Evaluating a special formula with synbiotics for infants with atopic dermatitis

Synbiotics in Partially Hydrolysed Formula for Improved skiN Barrier Function in Infants at Risk for Allergy (SPHINX Study)

This study is testing a special baby formula with added good bacteria to see if it can help prevent skin allergies in infants who are at risk.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 1 Day to 14 Days
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (Industry-sponsored)
• Locations: 23 sites (Bruges and 22 other locations)
• Trial ID: NCT06943469 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are infants aged 14 days or younger with a family history of allergies.

Not a fit: Patients who are not at risk for allergies or are older than 14 days may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of atopic dermatitis in infants at risk for allergies.

How similar studies have performed: Previous studies have shown promise in using hydrolyzed formulas for allergy prevention, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Bruges and 22 other locations

• AZ Sint-Jan Brugge-Oostende AV - Campus Sint-Jan — Bruges, Belgium (Recruiting)
• Universitair Ziekenhuis Brussel - Kinderziekenhuis — Brussels, Belgium (Recruiting)
• Clinique Ste Elisabeth — Namur, Belgium (Recruiting)
• CHU Amiens Picardie — Amiens, France (Recruiting)
• CHU de Caen — Caen, France (Recruiting)
• CHU de Grenoble Alpes — Grenoble, France (Recruiting)
• Hôpital de la Croix Rousse — Lyon, France (Recruiting)
• Hôpital Charles Nicolle — Rouen, France (Recruiting)
• CHRU de Tours — Tours, France (Recruiting)
• Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK) — Berlin, Germany (Not_yet_recruiting)
• Evangelisches Krankenhaus Düsseldorf - Frauenklinik — Düsseldorf, Germany (Recruiting)
• Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Frankfurt — Frankfurt, Germany (Recruiting)
• Evangelisches Waldkrankenhaus Spandau — Spandau, Germany (Recruiting)
• Marien Hospital Wesel GmbH — Wesel, Germany (Not_yet_recruiting)
• Hospital Teresa Herrera — A Coruña, Spain (Recruiting)
• HU Torrecárdenas — Almería, Spain (Recruiting)
• Hospital Quiron Salud Barcelona — Barcelona, Spain (Recruiting)
• Hospital Universitario Severo Ochoa — Madrid, Spain (Recruiting)
• Grupo Pediátrico Uncibay — Málaga, Spain (Recruiting)
• Instituto Hispalense de Pediatria (IHP) — Seville, Spain (Recruiting)
• Hospital Universitari de Tarragona Joan XXIII — Tarragona, Spain (Recruiting)
• Hospital Universitari Sant Joan de Reus — Tarragona, Spain (Recruiting)
• HCU Lozano Blesa — Zaragoza, Spain (Recruiting)

Study contacts

• Study coordinator: Amelie Goyer, PhD

Conditions Atopic Dermatitis