DiarrheaNCT01717534
Children Immune Functions
A study of Diarrhea and Upper Respiratory Infections, run by Société des Produits Nestlé (SPN) at 2 sites in Mexico.
Trial summary
The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind, placebo-controlled study. Read more about this study
- Who is it for?
- Ages 12 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Upper Respiratory Infections
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 374 participants
- Where
- 2 sitesMexico
- Study dates
- Oct 2012to Jul 2013
- 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 12 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents written and signed informed consent for participation in the study: parents agree with the participation in the study, dated and signed informed consent form prior to any study related procedure.
- Healthy children aged 1 to 4 years
- No more breastfed.
- Daily home cared and going to a selected pediatrician.
- Parents must have a phone at home or a cellular phone to call the paediatrician.
- No consumption of commercial products containing probiotics and / or prebiotics during the 3 weeks before and during the study period.
- Children not being intensive consumers of regular yoghurts
- Parents are able to keep a daily record of symptoms and to administrate the study products.
Who cannot join
- Vaccine administration within the last 3 months prior study start.
- Used antibiotics within the last month
- Congenital or chronic disease.
- Any kind of immunodeficiency or allergy.
- Acute infection or fever.
- Significant illness within the two weeks prior to the start of the study.
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Centro de Estudios Clinicos de Queretaro S.c.
Querétaro City, Querétaro, 76000
Clinical Research Institute
Tlalnepantla, Edo. de Méx, 54055
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Heat-treated Lactobacilli on Infections and Immune Status in Healthy Children
The purpose of the planned study is to investigate the effect of heat-treated lactobacilli on diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind, placebo-controlled study.
Read the detailed description
The beneficial effect of heat-treated lactobacilli for treatment of symptomatic diarrhea was clearly documented and the purpose of this planned study is to investigate the effect on reduction of days with diarrhea in a preventive setting in healthy children 1-4 years old. Moreover, the study is intended to evaluate the impact on the immune status of the children.
- Conditions
- Diarrhea, Upper Respiratory Infections
- Being tested
- heat-treated lactobacilli or placebo
- Keywords
- Diarrhea, Children, Heat-treated lactobacilli
- Medical subject headings
- Diarrhea, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heat-treated lactobacilli or placeboDietary supplement
Daily supplement of sachet with 1 g of powder over a 5 months period.
| Study group | Role | What they receive |
|---|---|---|
| Heat-treated lactobacilli | Experimental | One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water.
The duration of the treatment is 5 months. Receives: Dietary Supplement: heat-treated lactobacilli or placebo |
| Maltodextrin | Placebo comparator | One sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water.
The duration of the treatment is 5 months. Receives: Dietary Supplement: heat-treated lactobacilli or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days with diarrhea
Measured: during 5 months of study period
Secondary outcomes (4)
Number of episodes of upper respiratory infections
Measured: during 5 months
Duration of upper respiratory infections
Measured: during 5 months
Severity of upper respiratory infections
Measured: during 5 months
Severity of gastrointestinal infections
Measured: during 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Angeles Nava Hernández, MD, Principal investigator, Center of Clinical Research of QuerétaroCarlos A. Mena Cedillos, MD, Principal investigator, Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717534
- Sponsor's protocol ID
- 10.42.NRC
- Status last verified
- Aug 2013
- First submitted
- 24 Oct 2012
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study to Investigate the Effect of Heat-treated Lactobacilli on Infections and Immune Status in Healthy Children
- ClinicalTrials.gov ID
- NCT01717534
- Acronym / sponsor ID
- 10.42.NRC
- Conditions
- Diarrhea, Upper Respiratory Infections
- Keywords
- Diarrhea, Children, Heat-treated lactobacilli
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Oct 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 the planned study is to investigate the effect of heat-treated lactobacilli on diarrhea outcome in healthy children 1-4 years old in a randomized, double-blind, placebo-controlled study.
Detailed description
The beneficial effect of heat-treated lactobacilli for treatment of symptomatic diarrhea was clearly documented and the purpose of this planned study is to investigate the effect on reduction of days with diarrhea in a preventive setting in healthy children 1-4 years old. Moreover, the study is intended to evaluate the impact on the immune status of the children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat-treated lactobacilli | Experimental | Dietary Supplement: heat-treated lactobacilli or placeboOne sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water. The duration of the treatment is 5 months. |
| Maltodextrin | Placebo comparator | Dietary Supplement: heat-treated lactobacilli or placeboOne sachets (1 gram of content) will be consumed once a day, and will be suspended in a provided milk powder to be reconstituted with water. The duration of the treatment is 5 months. |
Who may qualify
- Ages
- 12 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Parents written and signed informed consent for participation in the study: parents agree with the participation in the study, dated and signed informed consent form prior to any study related procedure.
- Healthy children aged 1 to 4 years
- No more breastfed.
- Daily home cared and going to a selected pediatrician.
- Parents must have a phone at home or a cellular phone to call the paediatrician.
Key exclusion criteria (6 listed)
- Vaccine administration within the last 3 months prior study start.
- Used antibiotics within the last month
- Congenital or chronic disease.
- Any kind of immunodeficiency or allergy.
- Acute infection or fever.
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 |
|---|---|---|
| heat-treated lactobacilli or placeboDaily supplement of sachet with 1 g of powder over a 5 months period. | Dietary supplement | Heat-treated lactobacilli, Maltodextrin |
Primary outcome
Days with diarrhea
Time frame: during 5 months of study period
4 secondary outcomes
Number of episodes of upper respiratory infections
Time frame: during 5 months
Duration of upper respiratory infections
Time frame: during 5 months
Severity of upper respiratory infections
Time frame: during 5 months
Severity of gastrointestinal infections
Time frame: during 5 months
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 27 Aug 2013.
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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.
Angeles Nava Hernández, MD principal investigator
Center of Clinical Research of Querétaro
Carlos A. Mena Cedillos, MD principal investigator
Clinical Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diarrhea and Upper Respiratory Infections, run by Société des Produits Nestlé (SPN) at 2 sites in Mexico.
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 8 inclusion and 6 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 27 Aug 2013. 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 Mexico. 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?
Days with diarrhea (time frame: during 5 months of study period). 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 27 Aug 2013.