Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)NCT00796393
Study of the Effects of Probiotics Upon Infectious Episodes in Subject Aged More Than 60, During Winter.
A study testing Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033 and Starch of potato in people with Infectious Episodes (ENT, Gastro-intestinal and Pulmonary), run by Institut Rosell Lallemand at 1 site in France.
Trial summary
We put forward that probiotics have an effect on infectious episodes evolution in subjects aged 60 years or over. The main objective of this research is to observe the effect of consumption of the probiotic on the average number of days with infectious episodes. Read more about this study
- Who is it for?
- Ages 60 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)
- What is being tested?
- Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033 and Starch of potato
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Apr 2010
- 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 60 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who accept not to alter their food habits
Who cannot join
- Food allergy
- Regular consumption of probiotics
- Diabetes
- Respiratory deficiency
- Cardiac deficiency
- Cancer or chronicle disease not stabilized
Show all 9Show fewer
- Splenectomy, sickle-cell anemia
- Immuno depression or immunodeficiency acquired or congenital
- Immuno depressor or corticoid treatments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Daily Consumption of a Probiotic on the Evolution of Infectious Episodes (ENT, Gastro-intestinal and Pulmonary), in Subject Aged 60 Years or Over, During Winter.
We put forward that probiotics have an effect on infectious episodes evolution in subjects aged 60 years or over. The main objective of this research is to observe the effect of consumption of the probiotic on the average number of days with infectious episodes.
- Being tested
- Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033, Starch of potato
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033Dietary supplement
1 pill per day for 12 weeks
Starch of potatoDietary supplement
1 pill per day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Subject with active product, not vaccinated against influenza. Receives: Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033 |
| 3 | Placebo comparator | Subject with placebo, vaccinated against influenza. Receives: Dietary Supplement: Starch of potato |
| 4 | Placebo comparator | Subject with placebo, not vaccinated against influenza. Receives: Dietary Supplement: Starch of potato |
| 1 | Experimental | Subject with active product, vaccinated against influenza Receives: Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of infectious episodes
Measured: During the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious Episodes (ENT, Gastro-intestinal and Pulmonary)Studies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Rosell Lallemand
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Investigators
- Jean Marc Cazaubiel, Dr, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796393
- Sponsor's protocol ID
- 10308
- Other IDs
- 2008-A01187-48
- Status last verified
- Jun 2011
- First submitted
- 21 Nov 2008
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Consumption of a Probiotic on the Evolution of Infectious Episodes (ENT, Gastro-intestinal and Pulmonary), in Subject Aged 60 Years or Over, During Winter.
- ClinicalTrials.gov ID
- NCT00796393
- Acronym / sponsor ID
- 10308
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institut Rosell LallemandIndustry (pharma, biotech, devices)
- Collaborators
- BioFortis
- Study start
- Nov 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 24 Nov 2008 (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.
We put forward that probiotics have an effect on infectious episodes evolution in subjects aged 60 years or over. The main objective of this research is to observe the effect of consumption of the probiotic on the average number of days with infectious episodes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033Subject with active product, not vaccinated against influenza. |
| 3 | Placebo comparator | Dietary Supplement: Starch of potatoSubject with placebo, vaccinated against influenza. |
| 4 | Placebo comparator | Dietary Supplement: Starch of potatoSubject with placebo, not vaccinated against influenza. |
| 1 | Experimental | Dietary Supplement: Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033Subject with active product, vaccinated against influenza |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who accept not to alter their food habits
Key exclusion criteria (9 listed)
- Food allergy
- Regular consumption of probiotics
- Diabetes
- Respiratory deficiency
- Cardiac deficiency
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 |
|---|---|---|
| Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R00331 pill per day for 12 weeks | Dietary supplement | 1, 2 |
| Starch of potato1 pill per day for 12 weeks | Dietary supplement | 3, 4 |
Primary outcome
Number of infectious episodes
Time frame: During the study
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 23 Jun 2011.
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.
Jean Marc Cazaubiel, Dr principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus helveticus R0052, Bifidobacterium bifidum R0071, Bifidobacterium infantis R0033 and Starch of potato in people with Infectious Episodes (ENT, Gastro-intestinal and Pulmonary), run by Institut Rosell Lallemand at 1 site in France.
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 9 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 23 Jun 2011. 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 France. 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.
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?
Number of infectious episodes (time frame: During the study). 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 23 Jun 2011.