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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| heat-treated lactobacilli or placebo | Dietary Supplement | Daily supplement of sachet with 1 g of powder over a 5 months period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days with diarrhea | during 5 months of study period |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angeles Nava Hernández, MD | Center of Clinical Research of Querétaro | Principal Investigator |
| Carlos A. Mena Cedillos, MD | Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Institute | Tlalnepantla | Edo. de Méx | 54055 | Mexico | ||
| Centro de Estudios Clinicos de Queretaro S.c. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| during 5 months |
| Severity of gastrointestinal infections | during 5 months |
| Querétaro City |
| Querétaro |
| 76000 |
| Mexico |
| D012140 | Respiratory Tract Diseases |