Evaluation of an Adapted Formula on Atopic Dermatitis.

Not Applicable

Active, not recruiting

• Conditions: Atopic Dermatitis
• Interventions: Dietary Supplement: tested formula with fiber; Dietary Supplement: Control

• Registration Number: NCT05318300
• Lead Sponsor: United Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-31
• Study First Posted: 2022-04-08
• Study Start: 2022-05-24
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-04
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 126

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tested formula LP-2018	tested formula with fiber	infant formula containing fibers
Placebo formula CT-2018	Control	infant formula without fibers

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Skin dryness	180 days	Evolution of skin dryness evaluated by the investigator using the dryness scale of the PO SCORAD
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)
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)
Satisfaction of the investigator	Day 180	Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
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	180 days	Area under the curve of PO SCORAD
Itching	180 days	Evolution of itching evaluated by the investigator using an analogic visual scale
Quality of sleep (assessed by VAS)	180 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)
Weight	180 days	Weight evolution
Use of topical dermocorticoids	180 days	The quantity and class of dermocorticoids used will be evaluated
Length/Height	180 days	Length/Height evolution
Atopic dermatitis flare	180 days	The number of flare will be evaluated
Regurgitations	Day 180	Evolution of the daily number of regurgitations
Stool's frequency	Day 180	Evolution of the number of stools per day through a qualitative scale
Stool's consistency	Day 180	Evolution of the stool's consistency using the Brussels Infant and Toddler Stool Scale
Gas, bloating	Day 180	Evolution of presence/absence of gas, bloating
Satisfaction of the parents	Day 180	Different levels of satisfaction (from bad to good/very good) on the use and efficiency of study formulas
Sleep time	180 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)

Trial Locations

Locations (3)

Center_13; 🇧🇪 Namur, Belgium

Center_05; 🇫🇷 Nice, France

Center_14; 🇧🇪 Thuin, Belgium