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COMPARISON OF ORAL REHYDRATION SOLUTIONS OF GLUCOSE, RICE AND RICE LACTOFERRINA / LISOZYMA FOR THE MANAGEMENT OF DIARRHEA IN PERUVIAN CHILDREN.

COMPARISON OF ORAL REHYDRATION SOLUTIONS OF GLUCOSE, RICE AND RICE LACTOFERRINA / LISOZYMA FOR THE MANAGEMENT OF DIARRHEA IN PERUVIAN CHILDREN.

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
REPEC
Registry ID
PER-016-03
Enrollment
Unknown
Registered
2003-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

recombinant human lysozyme Type of group
Rice-based ORS will be administered with 0.2 mg / mL of recombinant human lizosima. Group name:recombinant human lactoferrin Type of group
Rice-based ORS will be administered with 1 mg / mL recombinant human lactoferrin.

Sponsors

Ventria Bioscience,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

MeasureTime frame
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. 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 Timepoints:14 days

Secondary

MeasureTime frame
Outcome name:not contemplated Measure:not contemplated Timepoints:not contemplated

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)