Evaluation of an Adapted Formula on Atopic Dermatitis.

Study Overview
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Brief Summary
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The aim of this study is to show the efficiency of a new infant formula containing fiber on the management of moderate to severe atopic dermatitis.

Detailed Description
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The study is double blind randomized where the new formula is compared to a placebo during 3 months followed by a period of 3 months optional. During this period of time, all infant include in the study will be fed with the study formula.

Official Title
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Assessment of the Effect of Cow's Milk Protein-based Formulas for Infants in the Management of Moderate to Severe aTOPic Dermatitis in Infants Aged Less Than 18 Months

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Dietary Supplement: tested formula with fiber
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged below 18 month Having an atopic dermatitis diagnosed according to the United Kingdom Working Party - Having an Eczema Area Severity Index (EASI) between 7.1 and 50.0 Whose parents gave their informed consent Exclusion Criteria: systemic corticotherapy antihistamine use of dermocorticoide and/or antibiotics within 15 days symptoms of cutaneous infection Past anaphylactic shock cow's milk, soya or fish allergy Exclusive or predominant breast feediing (more than one feeding/day) Consumption of less than 500 ml per day Participation to another trial.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tested formula LP-2018<br>infant formula containing fibers | Dietary Supplement: tested formula with fiber<br>* formula containing fibers<br>|
| Placebo Comparator: Placebo formula CT-2018<br>infant formula without fibers | Dietary Supplement: Control<br>* formula without fiber<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EASI (Eczema Area Severity Index) score after 90 days. | evolution of the EASI score between day 0 to day 90. The score range is between 0 (no eczema) and 72 (highest score of eczema) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EASI (Eczema Area Severity Index) score after 30 days. | evolution of the EASI score between day 0 to day 30. The score range is between 0 (no eczema) and 72 (highest score of eczema) | 30 days | 
| EASI (Eczema Area Severity Index) score after 60 days. | evolution of the EASI score between day 0 to day 60. The score range is between 0 (no eczema) and 72 (highest score of eczema) | 60 days | 
| EASI (Eczema Area Severity Index) score after 180 days. | evolution of the EASI score between day 0 to day 180. The score range is between 0 (no eczema) and 72 (highest score of eczema) | 180 days | 
| PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution | Area under the curve of PO SCORAD | 30 days | 
| PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution | Area under the curve of PO SCORAD | 60 days | 
| PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution | Area under the curve of PO SCORAD | 90 days | 
| PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution | Area under the curve of PO SCORAD | 180 days | 
| Skin dryness | Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD | 30 days | 
| Skin dryness | Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD | 60 days | 
| Skin dryness | Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD | 90 days | 
| Skin dryness | Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD | 180 days | 
| Itching | Evolution of itching evaluated by the investigator using an analogic visual scale | 30 days | 
| Itching | Evolution of itching evaluated by the investigator using an analogic visual scale | 60 days | 
| Itching | Evolution of itching evaluated by the investigator using an analogic visual scale | 90 days | 
| Itching | Evolution of itching evaluated by the investigator using an analogic visual scale | 180 days | 
| Quality of sleep (assessed by VAS) | Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles) | 30 days | 
| Quality of sleep (assessed by VAS) | Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles) | 60 days | 
| Quality of sleep (assessed by VAS) | Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles) | 90 days | 
| Quality of sleep (assessed by VAS) | Evalution of the quality of sleep by the investigator using an analogic visual scale (from 0 to 10) (0 means no sleeping troubles and 10 mens very important troubles) | 180 days | 
| Sleep time | Evaluation of the duration of sleep by parents | 30 days | 
| Sleep time | Evaluation of the duration of sleep by parents | 60 days | 
| Sleep time | Evaluation of the duration of sleep by parents | 90 days | 
| Sleep time | Evaluation of the duration of sleep by parents | 180 days | 
| IDQoL (Infant's Dermatitis Quality of Life) | Evaluation of the infant's quality of life through the IDQoL (Infant's Dermatitis Quality of Life) | 90 days | 
| Use of topical dermocorticoids | The quantity and class of dermocorticoids used will be evaluated | 30 days | 
| Use of topical dermocorticoids | The quantity and class of dermocorticoids used will be evaluated | 60 days | 
| Use of topical dermocorticoids | The quantity and class of dermocorticoids used will be evaluated | 90 days | 
| Use of topical dermocorticoids | The quantity and class of dermocorticoids used will be evaluated | 180 days | 
| Atopic dermatitis flare | The number of flare will be evaluated | 30 days | 
| Atopic dermatitis flare | The number of flare will be evaluated | 60 days | 
| Atopic dermatitis flare | The number of flare will be evaluated | 90 days | 
| Atopic dermatitis flare | The number of flare will be evaluated | 180 days | 
| Weight | Weight evolution | 30 days | 
| Weight | Weight evolution | 60 days | 
| Weight | Weight evolution | 90 days | 
| Weight | Weight evolution | 180 days | 
| Length/Height | Length/Height evolution | 30 days | 
| Length/Height | Length/Height evolution | 60 days | 
| Length/Height | Length/Height evolution | 90 days | 
| Length/Height | Length/Height evolution | 180 days | 
| Regurgitations | Evolution of the daily number of regurgitations | Day 30 | 
| Regurgitations | Evolution of the daily number of regurgitations | Day 60 | 
| Regurgitations | Evolution of the daily number of regurgitations | Day 90 | 
| Regurgitations | Evolution of the daily number of regurgitations | Day 180 | 
| Stool's frequency | Evolution of the number of stools per day through a qualitative scale | Day 30 | 
| Stool's frequency | Evolution of the number of stools per day through a qualitative scale | Day 60 | 
| Stool's frequency | Evolution of the number of stools per day through a qualitative scale | Day 90 | 
| Stool's frequency | Evolution of the number of stools per day through a qualitative scale | Day 180 | 
| Stool's consistency | Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale | Day 30 | 
| Stool's consistency | Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale | Day 60 | 
| Stool's consistency | Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale | Day 90 | 
| Stool's consistency | Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale | Day 180 | 
| Gas, bloating | Evolution of presence/absence of gas, bloating | Day 30 | 
| Gas, bloating | Evolution of presence/absence of gas, bloating | Day 60 | 
| Gas, bloating | Evolution of presence/absence of gas, bloating | Day 90 | 
| Gas, bloating | Evolution of presence/absence of gas, bloating | Day 180 | 
| Satisfaction of the parents | Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas | Day 30 | 
| Satisfaction of the parents | Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas | Day 60 | 
| Satisfaction of the parents | Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas | Day 90 | 
| Satisfaction of the parents | Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas | Day 180 | 
| Satisfaction of the investigator | Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas | Day 30 | 
| Satisfaction of the investigator | Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas | Day 60 | 
| Satisfaction of the investigator | Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas | Day 90 | 
| Satisfaction of the investigator | Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas | Day 180 |