COMPARISON OF ORAL REHYDRATION SOLUTIONS OF GLUCOSE, RICE AND RICE LACTOFERRINA / LISOZYMA FOR THE MANAGEMENT OF DIARRHEA IN PERUVIAN CHILDREN.
- Conditions
- -K318 Other specified diseases of stomach and duodenumOther specified diseases of stomach and duodenumK318
- Registration Number
- PER-016-03
- Lead Sponsor
- Ventria Bioscience,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Boys, 4 to 36 months of age
• Acute acute watery diarrhea in the last 72 hours
• Mild or moderate dehydration
• Can tolerate liquids
• No episodes of diarrhea during the 2 weeks prior to the beginning of the episode current diarrhea
• You have not taken antibiotics during the current episode of diarrhea.
• The child wears or tolerates diapers and urine collection bags.
• Parents agree that their children use urine collection bags in addition to diapers
• Parents willing to give written consent and allow home visits
• Presence of any chronic disease or systemic infection
• Severe malnutrition (W / H - <2 ZS; Kwashiorkor / marasmus)
• Blood visible in the stools.
• Known allergy to rice or rice products.
• Exclusive breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:volume and characteristics of bowel movements, through the use and weighing of disposable diapers; of diuresis through the use of urine collection bags, of the volume consumed of ORS, of any vomit that could present.<br>Measure:Compare the glucose-based oral rehydration solution with a rice-based ORS and a rice-based ORS containing recombinant human lactoferrin (rhLF) and recombinant human lysozyme (rhLY) in concentrations similar to those found in milk maternal<br>Timepoints:14 days<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:not contemplated<br>Measure:not contemplated<br>Timepoints:not contemplated<br>