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Acute diarrhea (AD) is one of the commonest illnesses in children. A particularly severe form of diarrhea is bloody diarrhea (BD).
Saccharomyces boulardii CNCM I-745 is a probiotic with demonstrated efficacy in children with acute diarrhea; however, evidence regarding its use in bloody diarrhea (BD) is lacking. This project aims to assess the efficacy and safety of Saccharomyces boulardii CNCM I-745 on bloody diarrhea in children.
The study objective are :
• To assess the efficacy of Sacharomyces Boulardi (SB) on acute bloody diarrhea in children aged 0 - 5 years. Indicators: duration of bloody diarrhea, daily frequency of stools with blood, daily frequency of total stools with or without blood during follow up.
• To assess the most frequent bacterial agents
• To assess the safety of the product. The study is a double blind, controlled trial (SB or placebo), with two arms parallel, randomized design, carried out on outpatient clinic because of acute bloody diarrhea.
Patients with acute bloody diarrhea were prescribed randomly and blindly placebo or Saccharomyces boulardii 500 mg /day seven days (250 mg for children between 0.25 - 1.00 years),and were seen in outpatient clinics of three hospitals at days 1, 3, and 7. On day 14 they were contacted by telephone call. Parents registered daily number of stools, with or without diarrhea, and any new symptom appearing during follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saccharomyces boulardi (Sb) | Drug | Drug: Saccharomyces Boulardii 250 MG Saccharomyces boulardi (Sb) 250 mg dose to be administered to the patient : - twice a day, to children from older than 1.0 year, up to 5.99 years, - or once a day to children 1year old or younger |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of bloody diarrhea | The number of days of bloody diarrhea between SB and placebo groups | From baseline to end of follow-up (Day 14) |
| Number of total stools per day | Number of stools in children with or without blood in stools | From baseline to end of follow-up (Day 14) |
| Number of bloody stools per day | Number of stools in children with blood in stools | From baseline to end of follow-up (Day 14) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with positive stool culture, ELISA, PCR | Stool culture for O157:H7 or non-O157:H7 enterohemorrhagic E. coli, PCR and/or ELISA for verotoxins and detection of Campylobacter spp, Shigella spp, Salmonella spp and other pathogens | At baseline |
| Safety adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Gracia Caletti, Dr | Study Director | |
| Diana Kelmansky, Dr | Statistician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Tetamanti in Mar del Plata (HIEMI) | Mar del Plata | Buenos Aires | 7600 | Argentina | ||
| Hospital Ramos MejÃa, Servicio de PediatrÃa (SPHRM) |
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| Placebo | Drug | Drug: Placebo Placebo to be administered to the patient : -twice a day, to children from older than 1.0 year, up to 5.99 years, - or once a day to children 1year old or younger |
|
Differences in adverse events between both groups |
| From baseline to end of follow-up (Day 14) |
| Buenos Aires |
| Buenos Aires F.D. |
| 1704 |
| Argentina |
| Hospital Materno Infantil de Salta | Salta | Salta Province | 4400 | Argentina |