NCT05318300

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

May 24, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

March 18, 2022

Last Update Submit

December 7, 2023

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (64)

  • EASI (Eczema Area Severity Index) score after 30 days.

    30 days

  • EASI (Eczema Area Severity Index) score after 60 days.

    60 days

  • EASI (Eczema Area Severity Index) score after 180 days.

    180 days

  • PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution

    30 days

  • PO SCORAD (Patient Oriented-SCORing Atopic Dermatitis ) evolution

    60 days

  • +59 more secondary outcomes

Study Arms (2)

Tested formula LP-2018

EXPERIMENTAL

infant formula containing fibers

Dietary Supplement: tested formula with fiber

Placebo formula CT-2018

PLACEBO COMPARATOR

infant formula without fibers

Dietary Supplement: Control

Interventions

tested formula with fiberDIETARY_SUPPLEMENT

formula containing fibers

Tested formula LP-2018
ControlDIETARY_SUPPLEMENT

formula without fiber

Placebo formula CT-2018

Eligibility Criteria

Age1 Month - 18 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Center_13

Namur, Belgium

Location

Center_14

Thuin, Belgium

Location

Center_05

Nice, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary CarbohydratesCarbohydratesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Fabienne Cahn-Sellem

    Private Practice

    PRINCIPAL INVESTIGATOR

  • Sebastien Barbarot

    Hotel Dieu Hospital, Nantes, France

    STUDY CHAIR

  • Elena Bradatan

    Private Practice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2022

First Posted

April 8, 2022

Study Start

May 24, 2022

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)FR(1)