An observational study in Cow's Milk Protein Allergy (CMPA), Food Hypersensitivity and Infant Nutrition Disorders, sponsored by Outcomes'10. Recruiting at 13 sites in Spain. Open to participants aged Up to 10 Months. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Outcomes'10 · Observational
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.
Background and Rationale
Cow's milk protein allergy (CMPA) is a frequent condition in pediatric populations and a major cause of medical consultation during early infancy. Although prevalence estimates vary across studies, it is generally reported between 2% and 5%. CMPA can present with cutaneous, gastrointestinal, respiratory, or systemic symptoms and may impact growth, nutritional status, and family quality of life.
The cornerstone of management is dietary elimination of cow's milk protein. In infants requiring formula feeding, extensively hydrolyzed formulas (EHF) or amino acid-based formulas (AAF) are recommended, depending on allergy severity. Recent evidence suggests that gut microbiota composition plays a key role in the development and modulation of allergic diseases, and that prebiotics, probiotics, and synbiotics may beneficially modulate immune responses via the gut microbiome.
Almirón Pepti Syneo® is an extensively hydrolyzed whey-based formula that includes a symbiotic mixture (scGOS/lcFOS 9:1 and Bifidobacterium breve M-16V), the human milk oligosaccharide 2'-fucosyllactose (2'-FL), and a reduced content of purified lactose. Previous studies have demonstrated its safety, efficacy in managing CMPA symptoms, and support for adequate infant growth.
Objectives
Primary Objective:
- To evaluate the effect of an extensively hydrolyzed formula containing synbiotics and 2'-FL on physician-reported outcomes related to CMPA symptoms (cutaneous, respiratory, gastrointestinal, and/or systemic) in infants with suspected or confirmed CMPA.
Secondary Objectives:
Exploratory Objective:
- To explore the effect of the study formula on gut microbiota composition and stool characteristics in infants with suspected or confirmed CMPA.
Study Design
This is a prospective, longitudinal, open-label, single-arm, multicenter study conducted at approximately 13 primary care centers and one hospital (Hospital Quirón, Valencia, Spain). The study will enroll 41 infants under 10 months of age with suspected or recently confirmed CMPA.
Each infant will be followed for four weeks after the initiation of the study formula. Parents or legal guardians will complete standardized and ad hoc questionnaires regarding symptom evolution, gastrointestinal function, and product acceptability, while investigators will record clinical and anthropometric data using an electronic case report form (eCRF).
A subgroup of infants whose parents or guardians consent to the exploratory stool analysis will provide samples for microbiota assessment, processed at the sponsor's laboratories in Singapore and Utrecht.
Sample Size and Study Population
A total of 41 infants under 10 months of age with suspected or recently diagnosed CMPA will be recruited, assuming a 30% potential dropout rate. Infants with prior use of EHF, AAF, rice hydrolysate, or soy formulas will be excluded.
Variables
Collected data will include:
Study Duration
Recruitment will take place over approximately nine months. Each participant will be followed for four weeks.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's planned enrollment of 41 is below the median of 102 across 45 observational studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →Outcomes'10 is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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:
Time frame: Baseline (Visit 1) and Week 4 (Visit 2)
Change in parent-reported allergy symptom scores from baseline to Week 4
Change in parent- or caregiver-reported symptoms Differences between baseline and Week 4 will be analyzed and categorized according to improvement (reduction in score) or no improvement.
Time frame: Baseline and Week 4
Change in stool characteristics from baseline to Week 4
Parent-reported stool characteristics (consistency and color). Frequencies of stool types will be summarized for each visit, and changes over time will be described.
Time frame: Baseline and Week 4
Change in parental quality of life related to infant allergy from baseline to Week 4
Change in the Food Allergy Quality of Life-Parental Burden Questionnaire (FAQL-PB) score from baseline to Week 4. Improvement will be defined as a reduction in the total score. Descriptive statistics and frequencies of improvement will be presented.
Time frame: Baseline and Week 4
Change in infant anthropometric z-scores from baseline to Week 4
Change in z-scores for weight, length, and head circumference calculated according to World Health Organization (WHO) growth standards. Differences between baseline and Week 4 will be summarized using descriptive statistics.
Time frame: Baseline and Week 4
Parental acceptability and satisfaction with the study formula
Parent- or caregiver-reported acceptability and satisfaction with the study product. Frequencies of responses and consumption ratios (prepared vs. consumed product) will be summarized, and temporal trends will be described.
Time frame: At Week 4
Changes in gut microbiota composition after 4 weeks of formula use
Stool microbiota composition assessed through 16S rRNA gene sequencing (and optional metagenomics in a subset). Outcomes include relative abundance of Bifidobacterium spp. and Bifidobacterium breve, microbiota composition (beta diversity, stability, or maturation index), microbial diversity (alpha diversity), and differential abundance of bacterial taxa from phylum to species levels.
Time frame: Baseline and Week 4
Changes in microbial metabolites in stool samples
Concentrations and relative proportions of short-chain fatty acids levels in stool samples, measured by laboratory analysis.
Time frame: Baseline and Week 4
Changes in microbial metabolites in stool samples
Concentrations and relative proportions of ammonia levels in stool samples, measured by laboratory analysis.
Time frame: Baseline and Week 4
Changes in stool pH
Stool pH measured at baseline and Week 4 as an indicator of gut microbial activity and metabolic profile.
Time frame: Baseline and Week 4
Plan to share: No
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