NCT04662619Completed
A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis
A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled, Two-Arm, Parallel-Group, Nutritional Intervention Study to Examine the Clinical and Immunological Effects of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants at Risk of Developing Atopic Dermatitis
Source: ClinicalTrials.gov · Last updated 16 Dec 2024
Brief summary (registry, in English)
The purpose of this study is to assess the effect of B. infantis (EVC001) versus placebo supplementation, in healthy breastfed infants at risk of developing atopic dermatitis (AD), on cumulative incidence of physician-diagnosed AD during the first year of life.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 273 (actual)
- First submitted
- 26 Nov 2020
- Start date
- 18 Dec 2020
- Primary completion date
- 7 Dec 2023
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT04662619
What you commit to
- Study type: Interventional
- Participants enrolled: 273
- From 18 Dec 2020 to the primary completion date, 7 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has consumed greater than (\>)100 milliliter (mL) of formula per day within the 48 hours prior to enrollment (Day 0)
- Has a history of confirmed coronavirus disease 2019 (COVID-19) within 30 days prior to any on-site visit
- Within 14 days prior to Visit 1, has been in close contact (exposure within 6 feet for a cumulative time of 15 minutes or more over a 24-hour period) with anyone who has a confirmed case of COVID-19
- Has had self-reported (for Caregiver) or parent-reported (for infant) symptoms of COVID-19 within 14 days prior to the screening visit, such as unexplained cough, shortness of breath/difficulty breathing, fatigue, body aches (headaches, muscle pain, stomachaches), conjunctivitis, loss of smell, loss of taste, poor appetite, nausea, vomiting, diarrhea, palpitations, or chest pain/tightness
Other illness
- Evidence of a baseline illness/condition (example abnormal birth weight) or significant risk of developing an illness/condition (based on review of maternal/pregnancy information) that would, in the opinion of the Principal Investigator (PI) or designee, introduce a significant safety concern if the infant were enrolled in the study or otherwise preclude study participation
- Significant birth defect/complication that would, in the opinion of the PI or designee, create a safety concern or otherwise confound the study (example, abdominal wall defects, congenital heart disease)
- Severe widespread skin condition (example collodion)
- Is under a COVID-19 isolation/quarantine order
Age
- Preterm delivery (\< 36 weeks \[252 days\] gestational age)
Other
- Admission to the neonatal unit for issues other than establishment of normal feeding
- Twin or multiple births
- Atopic dermatitis (AD) diagnosed at Day 0
Who the study is looking for
- Healthy term infant
- Has at least one first degree relative (that is biological parent or full sibling) with a history of atopic disease (that is mother-reported, physician-diagnosed Atopic Dermatitis (AD), allergic rhinitis, or asthma)
- Breastfeeding established (as determined by the principal Investigator \[PI\] or designee) at the time of study enrollment (Day 0), with maternal intent to maintain exclusive breastfeeding for greater than or equal to (\>=)12 weeks
- Will participate in the study under supervision of his/her biological mother ("Caregiver") who is: a) At least 18 years old b) The legal guardian of the infant c) Intending to cohabitate with the infant for the duration of the study d) Willing to follow all Caregiver responsibilities e) Fluent in Finnish, Swedish, or English
- The PI considers the Caregiver likely to adequately comply with the study protocol requirements based on demonstrated compliance with antenatal appointments and agreement to complete the intuitive, interactive, electronic diary (eDiary) utilizing personal smart device (example, tablet, cell phone)
Age in the registry: - to 14 days · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| HUS Children and Adolescents, Clinical Trial Unit, Park Hospital Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.