Acute Bloody Diarrhea of 7 Days or Less Duration
Conditions
Keywords
ACUTE BLOODY DIARRHEA. SACCHAROMYCES BOULARDII
Brief summary
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.
Detailed description
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.
Interventions
DRUGSaccharomyces boulardi (Sb)
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
DRUGPlacebo
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
Sponsors
Fundación Hospital de Pediatría Prof. Dr. Juan P. Garrahan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Months to 71 Months
Healthy volunteers
No
Inclusion criteria
* all children between 0.25 and 5.99 years * attending emergency clinic because of acute diarrhea, * showing stools with presence of blood, * whose parents were adequately informed, and signed the corresponding consent
Exclusion criteria
* diarrhea lasting more than 7 days at inclusion * presence of malnutrition and any other chronic or major disease, * previous or concomitant intake of steroids, or other immunosuppressive drugs, * immunocompromised
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of total stools per day | From baseline to end of follow-up (Day 14) | Number of stools in children with or without blood in stools |
| Number of bloody stools per day | From baseline to end of follow-up (Day 14) | Number of stools in children with blood in stools |
| Duration of bloody diarrhea | From baseline to end of follow-up (Day 14) | The number of days of bloody diarrhea between SB and placebo groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with positive stool culture, ELISA, PCR | At baseline | 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 |
| Safety adverse events | From baseline to end of follow-up (Day 14) | Differences in adverse events between both groups |
Countries
Argentina
Contacts
STUDY_DIRECTORMaria Gracia Caletti, Dr
PRINCIPAL_INVESTIGATORDiana Kelmansky, Dr
Statistician
Outcome results
None listed