Atopic Dermatitis
Conditions
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTtested formula with fiber
formula containing fibers
DIETARY_SUPPLEMENTControl
formula without fiber
Sponsors
United Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EASI (Eczema Area Severity Index) score after 90 days. | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EASI (Eczema Area Severity Index) score after 60 days. | 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) |
| EASI (Eczema Area Severity Index) score after 180 days. | 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) |
| PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution | 30 days | Area under the curve of PO SCORAD |
| Skin dryness | 30 days | Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD |
| Itching | 30 days | Evolution of itching evaluated by the investigator using an analogic visual scale |
| Quality of sleep (assessed by VAS) | 30 days | 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) |
| Sleep time | 30 days | Evaluation of the duration of sleep by parents |
| IDQoL (Infant's Dermatitis Quality of Life) | 90 days | Evaluation of the infant's quality of life through the IDQoL (Infant's Dermatitis Quality of Life) |
| Use of topical dermocorticoids | 30 days | The quantity and class of dermocorticoids used will be evaluated |
| EASI (Eczema Area Severity Index) score after 30 days. | 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) |
| Weight | 30 days | Weight evolution |
| Length/Height | 30 days | Length/Height evolution |
| Regurgitations | Day 30 | Evolution of the daily number of regurgitations |
| Stool's frequency | Day 30 | Evolution of the number of stools per day through a qualitative scale |
| Stool's consistency | Day 30 | Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale |
| Gas, bloating | Day 30 | Evolution of presence/absence of gas, bloating |
| Satisfaction of the parents | Day 30 | Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas |
| Satisfaction of the investigator | Day 30 | Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas |
| Atopic dermatitis flare | 30 days | The number of flare will be evaluated |
Countries
Belgium, France
Outcome results
None listed