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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01717534
Other study ID # 10.42.NRC
Secondary ID
Status Completed
Phase N/A
First received October 24, 2012
Last updated August 26, 2013
Start date October 2012
Est. completion date July 2013

Study information

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

Clinical 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.


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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care


Intervention

Dietary Supplement:
heat-treated lactobacilli or placebo
Daily supplement of sachet with 1 g of powder over a 5 months period.

Locations

Country Name City State
Mexico Centro de Estudios Clinicos de Queretaro S.c. Querétaro Qro
Mexico Clinical Research Institute Tlalnepantla Edo. De Méx

Sponsors (1)

Lead Sponsor Collaborator
Nestlé

Country where clinical trial is conducted

Mexico, 

Outcome

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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