Evaluation of Tolerance, Efficacy and Safety of an Hydrolyzed Formula in Infants With IgE/Non-IgE Mediated CMA.

NCT06481280 | Active Not Recruiting

• 1 other identifier: UP2022-01-MERLIN
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 2

Brief Summary

The aim of this interventional study is to assess the hypoallergenicity of a new formula in infants having a cow milk allergy (CMA), whatever the type of CMA, meaning in both IgE-mediated and non-IgE-mediated CMA patients. This will be tested through a double-blind placebo controlled food challenge (DBPCFC) taking place over 2 or 3 separate days, in hospital. If the child tolerates the tested formula during the DBPCFC, he will be fed with the test formula during the second study phase. There will be monthly visit and parents will be asked to fill in diaries.

Conditions

Cow's Milk Allergy

Keywords

CMA (Cow's Milk Allergy); DBPCFC (Double-Blind Placebo-Controlled Food Challenge); FA (Food Allergy); IgE (Immunoglobulin E); OFC (Oral Food Challenge)

Outcome Measures

Primary Outcomes (1)

• Hypoallergenicity of the formula

  the percentage of children tolerating the formula during the double blind placebo controlled food challenge

  7 days

Secondary Outcomes (14)

• Cow's Milk Related Symptom Score (CoMiSS™)

  At each visit : day7, day 30, day 60, day 90 and day 120

• Atopic dermatitis severity - SCORing Atopic Dermatitis (SCORAD) Index

  At each visit : day7, day 30, day 60, day 90 and day 120

• Gastrointestinal CMA symptoms

  At each visit : day7, day 30, day 60, day 90 and day 120

• Cutaneous CMA symptoms

  At each visit : day7, day 30, day 60, day 90 and day 120

• Sleep characteristics

  At each visit : day7, day 30, day 60, day 90 and day 120

Study Arms (2)

Test Formula

EXPERIMENTAL

Infants will receive an extensively hydrolyzed formula during the double-blind placebo-controlled food challenge (DBPCFC) and will continue on this formula during the open-label feeding phase if they tolerate it.

Dietary Supplement: Test Formula; Dietary Supplement: Placebo Formula

Placebo Formula

PLACEBO COMPARATOR

Infants will receive a placebo formula (=their previous formula) during the DBPCFC to compare against the test formula.

Dietary Supplement: Test Formula; Dietary Supplement: Placebo Formula

Interventions

Test Formula DIETARY_SUPPLEMENT

Infants will receive an extensively hydrolyzed formula during the double-blind placebo-controlled food challenge (DBPCFC) and will continue on this formula during the open-label feeding phase if they tolerate it.

Placebo Formula; Test Formula

Placebo Formula DIETARY_SUPPLEMENT

Infants will receive a placebo formula during the DBPCFC to compare against the test formula.

Placebo Formula; Test Formula

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• between 1 and 24 months old
• free of clinical allergic symptoms for at least one week (i.e., successfully fed an elimination diet)
• whose parent(s)/legal guardian(s) signed the informed consent form.

You may not qualify if:

• Children mainly (\>1 breastfeeding/day) or exclusively breastfed, with maternal willingness to continue breast-feeding
• Children with a mean formula intake lower than 250 ml/day
• Children with past anaphylactic reaction(s)
• Children with chronic (non acute) FPIES
• \-- Children presenting with any situation which, according to the investigator, may interfere with the study participation, or lead to a particular risk for the subject,
• Children already participating in another clinical trial

Sponsors & Collaborators

• United Pharmaceuticals: lead
• Slb Pharma: collaborator

Study Sites (2)

Private practice Elena BRADATAN

Namur, Begium, 5000, Belgium

Location

University Hospital - Umberto I Sapienza

Roma, 00161, Italy

Location

MeSH Terms

Conditions

Milk Hypersensitivity; Food Hypersensitivity; Epilepsy, Idiopathic Generalized; Orofacial Cleft 1

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Salvatore OLIVA, MD, PhD

  University Hospital - Umberto I

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking only applies to the 1st part of the study : during this part all parties (participant, care provide, investigator and outcomes assessor) will be blinded. The 2nd study part is open-label , there is no masking during this phase
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The first part of the study consists in a double-blind placebo-controlled food challenge (DBPCFC) during which all patient will receive the test formula and a placebo, in a randomised order. During the second part of the study, all patients will be fed the test formula (open-label phase).

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 1, 2024
• Study Start: August 14, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); IT (1)