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

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)

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.

Study Overview

• Status: Completed
• Conditions: Cow Milk Allergy
• Intervention / Treatment: Dietary supplement: rice formula; Dietary supplement: placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Namur, Belgium
    • CHR Namur
• France
  • Lille, France, 59000
    • Hôpital Saint Vincent de Paul - GHICL
  • Paris, France
    • Hôpital Trousseau
• Italy
  • Naples, Italy
    • University of Naples Federico II

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRHF - Placebo; Each subjects will receive both TRHF and placebo formula during the 1st part of the study	Dietary supplement: rice formula; new rice based thickened formula; Dietary supplement: placebo; formula previously tolerated by the subject - only for the 1st part of the study
Placebo Comparator: Placebo - TRHF; Each subjects will receive both TRHF and placebo formula during the 1st part of the study	Dietary supplement: rice formula; new rice based thickened formula; Dietary supplement: placebo; formula previously tolerated by the subject - only for the 1st part of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hypoallergenicity	the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula).	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regurgitations	assessed through Vandenplas score ranging from 0 (=less than 2 regurgitation episodes / day) to 6 (=Regurgitation of the complete volume after each feeding)	1, 2, 3, 4, 5 and 6 months
Vomiting	(on a 4 level scale)	1, 2, 3, 4, 5 and 6 months
Abdominal pain	(severity on a 4 level scale)	1, 2, 3, 4, 5 and 6 months
Bloating and gas	(severity on a 4 level scale)	1, 2, 3, 4, 5 and 6 months
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 )	1, 2, 3, 4, 5 and 6 months
Stool frequency	(number of stool per day or per week)	1, 2, 3, 4, 5 and 6 months
Blood in stools	(presence/absence)	1, 2, 3, 4, 5 and 6 months
Sleeping time over 24h satisfaction	(presence/absence)	1, 2, 3, 4, 5 and 6 months
Unexplained crying	(yes/no)	1, 2, 3, 4, 5 and 6 months
Respiratory symptoms	(severity on a 4 level scale)	1, 2, 3, 4, 5 and 6 months
Urticaria	(presence/absence)	1, 2, 3, 4, 5 and 6 months
Angioedema	(presence/absence)	1, 2, 3, 4, 5 and 6 months
Eczema	severity assessed through SCORAD	1, 2, 3, 4, 5 and 6 months
Weight	expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards	1, 2, 3, 4, 5 and 6 months
Height	expressed in cm and in z scores according to the WHO Child Growth Standards	1, 2, 3, 4, 5 and 6 months
BMI	expressed in value and z scores according to the WHO Child Growth Standards	1, 2, 3, 4, 5 and 6 months
Head circumference	expressed in cm and in z scores according to the WHO Child Growth Standards	1, 2, 3, 4, 5 and 6 months
Number of patients with treatment emergent Adverse Events		1, 2, 3, 4, 5 and 6 months

Collaborators and Investigators

• Sponsor: United Pharmaceuticals
• Collaborators: Statitec
• Investigators: Study Director: Roberto Berni Canani, University Federico II

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2018
• Primary Completion (Actual): September 21, 2020
• Study Completion (Actual): September 21, 2020

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: UP2017-Promyce

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No