Evaluating a special formula with synbiotics for infants with atopic dermatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a partially hydrolyzed formula containing synbiotics in preventing atopic dermatitis in infants who are at risk for allergies. The trial will compare the test formula against a control formula to assess various efficacy and safety parameters. Eligible infants will be those who are either exclusively breastfed or predominantly formula-fed, with a family history of allergies. The study will enroll infants within the first two weeks of life to monitor early intervention outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent has been obtained from at least one parent or legally acceptable representative (LAR), if applicable
2. Infant gestational age ≥ 37 completed weeks
3. Infant birth weight of ≥ 2.5 kg and ≤ 4.5 kg
4. Infant postnatal age ≤ 14 days (date of birth = day 0) at enrollment
5. Infant from singleton birth or infant from multiple births may if all birth siblings are enrolled.
6. At least one biological parent or sibling has (or had) a medically diagnosed history of allergy, based on response to a simple screening questionnaire
7. 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 age.

   or b. For the randomized formula-fed groups only: infant is exclusively or predominantly formula-fed in the 24 hours prior to enrollment, with formula feeding representing at least 75% of total daily feeds. The decision to introduce formula feeding was independently made by the parents before enrollment.
8. Parents/LAR must be able to provide evidence of parental authority and identity.
9. 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.

Exclusion Criteria:

1. Infectious, metabolic, congenital, genetic, gastrointestinal illness or any other condition (e.g., gastrointestinal surgery) that could impact oral feeding, growth or study outcomes.
2. 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.
3. Infant has already been diagnosed with allergy by a physician, including AD and/or cow's milk allergy.
4. Infant is currently participating or has previously participated in another clinical trial prior to enrollment.
5. Infant's parents or LARs have not reached legal age of majority (18 years).

Where it's running

• AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan
  Bruges, Belgium Recruiting
• Clinique Ste Elisabeth
  Namur, Belgium Recruiting
• CHU Amiens Picardie
  Amiens, France Recruiting
• CHU de Caen
  Caen, France Recruiting
• Hôpital de la Croix Rousse
  Lyon, France Recruiting
• Hôpital Charles Nicolle
  Rouen, France Recruiting

Study contacts

• Study coordinator: Amelie Goyer, PhD
• Email: Amelie.Goyer1@rd.nestle.com
• Phone: +41217858939

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Roflumilast Cream 0.3% for moderate to severe atopic dermatitis in children, adolescents, and adults

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  Recruiting Phase 2 Leadingtac Pharmaceutical (Shaoxing) Co., Ltd. · Hangzhou, Zhejiang · NCT07895615

• PRA-216 for moderate to severe atopic dermatitis: safety and how it works in the body

  This study tests PRA-216 versus placebo to see if it is safe and helps people with moderate to severe atopic dermatitis.

  Recruiting at 6 sites Phase 2 Prana Therapies Inc · Botany, New South Wales and 8 other locations · NCT07810777

• Skin structure in atopic dermatitis patients treated with nemolizumab assessed by reflectance confocal microscopy

  This study tests whether nemolizumab changes skin structure in adults with moderate-to-severe atopic dermatitis using a noninvasive imaging method.

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• Global Health Look at Atopic Dermatitis

  A worldwide, multicenter study tests how people with atopic dermatitis access care and treat it, using data from routine medical records.

  Recruiting University of Zurich · Zurich · NCT07659756

• Stapokibart Injection for atopic dermatitis in adults

  This study tests Stapokibart Injection in adults with atopic dermatitis to see how safe it is and whether it helps.

  Recruiting Chengdu Kangnuoxing Biopharma,Inc. · Beijing, Beijing Municipality · NCT07544862

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.