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Active, Not Recruiting

NCT Number: NCT06481280

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cow's Milk Allergy Epilepsy, Idiopathic Generalized Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity Orofacial Cleft 1

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private practice Elena BRADATAN, Namur, Begium, Belgium

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About this study

Briefly, on two separate days, the placebo formula and the TEHCF will be introduced at increasing doses under medical supervision, and appearance of allergic symptoms will be witnessed and recorded if any. The week after, and more particularly the 72 hours after each food challenge day, child's parents will be instructed to report to the investigator any delayed reaction that may occur. In case the TEHCF induces an allergic reaction, the child's participation will be ended. Otherwise, the child will enter the second study part, lasting 4 months and during which the usual formula taken by the child will be totally replaced by the TEHCF.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • between 1 and 24 months old
  • having a CMA proven in the last 3 months prior to inclusion
  • 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.

Main Exclusion Criteria:

  • 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

Treatment and study plan

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

Dietary Supplement

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

Primary outcomes

  1. Hypoallergenicity of the formula

    Time frame: 7 days

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

Secondary outcomes

  1. Cow's Milk Related Symptom Score (CoMiSS™)

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

    The Cow's Milk Related Symptom Score (CoMiSS™) will be evaluated globally and each of its subscore. CoMiSS ranges from 0 to 33 (worst outcome).

  2. Atopic dermatitis severity - SCORing Atopic Dermatitis (SCORAD) Index

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

    Atopic dermatitis is assessed using the SCORing Atopic Dermatitis (SCORAD) Index. The score ranges from 0 to 103 (most severe state) and is used to determine the stages of severity of AD.

  3. Gastrointestinal CMA symptoms

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

    the other Gastrointestinal CMA symptoms (not described by the COMISS) will be reported (such as acute diarrhea, constipation...)

  4. Cutaneous CMA symptoms

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

    Others Cutaneous CMA symptoms besides those evaluated in the CoMISS and the SCORAD will be described

  5. Sleep characteristics

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

    This measures focuses on evaluating the quality and duration of sleep in children consuming the test.

  6. Weight

    Time frame: At each monthly visit day 30, day 60, day 90 and day 120

    Weight will be expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards.

  7. Height

    Time frame: At each monthly visit day 30, day 60, day 90 and day 120

    Height will be expressed in cm and in z scores according to the WHO Child Growth Standards.

  8. Head circumference

    Time frame: At each monthly visit day 30, day 60, day 90 and day 120

    Head circumference will be expressed in cm and in z scores according to the WHO Child Growth Standards.

  9. BMI

    Time frame: At each monthly visit day 30, day 60, day 90 and day 120

    BMI will be expressed in value and z scores according to the WHO Child Growth Standards.

  10. Adverse event

    Time frame: During the whole study duration

    Any untoward medical reaction occuring from the signatture of the consent until the end of the participant's participation

  11. Compliance

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

    It will be assessed through the volume of formula consumed

  12. Parents' satisfaction

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

    Satisfaction regarding the effect of the study formula on regurgitations, stool consistency, digestive comfort, and the acceptability of the formula by the child will be evaluated by using a 5-level satisfaction scale (very satisfied/satisfied/unsatisfied/very unsatisfied / without opinion)

  13. Investigator's satisfaction

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

    paediatrician's satisfaction with the effect of the study formula on the child) will be assessed by using a 4-level satisfaction scale (very satisfied/satisfied/unsatisfied/very unsatisfied).

  14. Digestive tolerance

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

    Digestive tolerance of the formula will be assessed by monitoring stool frequency and consistency, regurgitations, abdominal pain/painful flatus/ bloating, crying time, irritability time.

Sponsors and collaborators

Lead sponsor

United Pharmaceuticals

Industry

Collaborators

  • Slb Pharma

Registry information

Official study title

Cow's Milk Allergy (CMA): Evaluation of Tolerance, Efficacy and Safety of a Thickened Extensively Hydrolyzed Formula in Infants With IgE and Non-IgE Mediated CMA

Acronym: MERLIN

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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