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

Not Applicable

Completed

• Conditions: Cow Milk Allergy
• Interventions: Dietary Supplement: rice formula; Dietary Supplement: placebo

• Registration Number: NCT03557671
• Lead Sponsor: United Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-15
• Study Start: 2018-08-23
• Primary Completion: 2020-09-21
• Study Completion: 2020-09-21
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TRHF - Placebo	rice formula	Each subjects will receive both TRHF and placebo formula during the 1st part of the study
Placebo - TRHF	placebo	Each subjects will receive both TRHF and placebo formula during the 1st part of the study
TRHF - Placebo	placebo	Each subjects will receive both TRHF and placebo formula during the 1st part of the study
Placebo - TRHF	rice formula	Each subjects will receive both TRHF and placebo formula during the 1st part of the study

Primary Outcome Measures

Name	Time	Method
hypoallergenicity	7 days	the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula).

Secondary Outcome Measures

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

Trial Locations

Locations (4)

University of Naples Federico II; 🇮🇹 Naples, Italy

Hopital Trousseau; 🇫🇷 Paris, France

Hôpital Saint Vincent de Paul - GHICL; 🇫🇷 Lille, France

CHR Namur; 🇧🇪 Namur, Belgium