypersensitivity to any component of the study product (e.g: allergy or hypersensitivity to milk proteins, or lactose intolerance)
- Subjects with any food allergy
- Subjects with auto-immune or with chronic disease or with a history of chronic metabolic or gastrointestinal.
- Subjects who have had any surgery or intervention requiring general anaesthesia in the last 4 weeks..
- Subjects with special diet requirements
- For female subjects: pregnancy, breast feeding or no method of contraceptive used
- Subjects participating in any other interventional study concomitantly or within 4 weeks of the study entry date.
About this study
Official title: Pilot Study on the Effects of Probiotic Fermented Dairy Drinks on the Intestinal Immune Response in Healthy Adults
The purpose of this study is to investigate whether two different fermented dairy drinks consumed daily could have an effect on the intestinal immune response in healthy subjects.
- Conditions
- Healthy
- Being tested
- 1- Dairy drink containing probiotics A, 2- Dairy drink containing probiotics B, 3- Dairy drink without probiotics (control)
- Keywords
- Probiotics, intestinal immune system, human, healthy subjects, dairy drink, Healthy adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1- Dairy drink containing probiotics ADietary supplement
1- Dairy drink containing probiotics A
2- Dairy drink containing probiotics BDietary supplement
2- Dairy drink containing probiotics B
3- Dairy drink without probiotics (control)Dietary supplement
3- Dairy drink without probiotics (control)
| Study group | Role | What they receive |
|---|---|---|
| 1-Test product A | Active comparator | 1-Dairy product containing probiotics A (test product A) Receives: Dietary Supplement: 1- Dairy drink containing probiotics A |
| 2-Test product B | Active comparator | 2-Dairy product containing probiotics B (test product B) Receives: Dietary Supplement: 2- Dairy drink containing probiotics B |
| 3-Control | Sham comparator | 3-Dairy product without probiotics (control) Receives: Dietary Supplement: 3- Dairy drink without probiotics (control) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2009
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Global Research & Innovation Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987311
- Sponsor's protocol ID
- NU311
- Status last verified
- Jan 2017
- First submitted
- 28 Sep 2009
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effects of Probiotic Fermented Dairy Drinks on the Intestinal Immune Response in Healthy Adults
- ClinicalTrials.gov ID
- NCT00987311
- Acronym / sponsor ID
- NU311
- Conditions
- Healthy
- Keywords
- Probiotics, intestinal immune system, human, healthy subjects, dairy drink, Healthy adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Danone Global Research & Innovation CenterIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 30 Sep 2009 (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 investigate whether two different fermented dairy drinks consumed daily could have an effect on the intestinal immune response in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1-Test product A | Active comparator | Dietary Supplement: 1- Dairy drink containing probiotics A1-Dairy product containing probiotics A (test product A) |
| 2-Test product B | Active comparator | Dietary Supplement: 2- Dairy drink containing probiotics B2-Dairy product containing probiotics B (test product B) |
| 3-Control | Sham comparator | Dietary Supplement: 3- Dairy drink without probiotics (control)3-Dairy product without probiotics (control) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male/female subjects aged from 18 to 45 years (bounds included).
- Subjects with none of the symptoms of gastrointestinal infectious diseases
- Subjects with a body mass index (BMI) between 19 and 30 kg/m² (bounds included).
- Subjects who accept to be submitted to an alimentary restriction of product with OTC and foods containing probiotics and/or prebiotics
- Subjects who regularly consume and appreciate dairy products
Key exclusion criteria (8 listed)
- Subjects in a situation that, in the investigator opinion, could interfere with optimal participation in the present study (e.g. non dairy-products consumer) or could constitute a special risk for the subject.
- Subjects with allergies or hypersensitivity to any component of the study product (e.g: allergy or hypersensitivity to milk proteins, or lactose intolerance)
- Subjects with any food allergy
- Subjects with auto-immune or with chronic disease or with a history of chronic metabolic or gastrointestinal.
- Subjects who have had any surgery or intervention requiring general anaesthesia in the last 4 weeks..
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 |
|---|---|---|
| 1- Dairy drink containing probiotics A1- Dairy drink containing probiotics A | Dietary supplement | 1-Test product A |
| 2- Dairy drink containing probiotics B2- Dairy drink containing probiotics B | Dietary supplement | 2-Test product B |
| 3- Dairy drink without probiotics (control)3- Dairy drink without probiotics (control) | Dietary supplement | 3-Control |
Primary outcome
Not reported in the source record.
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 20 Jan 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 1- Dairy drink containing probiotics A and 2- Dairy drink containing probiotics B in people with Healthy, run by Danone Global Research & Innovation Center.
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 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 20 Jan 2017. 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.
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.
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 20 Jan 2017.