HealthyNCT00635388
A Study of the Effects of Probiotics in Children Grades 1-3
A study testing Lactobacillus (Probiotic 1) and Lactobacillus and Bifidobacterium (Probiotic 2) in people with Healthy, run by Procter and Gamble at 1 site in United States.
Trial summary
The primary objective of this study is to determine the appropriate study design for a full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in elementary school children relative to a placebo control. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lactobacillus (Probiotic 1) and Lactobacillus and Bifidobacterium (Probiotic 2)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to May 2008
- 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 5 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Be in good general health as reported by their parent(s)/legal guardian;
- Be willing to refrain from ingesting any product that contains fermented live bacteria (other than their test product) during the study as confirmed by their parent(s)/legal guardian(s);
- Be willing to continue their current dietary habits for the duration of the study as confirmed by their parent(s)/legal guardian(s)
Who cannot join
- Have a known hypersensitivity or allergy to any product ingredient to be ingested during the study, as reported by their parent(s)/legal guardian(s)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3
The primary objective of this study is to determine the appropriate study design for a full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in elementary school children relative to a placebo control.
- Conditions
- Healthy
- Being tested
- Placebo, Lactobacillus (Probiotic 1), Lactobacillus and Bifidobacterium (Probiotic 2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
oral, placebo, once/day for 12 weeks
Lactobacillus (Probiotic 1)Other
oral, Lactobacillus, once/day for 12 weeks
Lactobacillus and Bifidobacterium (Probiotic 2)Other
oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Sham comparator | Not described Receives: Other: Placebo |
| 2 | Experimental | Not described Receives: Other: Lactobacillus (Probiotic 1) |
| 3 | Experimental | Not described Receives: Other: Lactobacillus and Bifidobacterium (Probiotic 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of healthy days.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2008
- Study completionMay 2008
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Procter and Gamble
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carl J Eastwood, MS, Principal investigator, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635388
- Sponsor's protocol ID
- 2007149
- Status last verified
- Oct 2009
- First submitted
- 19 Feb 2008
- Last updated
- 16 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study of the Effects of Probiotics in Children Grades 1-3
- ClinicalTrials.gov ID
- NCT00635388
- Acronym / sponsor ID
- 2007149
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Procter and GambleIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 13 Mar 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.
The primary objective of this study is to determine the appropriate study design for a full-scale claims support study to evaluate the impact of 2 probiotics on healthy days in elementary school children relative to a placebo control.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Sham comparator | Other: Placebo |
| 2 | Experimental | Other: Lactobacillus (Probiotic 1) |
| 3 | Experimental | Other: Lactobacillus and Bifidobacterium (Probiotic 2) |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Be in good general health as reported by their parent(s)/legal guardian;
- Be willing to refrain from ingesting any product that contains fermented live bacteria (other than their test product) during the study as confirmed by their parent(s)/legal guardian(s);
- Be willing to continue their current dietary habits for the duration of the study as confirmed by their parent(s)/legal guardian(s)
Key exclusion criteria (1 listed)
- Have a known hypersensitivity or allergy to any product ingredient to be ingested during the study, as reported by their parent(s)/legal guardian(s)
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 |
|---|---|---|
| Placebooral, placebo, once/day for 12 weeks | Other | 1 |
| Lactobacillus (Probiotic 1)oral, Lactobacillus, once/day for 12 weeks | Other | 2 |
| Lactobacillus and Bifidobacterium (Probiotic 2)oral, Lactobacillus and Bifidobacterium, once/day for 12 weeks | Other | 3 |
Primary outcome
Number of healthy days.
Time frame: 12 weeks
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 16 Oct 2009.
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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.
Carl J Eastwood, MS principal investigator
Procter and Gamble
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 (Probiotic 1) and Lactobacillus and Bifidobacterium (Probiotic 2) in people with Healthy, run by Procter and Gamble at 1 site in United States.
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 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 16 Oct 2009. 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 United States. 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 healthy days. (time frame: 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 16 Oct 2009.