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New treatment option for Atopic Dermatitis (AD)
Official title Effect of Partially Hydrolyzed Formula With Synbiotics on Skin Barrier Function
ClinicalTrials.gov ID: NCT06943469
What this study is testing
- What it's testing
- The main purpose of this study is to assess the efficacy of a partially hydrolyzed formula with synbiotics in halting one of the first steps of the allergic march (atopic dermatitis) in infants at risk of allergy. Other efficacy and safety parameters will be assessed as well.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 14. Healthy volunteers may be eligible.
You may be able to join if
- Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable
- Infant gestational age ≥ 37 completed weeks
- Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
- Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment
- Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
You likely can't join if
- Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral...
- Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for...
- Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
- Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
- Infant's parents or LARs have not reached legal age of majority (18 years).
See the full eligibility criteria
- Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable
- Infant gestational age ≥ 37 completed weeks
- Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
- Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment
- Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
- At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
- a. For the breastfed reference group only: infant is exclusively breastfed since birth with no intake of formula, and their parent(s) have the intention to continue exclusive breastfeeding until at least 4 months of...
- Parents/LAR must be able to provide evidence of parental authority and identity.
- Infant's parent(s)/LAR must understand the informed consent form and other study documents and are willing and able to fulfill the requirements of the study protocol.
- Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.
- Infants with special dietary needs other than standard infant formula (e.g., extensively hydrolyzed formula, amino acid formula, special formula for metabolic diseases) or requiring tube feeding.
- Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
- Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
- Infant's parents or LARs have not reached legal age of majority (18 years).
The study team makes the final eligibility decision.
Where it's taking place
- Bruges, Belgium
- Brussels, Belgium
- Namur, Belgium
- Amiens, France
- Caen, France
- Grenoble, France
- Lyon, France
- Rouen, France
- Tours, France
- Berlin, Germany
- Düsseldorf, Germany
- Frankfurt, Germany
- Spandau, Germany
- Wesel, Germany
- A Coruña, Spain
- Almería, Spain
- Barcelona, Spain
- Madrid, Spain
- Málaga, Spain
- Seville, Spain
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 14 days. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bruges, Belgium; Brussels, Belgium; Namur, Belgium; Amiens, France; Caen, France; Grenoble, France and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.