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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
126
formula containing fibers
formula without fiber
Center_13
Namur, Belgium
Center_14
Thuin, Belgium
Center_05
Nice, France
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)
Time frame: 90 days
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)
Time frame: 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)
Time frame: 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)
Time frame: 180 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Area under the curve of PO SCORAD
Time frame: 30 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Area under the curve of PO SCORAD
Time frame: 60 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
Area under the curve of PO SCORAD
Time frame: 90 days
PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Area under the curve of PO SCORAD
Time frame: 180 days
Skin dryness
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Time frame: 30 days
Skin dryness
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Time frame: 60 days
Skin dryness
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Time frame: 90 days
Skin dryness
Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
Time frame: 180 days
Itching
Evolution of itching evaluated by the investigator using an analogic visual scale
Time frame: 30 days
Itching
Evolution of itching evaluated by the investigator using an analogic visual scale
Time frame: 60 days
Itching
Evolution of itching evaluated by the investigator using an analogic visual scale
Time frame: 90 days
Itching
Evolution of itching evaluated by the investigator using an analogic visual scale
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 180 days
Sleep time
Evaluation of the duration of sleep by parents
Time frame: 30 days
Sleep time
Evaluation of the duration of sleep by parents
Time frame: 60 days
Sleep time
Evaluation of the duration of sleep by parents
Time frame: 90 days
Sleep time
Evaluation of the duration of sleep by parents
Time frame: 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)
Time frame: 90 days
Use of topical dermocorticoids
The quantity and class of dermocorticoids used will be evaluated
Time frame: 30 days
Use of topical dermocorticoids
The quantity and class of dermocorticoids used will be evaluated
Time frame: 60 days
Use of topical dermocorticoids
The quantity and class of dermocorticoids used will be evaluated
Time frame: 90 days
Use of topical dermocorticoids
The quantity and class of dermocorticoids used will be evaluated
Time frame: 180 days
Atopic dermatitis flare
The number of flare will be evaluated
Time frame: 30 days
Atopic dermatitis flare
The number of flare will be evaluated
Time frame: 60 days
Atopic dermatitis flare
The number of flare will be evaluated
Time frame: 90 days
Atopic dermatitis flare
The number of flare will be evaluated
Time frame: 180 days
Weight
Weight evolution
Time frame: 30 days
Weight
Weight evolution
Time frame: 60 days
Weight
Weight evolution
Time frame: 90 days
Weight
Weight evolution
Time frame: 180 days
Length/Height
Length/Height evolution
Time frame: 30 days
Length/Height
Length/Height evolution
Time frame: 60 days
Length/Height
Length/Height evolution
Time frame: 90 days
Length/Height
Length/Height evolution
Time frame: 180 days
Regurgitations
Evolution of the daily number of regurgitations
Time frame: Day 30
Regurgitations
Evolution of the daily number of regurgitations
Time frame: Day 60
Regurgitations
Evolution of the daily number of regurgitations
Time frame: Day 90
Regurgitations
Evolution of the daily number of regurgitations
Time frame: Day 180
Stool's frequency
Evolution of the number of stools per day through a qualitative scale
Time frame: Day 30
Stool's frequency
Evolution of the number of stools per day through a qualitative scale
Time frame: Day 60
Stool's frequency
Evolution of the number of stools per day through a qualitative scale
Time frame: Day 90
Stool's frequency
Evolution of the number of stools per day through a qualitative scale
Time frame: Day 180
Stool's consistency
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Time frame: Day 30
Stool's consistency
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Time frame: Day 60
Stool's consistency
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Time frame: Day 90
Stool's consistency
Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Time frame: Day 180
Gas, bloating
Evolution of presence/absence of gas, bloating
Time frame: Day 30
Gas, bloating
Evolution of presence/absence of gas, bloating
Time frame: Day 60
Gas, bloating
Evolution of presence/absence of gas, bloating
Time frame: Day 90
Gas, bloating
Evolution of presence/absence of gas, bloating
Time frame: Day 180
Satisfaction of the parents
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time frame: Day 30
Satisfaction of the parents
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time frame: Day 60
Satisfaction of the parents
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time frame: Day 90
Satisfaction of the parents
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time frame: Day 180
Satisfaction of the investigator
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time frame: Day 30
Satisfaction of the investigator
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time frame: Day 60
Satisfaction of the investigator
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time frame: Day 90
Satisfaction of the investigator
Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Time frame: Day 180