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

Cow Milk Allergy Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03557671
• Other study ID #: UP2017-Promyce
• Status: Completed
• Phase: N/A
• Start date: August 23, 2018
• Est. completion date: September 21, 2020

Study information

• Verified date: November 2020
• Source: United Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: September 21, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Cow Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Dietary Supplement:
• rice formula
new rice based thickened formula
• placebo
formula previously tolerated by the subject - only for the 1st part of the study

Locations

Country	Name	City	State
Belgium	CHR Namur	Namur
France	Hôpital Saint Vincent de Paul - GHICL	Lille
France	Hopital Trousseau	Paris
Italy	University of Naples Federico II	Naples

Sponsors (2)

Lead Sponsor	Collaborator
United Pharmaceuticals	Statitec

Countries where clinical trial is conducted

Belgium,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hypoallergenicity	the percentage of children tolerating the formula during the double blind placebo controlled food challenge (TRHF 2017 vs. placebo formula).	7 days
Secondary	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
Secondary	Vomiting	(on a 4 level scale)	1, 2, 3, 4, 5 and 6 months
Secondary	Abdominal pain	(severity on a 4 level scale)	1, 2, 3, 4, 5 and 6 months
Secondary	Bloating and gas	(severity on a 4 level scale)	1, 2, 3, 4, 5 and 6 months
Secondary	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
Secondary	Stool frequency	(number of stool per day or per week)	1, 2, 3, 4, 5 and 6 months
Secondary	Blood in stools	(presence/absence)	1, 2, 3, 4, 5 and 6 months
Secondary	Sleeping time over 24h satisfaction	(presence/absence)	1, 2, 3, 4, 5 and 6 months
Secondary	Unexplained crying	(yes/no)	1, 2, 3, 4, 5 and 6 months
Secondary	Respiratory symptoms	(severity on a 4 level scale)	1, 2, 3, 4, 5 and 6 months
Secondary	Urticaria	(presence/absence)	1, 2, 3, 4, 5 and 6 months
Secondary	Angioedema	(presence/absence)	1, 2, 3, 4, 5 and 6 months
Secondary	Eczema	severity assessed through SCORAD	1, 2, 3, 4, 5 and 6 months
Secondary	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
Secondary	Height	expressed in cm and in z scores according to the WHO Child Growth Standards	1, 2, 3, 4, 5 and 6 months
Secondary	BMI	expressed in value and z scores according to the WHO Child Growth Standards	1, 2, 3, 4, 5 and 6 months
Secondary	Head circumference	expressed in cm and in z scores according to the WHO Child Growth Standards	1, 2, 3, 4, 5 and 6 months
Secondary	Number of patients with treatment emergent Adverse Events		1, 2, 3, 4, 5 and 6 months