SMASH: Study to Evaluate the Clinical Efficacy of an Extensively Hydrolysed Infant Formula With Synbiotics and a Human Milk Oligosaccharide (HMO) in Infants With Cow's Milk Protein Allergy (CMPA)

NCT07342621 | Recruiting

• 1 other identifier: NUT-2023-185-APLV
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 13

Brief Summary

Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with an estimated prevalence between 2% and 5%. The number of diagnosed cases has increased in recent years, with clinical manifestations involving the gastrointestinal tract, respiratory system, skin, or systemic reactions. Dietary elimination of cow's milk protein remains the mainstay of treatment, using extensively hydrolyzed formulas (EHF) or amino acid-based formulas (AAF), depending on the severity of the allergy. This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed whey-based formula (Almirón Pepti Syneo®) containing a symbiotic mixture (scGOS/lcFOS 9:1 and Bifidobacterium breve M-16V), the human milk oligosaccharide 2'-fucosyllactose (2'-FL), and a reduced amount of purified lactose, in infants with suspected or confirmed CMPA in a real-world clinical practice setting. This is a prospective, longitudinal, open-label, single-arm, multicenter study including approximately 41 infants under 10 months of age at several primary care centers and one hospital in Valencia, Spain. Each participant will be followed for four weeks. A subgroup of participants will also provide stool samples to explore the effect of the study formula on gut microbiota composition.

Conditions

Cow's Milk Protein Allergy (CMPA); Food Hypersensitivity; Infant Nutrition Disorders; Gut Microbiota

Keywords

Extensively Hydrolyzed Formula; Synbiotics; Cow's Milk Protein Allergy; Real World Evidence; Microbiota; Gastrointestinal Symptoms

Outcome Measures

Primary Outcomes (1)

• Change in investigator-reported allergy symptom scores

  Change from baseline to Week 4 in investigator-assessed allergy symptoms in infants with suspected or confirmed cow's milk protein allergy, measured using four validated or ad hoc instruments:

  Baseline (Visit 1) and Week 4 (Visit 2)

Secondary Outcomes (5)

• Change in parent-reported allergy symptom scores from baseline to Week 4

  Baseline and Week 4

• Change in stool characteristics from baseline to Week 4

  Baseline and Week 4

• Change in parental quality of life related to infant allergy from baseline to Week 4

  Baseline and Week 4

• Change in infant anthropometric z-scores from baseline to Week 4

  Baseline and Week 4

• Parental acceptability and satisfaction with the study formula

  At Week 4

Other Outcomes (4)

• Changes in gut microbiota composition after 4 weeks of formula use

  Baseline and Week 4

• Changes in microbial metabolites in stool samples

  Baseline and Week 4

• Changes in microbial metabolites in stool samples

  Baseline and Week 4

Study Arms (1)

Infants with suspected or confirmed CMPA

Eligibility Criteria

• Age: Up to 10 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants under 10 months of age with suspected or recently confirmed cow's milk protein allergy (CMPA) who are initiating the use of a hypoallergenic formula as part of routine clinical management. All participants will receive an extensively hydrolyzed whey-based formula containing synbiotics and 2'-fucosyllactose (2'-FL) and will be followed prospectively for four weeks.

You may qualify if:

• Infants under 10 months of age at study start (Visit 1).
• Suspected or recently confirmed cow's milk protein allergy (CMPA), as determined by the investigator.
• Already formula-fed, or parents/legal guardians have decided to initiate formula feeding.
• Written informed consent obtained from parents or legal guardians in accordance with local regulations.

You may not qualify if:

• Infants with functional gastrointestinal symptoms in whom atopy or food allergy is not suspected.
• Infants who have previously used an extensively hydrolyzed formula (EHF), an amino acid-based formula (AAF), a rice hydrolysate formula, or a soy-based formula.
• Infants who have previously used a partially hydrolyzed formula for the prevention of cow's milk protein allergy (CMPA).
• Infants for whom an amino acid-based formula (AAF) is more appropriate as first-line management, including severe forms of CMPA.
• Contraindications to the use of synbiotics (e.g., preterm infants \<40 weeks of corrected gestational age at study start, immunodeficiency, short bowel syndrome, parenteral nutrition, post-pyloric feeding, central venous catheter, oncology treatment, or graft-versus-host disease).
• Any other condition, as assessed by the investigator, that contraindicates the use of an extensively hydrolyzed formula.
• Any other circumstance, as assessed by the investigator, indicating that the parents or legal guardians are not capable of complying with the study procedures.

Sponsors & Collaborators

• Outcomes'10: lead

Study Sites (13)

Quironsalud Valencia Hospital

Valencia, Valencia, 46004, Spain

RECRUITING

Trinitat Health centre

Valencia, Valencia, 46010, Spain

RECRUITING

Malva-rosa Health centre

Valencia, Valencia, 46011, Spain

RECRUITING

República Argentina Health centre

Valencia, Valencia, 46021, Spain

RECRUITING

Salvador Pau Health centre

Valencia, Valencia, 46021, Spain

RECRUITING

Serrería 2 Health Centre

Valencia, Valencia, 46022, Spain

RECRUITING

Serrería I Health Centre

Valencia, Valencia, 46022, Spain

RECRUITING

Trafalgar Health centre

Valencia, Valencia, 46023, Spain

RECRUITING

Miguel Servet Health centre

Valencia, Valencia, 46025, Spain

RECRUITING

Alboraya Health centre

Valencia, Valencia, 46120, Spain

RECRUITING

Trinitat Health centre

Valencia, Valencia, 46160, Spain

RECRUITING

Cañada Health centre

Valencia, Valencia, 46182, Spain

RECRUITING

Eliana Health centre

Valencia, Valencia, 46183, Spain

RECRUITING

MeSH Terms

Conditions

Milk Hypersensitivity; Food Hypersensitivity; Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Central Study Contacts

Mónica Rodríguez, Medical Manager Peads

CONTACT

662 150 840; monica.rodriguez@danone.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: January 15, 2026
• Study Start: February 7, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 1, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (13)