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Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins

Primary Purpose

Cow Milk Allergy

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
rice formula
placebo
Sponsored by
United Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow Milk Allergy

Eligibility Criteria

1 Month - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • with suspected CMA or with a CMA diagnosed by a DBPCFC performed in the last 2 months prior to inclusion
  • free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet);
  • whose parents signed the informed consent

Exclusion Criteria:

  • mainly breast fed, drinking less than 250ml of formula/day, presenting any situation, which, according to the investigator, may interfere with the study participation or lead to a particular risk for the subject

Sites / Locations

  • CHR Namur
  • Hôpital Saint Vincent de Paul - GHICL
  • Hopital Trousseau
  • University of Naples Federico II

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TRHF - Placebo

Placebo - TRHF

Arm Description

Each subjects will receive both TRHF and placebo formula during the 1st part of the study

Each subjects will receive both TRHF and placebo formula during the 1st part of the study

Outcomes

Primary Outcome Measures

hypoallergenicity
the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula).

Secondary Outcome Measures

Regurgitations
assessed through Vandenplas score ranging from 0 (=less than 2 regurgitation episodes / day) to 6 (=Regurgitation of the complete volume after each feeding)
Vomiting
(on a 4 level scale)
Abdominal pain
(severity on a 4 level scale)
Bloating and gas
(severity on a 4 level scale)
Stool consistency
assessed through Bristol Stools Form Scale from Type A ( Separate hard lumps, like nuts (hard to pass)) to Type G (Watery, not solid pieces - entirely liquid )
Stool frequency
(number of stool per day or per week)
Blood in stools
(presence/absence)
Sleeping time over 24h satisfaction
(presence/absence)
Unexplained crying
(yes/no)
Respiratory symptoms
(severity on a 4 level scale)
Urticaria
(presence/absence)
Angioedema
(presence/absence)
Eczema
severity assessed through SCORAD
Weight
expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards
Height
expressed in cm and in z scores according to the WHO Child Growth Standards
BMI
expressed in value and z scores according to the WHO Child Growth Standards
Head circumference
expressed in cm and in z scores according to the WHO Child Growth Standards
Number of patients with treatment emergent Adverse Events

Full Information

First Posted
May 14, 2018
Last Updated
November 3, 2020
Sponsor
United Pharmaceuticals
Collaborators
Statitec
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1. Study Identification

Unique Protocol Identification Number
NCT03557671
Brief Title
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins
Official Title
Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins (TRHF 2017) in Children With Confirmed Immunoglobulin E (IgE) or Non-immunoglobulin E-mediated Cow's Milk Allergy (CMA)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 23, 2018 (Actual)
Primary Completion Date
September 21, 2020 (Actual)
Study Completion Date
September 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United Pharmaceuticals
Collaborators
Statitec

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.
Detailed Description
The study is made of 2 different steps : 1st step is a double blind randomised food challenge where the new formula is compared to a placebo. The second part of the trial consists in an open phase during which all infants will be fed with the study formula.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow Milk Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TRHF - Placebo
Arm Type
Experimental
Arm Description
Each subjects will receive both TRHF and placebo formula during the 1st part of the study
Arm Title
Placebo - TRHF
Arm Type
Placebo Comparator
Arm Description
Each subjects will receive both TRHF and placebo formula during the 1st part of the study
Intervention Type
Dietary Supplement
Intervention Name(s)
rice formula
Intervention Description
new rice based thickened formula
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
formula previously tolerated by the subject - only for the 1st part of the study
Primary Outcome Measure Information:
Title
hypoallergenicity
Description
the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula).
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Regurgitations
Description
assessed through Vandenplas score ranging from 0 (=less than 2 regurgitation episodes / day) to 6 (=Regurgitation of the complete volume after each feeding)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Vomiting
Description
(on a 4 level scale)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Abdominal pain
Description
(severity on a 4 level scale)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Bloating and gas
Description
(severity on a 4 level scale)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Stool consistency
Description
assessed through Bristol Stools Form Scale from Type A ( Separate hard lumps, like nuts (hard to pass)) to Type G (Watery, not solid pieces - entirely liquid )
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Stool frequency
Description
(number of stool per day or per week)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Blood in stools
Description
(presence/absence)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Sleeping time over 24h satisfaction
Description
(presence/absence)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Unexplained crying
Description
(yes/no)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Respiratory symptoms
Description
(severity on a 4 level scale)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Urticaria
Description
(presence/absence)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Angioedema
Description
(presence/absence)
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Eczema
Description
severity assessed through SCORAD
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Weight
Description
expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Height
Description
expressed in cm and in z scores according to the WHO Child Growth Standards
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
BMI
Description
expressed in value and z scores according to the WHO Child Growth Standards
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Head circumference
Description
expressed in cm and in z scores according to the WHO Child Growth Standards
Time Frame
1, 2, 3, 4, 5 and 6 months
Title
Number of patients with treatment emergent Adverse Events
Time Frame
1, 2, 3, 4, 5 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: with suspected CMA or with a CMA diagnosed by a DBPCFC performed in the last 2 months prior to inclusion free of clinical allergic symptoms for at least one week (i.e. successfully fed an elimination diet); whose parents signed the informed consent Exclusion Criteria: mainly breast fed, drinking less than 250ml of formula/day, presenting any situation, which, according to the investigator, may interfere with the study participation or lead to a particular risk for the subject
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberto Berni Canani
Organizational Affiliation
University Federico II
Official's Role
Study Director
Facility Information:
Facility Name
CHR Namur
City
Namur
Country
Belgium
Facility Name
Hôpital Saint Vincent de Paul - GHICL
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Trousseau
City
Paris
Country
France
Facility Name
University of Naples Federico II
City
Naples
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins

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