Evaluation of an Adapted Formula on Atopic Dermatitis.

United Pharmaceuticals

Status: Active, not recruiting

Conditions: Atopic Dermatitis

Treatments: Dietary Supplement: Control; Dietary Supplement: tested formula with fiber

Study type: Interventional

Funder types: Industry

Identifiers

NCT05318300

UP2018-EFITOP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 1 to 18 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

126 participants in 2 patient groups, including a placebo group

Tested formula LP-2018

Experimental group

Description:

infant formula containing fibers

Treatment:

Dietary Supplement: tested formula with fiber

Placebo formula CT-2018

Placebo Comparator group

Description:

infant formula without fibers

Treatment:

Dietary Supplement: Control