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| Name | Class |
|---|---|
| Slb Pharma | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Placebo Formula | Placebo Comparator | Infants will receive a placebo formula (=their previous formula) during the DBPCFC to compare against the test formula. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoallergenicity of the formula | the percentage of children tolerating the formula during the double blind placebo controlled food challenge | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At each visit : day7, day 30, day 60, day 90 and day 120 |
| Atopic dermatitis severity - SCORing Atopic Dermatitis (SCORAD) Index |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore OLIVA, MD, PhD | University Hospital - Umberto I | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private practice Elena BRADATAN | Namur | Begium | 5000 | Belgium | ||
| University Hospital - Umberto I Sapienza |
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| ID | Term |
|---|---|
| D016269 | Milk Hypersensitivity |
| D005512 | Food Hypersensitivity |
| C562694 | Epilepsy, Idiopathic Generalized |
| C566121 | Orofacial Cleft 1 |
| ID | Term |
|---|---|
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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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).
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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
| Placebo Formula | Dietary Supplement | Infants will receive a placebo formula during the DBPCFC to compare against the test formula. |
|
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. |
| 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...) | 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 | 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. | 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. | 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. | 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. | 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. | 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 | During the whole study duration |
| Compliance | It will be assessed through the volume of formula consumed | 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) | 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). | 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. | At each visit : day7, day 30, day 60, day 90 and day 120 |
| Roma |
| 00161 |
| Italy |