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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tested formula LP-2018 | Experimental | infant formula containing fibers |
|
| Placebo formula CT-2018 | Placebo Comparator | infant formula without fibers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tested formula with fiber | Dietary Supplement | formula containing fibers |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabienne Cahn-Sellem | Private Practice | Principal Investigator |
| Sebastien Barbarot | Hotel Dieu Hospital, Nantes, France | Study Chair |
| Elena Bradatan | Private Practice | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center_13 | Namur | Belgium | ||||
| Center_14 |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| Control |
| Dietary Supplement |
formula without fiber |
|
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 |
| Thuin |
| Belgium |
| Center_05 | Nice | France |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |