Diarrhea Clinical Trial
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
Verified date | August 2013 |
Source | Nestlé |
Contact | n/a |
Is FDA regulated | No |
Health authority | Mexico: Federal Commission for Sanitary Risks Protection |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 374 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Months to 48 Months |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Mexico | Centro de Estudios Clinicos de Queretaro S.c. | Querétaro | Qro |
Mexico | Clinical Research Institute | Tlalnepantla | Edo. De Méx |
Lead Sponsor | Collaborator |
---|---|
Nestlé |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Days with diarrhea | during 5 months of study period | No | |
Secondary | Number of episodes of upper respiratory infections | during 5 months | No | |
Secondary | Duration of upper respiratory infections | during 5 months | No | |
Secondary | Severity of upper respiratory infections | during 5 months | No | |
Secondary | Severity of gastrointestinal infections | during 5 months | No |
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