An interventional study of Test Formula and Placebo Formula in Cow's Milk Allergy, sponsored by United Pharmaceuticals. Active, not recruiting at 2 sites in 2 countries. Open to participants aged 1 Month to 24 Months. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by United Pharmaceuticals · Not applicable, Interventional, and Other
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.
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.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's planned enrollment of 70 is close to the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →United Pharmaceuticals is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Main Exclusion Criteria:
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,
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Infants will receive a placebo formula during the DBPCFC to compare against the test formula.
Hypoallergenicity of the formula
the percentage of children tolerating the formula during the double blind placebo controlled food challenge
Time frame: 7 days
Cow's Milk Related Symptom Score (CoMiSS™)
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).
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Atopic dermatitis severity - SCORing Atopic Dermatitis (SCORAD) Index
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.
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Gastrointestinal CMA symptoms
the other Gastrointestinal CMA symptoms (not described by the COMISS) will be reported (such as acute diarrhea, constipation...)
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Cutaneous CMA symptoms
Others Cutaneous CMA symptoms besides those evaluated in the CoMISS and the SCORAD will be described
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Sleep characteristics
This measures focuses on evaluating the quality and duration of sleep in children consuming the test.
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Weight
Weight will be expressed in kg and in z scores according to the World Health Organization (WHO) Child Growth Standards.
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
Height
Height will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
Head circumference
Head circumference will be expressed in cm and in z scores according to the WHO Child Growth Standards.
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
BMI
BMI will be expressed in value and z scores according to the WHO Child Growth Standards.
Time frame: At each monthly visit day 30, day 60, day 90 and day 120
Adverse event
Any untoward medical reaction occuring from the signatture of the consent until the end of the participant's participation
Time frame: During the whole study duration
Compliance
It will be assessed through the volume of formula consumed
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Parents' satisfaction
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)
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Investigator's satisfaction
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).
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Digestive tolerance
Digestive tolerance of the formula will be assessed by monitoring stool frequency and consistency, regurgitations, abdominal pain/painful flatus/ bloating, crying time, irritability time.
Time frame: At each visit : day7, day 30, day 60, day 90 and day 120
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
United Pharmaceuticals