NCT02405923

Brief Summary

This is a multicenter, controlled, randomized, prospective, non-inferiority, double blind intervention trial to evaluate the children growth (at 6, 9 and 12 months) using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of Cow's Milk Protein Allergy (CMPA).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
2 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2019

Completed
Last Updated

July 18, 2019

Status Verified

July 1, 2019

Enrollment Period

4.8 years

First QC Date

November 13, 2014

Last Update Submit

July 15, 2019

Conditions

Cow's Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • Growing change

    To evaluate the children growth using a rice hydrolysed protein formula compared to an extensively cow's milk protein hydrolysed formula for the management of CMPA.

    6 months

Secondary Outcomes (3)

  • Nutritional adequacy

    6 months

  • Contaminants

    6 months

  • Tolerance acquisition to cow's milk protein measured by a cow milk OFC (Open Food Challenge)

    6 months

Study Arms (2)

HRF (Rice formula)

EXPERIMENTAL

Hydrolyzed Rice Protein Formula (HRF)

Other: HRF

eHF (Extensive Hydrolysed Formula)

PLACEBO COMPARATOR

Extensive Hydrolysed Cow's Milk Protein Formula (eHF)

Other: eHF

Interventions

HRFOTHER

The subject will take the formula for a period of 12 months.

Also known as: HRF-1 from 0 to 6 months of age, HRF-2 from 6 months of age onwards
HRF (Rice formula)
eHFOTHER

The subject will take the formula for a period of 12 months.

Also known as: eHF-1 from 0 to 6 months of age, eHF-2 from 6 months of age onwards
eHF (Extensive Hydrolysed Formula)

Eligibility Criteria

AgeUp to 10 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Subjects up to 10 months old with clinical history of a reaction to cow's milk protein and/or confirmed diagnosis (up to grade II anaphylaxis) of allergy to cow's milk protein by one of the following criteria, within two months prior to the baseline visit are eligible to enter the study:
  • Negative or positive skin prick tests ( fresh milk, rice, casein hydrolysates)
  • Negative or positive specific IgE for cow's milk proteins (alphalactalbumine, betalactoglobuline, caseine and cow's milk)
  • Negative or positive Milk Atopy Patch Test
  • Positive Double Blind Placebo Control Food Challenge (DBPCFC) with cow milk
  • Gestational Age 37-42 weeks inclusive
  • Apgar SCORE \>7 at 5 minutes
  • Singleton birth
  • Birth weight ≥2.500 g
  • Written informed consent

You may not qualify if:

  • Previous signs of allergy to any extensively hydrolysed formula
  • Confirmed history of acute severe, potentially life threatening reaction after isolated accidental ingestion of cow's milk e.g. history of anaphylactic reaction, graded more or equal to grade III, as this could not be compatible with an allocation to the eHF group
  • Daily formula intake \< 100 ml
  • Major congenital malformations or neonatal diseases
  • Severe concurrent or chronic diseases
  • Intrauterine growth retardation
  • Neonatal infections ( e.g. CMV, HIV)
  • Simultaneous participation in other clinical trials
  • Parents not signing written informed consent
  • Unable to adhere to protocol requirements or study visits due to non compliance of parents or caregivers.
  • Liver, kidney, haematological abnormalities as judged clinically by investigators at baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hôpital Necker-Enfants Malades

Paris, Cedex 14, 75674, France

Location

Hôpital Saint Vincent-de-Paul

Lille, Lille Cedex, 59020, France

Location

Hospital Infantil Virgen del Rocío

Seville, Andalusia, 41013, Spain

Location

Hospital Materno Infantil de Málaga

Málaga, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Aging

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • Mireia Mireia, MD

    Laboratorios Ordesa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2014

First Posted

April 1, 2015

Study Start

July 1, 2014

Primary Completion

April 11, 2019

Study Completion

April 11, 2019

Last Updated

July 18, 2019

Record last verified: 2019-07

Locations

FR(2)ES(3)