Diarrhea, Upper Respiratory Infections
Conditions
Keywords
Diarrhea, Children, Heat-treated lactobacilli
Brief 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.
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.
Interventions
DIETARY_SUPPLEMENTheat-treated lactobacilli or placebo
Daily supplement of sachet with 1 g of powder over a 5 months period.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 48 Months
Healthy volunteers
Yes
Inclusion criteria
1. 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. 2. Healthy children aged 1 to 4 years 3. No more breastfed. 4. Daily home cared and going to a selected pediatrician. 5. Parents must have a phone at home or a cellular phone to call the paediatrician. 6. No consumption of commercial products containing probiotics and / or prebiotics during the 3 weeks before and during the study period. 7. Children not being intensive consumers of regular yoghurts 8. Parents are able to keep a daily record of symptoms and to administrate the study products.
Exclusion criteria
1. Vaccine administration within the last 3 months prior study start. 2. Used antibiotics within the last month 3. Congenital or chronic disease. 4. Any kind of immunodeficiency or allergy. 5. Acute infection or fever. 6. Significant illness within the two weeks prior to the start of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days with diarrhea | during 5 months of study period |
Secondary
| Measure | Time frame |
|---|---|
| Number of episodes of upper respiratory infections | during 5 months |
| Duration of upper respiratory infections | during 5 months |
| Severity of upper respiratory infections | during 5 months |
| Severity of gastrointestinal infections | during 5 months |
Countries
Mexico
Outcome results
None listed