Evaluation of the Hypoallergenicity of an Extensively Hydrolyzed Formula

Phase 3

Completed

• Conditions: Cow Milk Allergy
• Interventions: Dietary Supplement: Amino acid formula; Dietary Supplement: Extensively Hydrolyzed formula

• Registration Number: NCT02711163
• Lead Sponsor: United Pharmaceuticals

Brief Summary

The aim of this study is to assess the hypoallergenicity of a new thickened extensively hydrolyzed formula, in infants with confirmed cow's milk protein allergy assessed through a double blind placebo controlled food challenge, followed by a 3-month open feeding period.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-17
• Study Start: 2016-04
• Primary Completion: 2017-08-31
• Study Completion: 2017-11-29
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-14
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Infants:

• with cow's milk allergy confirmed by a double-blind food challenge performed in the last 2 months,
• successfully fed an eviction diet for at least 2 weeks

Main Non-inclusion Criteria:

Infants:

• fed with an extensively hydrolyzed formula with no improvement of the symptoms,
• who refused to drink an extensively hydrolyzed formula anytime prior to inclusion,
• fed a vegetable based formula
• fed an amino acid based formula or who should be fed with an amino acid based formula according to recommendations
• who had an anaphylactic reaction in the past

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Amino acid formula	Amino acid formula	Feeding amino acid formula
Extensively hydrolyzed formula	Extensively Hydrolyzed formula	Feeding extensively hydrolyzed formula

Primary Outcome Measures

Name	Time	Method
Percentage of infants tolerating the formula during a double blind placebo controlled food challenge	7 days

Secondary Outcome Measures

Name	Time	Method
Duration of crying over 24h	7, 45 and 90 days
Regurgitation assessed through Vandenplas score	7, 45 and 90 days
Abdominal pain (severity on a 4 level scale)	7, 45 and 90 days
Weight expressed in z scores according to the WHO Child Growth Standards	45 and 90 days
Stool consistency assessed through Bristol Stools Form Scale	7, 45 and 90 days
Urticaria (presence/absence)	7, 45 and 90 days
Eczema assessed through SCORAD	7, 45 and 90 days
Vomiting (weekly frequency)	7, 45 and 90 days
Bloating and gas (severity on a 4 level scale)	7, 45 and 90 days
Sleeping time over 24h	7, 45 and 90 days
Stool frequency over 72h	7, 45 and 90 days
Blood in stools (presence/absence)	7, 45 and 90 days
Respiratory symptoms (severity on a 4 level scale)	7, 45 and 90 days
Height expressed in z scores according to the WHO Child Growth Standards	45 and 90 days
BMI expressed in z scores according to the WHO Child Growth Standards	45 and 90 days
Head circumference expressed in z scores according to the WHO Child Growth Standards	45 and 90 days
Number of patients with treatment emergent Adverse Events	7, 45 and 90 days

Trial Locations

Locations (1)

Umberto I university hospital; 🇮🇹 Roma, Italy