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Evaluation of an Adapted Formula on Atopic Dermatitis.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 1 Month - 18 Months
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05318300
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

United Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Fabienne Cahn-SellemSebastien BarbarotElena Bradatan
Principal Investigator Affiliation Private PracticeHotel Dieu Hospital, Nantes, FrancePrivate Practice
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Belgium, France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Atopic Dermatitis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Tested formula LP-2018

infant formula containing fibers

Placebo Comparator: Placebo formula CT-2018

infant formula without fibers

Interventions

Dietary Supplement: - tested formula with fiber

formula containing fibers

Dietary Supplement: - Control

formula without fiber

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Center_13, Namur, Belgium

Status

Address

Center_13

Namur, ,

Center_14, Thuin, Belgium

Status

Address

Center_14

Thuin, ,

Center_05, Nice, France

Status

Address

Center_05

Nice, ,

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