Tolerance of Infants With Cow's Milk Protein Allergy to Extensively Hydrolyzed Rice Protein or Casein Infant Formulas

NCT01909661 | Completed Phase 2 DMC

• 1 other identifier: LRD - 2013 - JUNGLO
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this double blinded randomized study is to assess the tolerance of two extensively protein hydrolyzed infant formulas, one based on rice protein and the other one on casein, at introduction, and after 3 months of consumption, and their efficacy on growth and on the reduction of allergy symptoms through a 3 months consumption period.

Conditions

Cow Milk Protein Sensitivity; Tolerance; Growth Failure

Keywords

allergy; Cow's milk protein; Tolerance; Efficacy; Infants' growth

Outcome Measures

Primary Outcomes (1)

• Proportion of infants who tolerate either the rice hydrolyzed protein infant formula or a hydrolyzed casein infant formula after 24h consumption.

  Tolerance is absence of clinical signs.

  24h

Secondary Outcomes (1)

• Effectivness of the hydrolyzed protein formulas in terms of growth and allergy symptoms improvement.

  3 months

Other Outcomes (1)

• Volume of infant formula consumed by the infants

  3 months

Study Arms (2)

Damira/Celia peptide hydrolyzed casein

EXPERIMENTAL

Extensively Hydrolyzed (EH)casein infant formula

Other: Damira/Celia peptide hydrolyzed casein

Picot riz/Celia rice/Sanutri arroz

EXPERIMENTAL

Picot riz/Celia rice/Sanutri arroz Extensively Hydrolyzed (EH) rice protein infant formula

Other: Picot riz/Celia rice/Sanutri arroz

Interventions

Damira/Celia peptide hydrolyzed casein OTHER

Damira/Celia peptide hydrolyzed casein

Picot riz/Celia rice/Sanutri arroz OTHER

Picot riz/Celia rice/Sanutri arroz

Eligibility Criteria

• Age: Up to 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Full term healthy newborns (37-42 Weeks gestation)
• Weight at birth ≥ 2500 g
• Aged between birth to 9 months
• Symptoms of allergy (Skin or digetive)
• Suspicion of cow milk protein allergy
• Infants whose parents/caregivers/legal guardians have the ability to understand and comply with the requirements of the study
• Infants whose parents/caregivers/legal guardians gave their written informed consent to the infant's participation in the study

You may not qualify if:

• Children who have returned to breastfeeding
• Presence of any condition, that, in the opinion of the investigator is a contra-indication to the particpation of the infant in the study
• In the past 15 days, treatment or medication likely to :
• induce confusion in the allergy tets (ex. : Skin Prick Test) and / or
• mask the symptoms of an allergic reaction (Anti-allergy medications ; anti-histaminic, anti-leucotrienes, corticosteroids, …)
• Newbonrs presenting a chronic or a genetic malformation, or a chromosomal or other disease, that in the opinion of the investigator could mask the study results
• Children who show signs of malnutrition, or prolonged diarrhea
• Children whose parents show no willingness to comply with study requirements

Sponsors & Collaborators

• Lactalis: lead
• Biosearch S.A.: collaborator

Study Sites (1)

Biosearch S.A.

Granada, 18004, Spain

Location

MeSH Terms

Conditions

Failure to Thrive; Hypersensitivity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 26, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 17, 2015

Record last verified: 2013-07

Locations

ES (1)