Children Immune Functions
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ClinicalTrials.gov Identifier: NCT01717534 |
Recruitment Status
:
Completed
First Posted
: October 30, 2012
Last Update Posted
: August 27, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diarrhea Upper Respiratory Infections | Dietary Supplement: heat-treated lactobacilli or placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 374 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
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 |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Heat-treated lactobacilli
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. |
Dietary Supplement: heat-treated lactobacilli or placebo
Daily supplement of sachet with 1 g of powder over a 5 months period.
|
Placebo Comparator: Maltodextrin
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. |
Dietary Supplement: heat-treated lactobacilli or placebo
Daily supplement of sachet with 1 g of powder over a 5 months period.
|
- Days with diarrhea [ Time Frame: during 5 months of study period ]
- 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 ]

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Ages Eligible for Study: | 12 Months to 48 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717534
Mexico | |
Clinical Research Institute | |
Tlalnepantla, Edo. De Méx, Mexico, 54055 | |
Centro de Estudios Clinicos de Queretaro S.c. | |
Querétaro, Qro, Mexico, 76000 |
Principal Investigator: | Angeles Nava Hernández, MD | Center of Clinical Research of Querétaro | |
Principal Investigator: | Carlos A. Mena Cedillos, MD | Clinical Research Institute |
Responsible Party: | Nestlé |
ClinicalTrials.gov Identifier: | NCT01717534 History of Changes |
Other Study ID Numbers: |
10.42.NRC |
First Posted: | October 30, 2012 Key Record Dates |
Last Update Posted: | August 27, 2013 |
Last Verified: | August 2013 |
Keywords provided by Nestlé:
Diarrhea Children Heat-treated lactobacilli |
Additional relevant MeSH terms:
Infection Diarrhea Respiratory Tract Infections |
Signs and Symptoms, Digestive Signs and Symptoms Respiratory Tract Diseases |