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The purpose of this study is to determine which of two different preparations of probiotics is effective in the treatment of acute viral diarrhoea in children.
Children and infants, aged 1 month to 5 years, with acute diarrhoea, will be randomised to receive either saccharomyces boulardii, a combination probiotic (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium infantis, Streptococcus thermophillus) or placebo, to determine if one shortens the duration of diarrhoea.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saccharomyces boulardii | Experimental | FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days. |
|
| Probiotics combination | Experimental | LACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu |
|
| Placebo | Placebo Comparator | Placebo sachet. One sachet orally, BID, for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saccharomyces boulardii | Dietary Supplement | FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of diarrhoea in hours | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of children requiring hospitalisation | Up to 7 days | |
| Adverse effects | Up to 7 days | |
| Number of liquid stools |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giordano PĂ©rez-Gaxiola, MD | Sinaloa Pediatric Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sinaloa Pediatric Hospital | Culiacán | Sinaloa | 80200 | Mexico |
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| Probiotics combination | Dietary Supplement | LACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu |
|
| Placebo | Other | Placebo |
|
| Up to seven days |
| D013568 | Pathological Conditions, Signs and Symptoms |