Formula Milk, Infants
Conditions
Keywords
Infants, Gut microbiome, Formula milk
Brief summary
This prospective, single-arm study evaluates the gastrointestinal tolerance, safety, and growth, quality of life and gut microbiome development of healthy term infants fed a commercially available palm oil free infant formula containing prebiotics and postbiotics derived from fermentation over a 24-week period. Infants aged 0 to 6 weeks who were exclusively formula-fed at enrolment received the study formula as their sole source of nutrition. The primary objective is to assess gastrointestinal tolerance and safety. Secondary objectives include assessment of infant quality of life, parental experience and to characterise the development of the infant gut microbiome. The study includes four visits over 24 weeks, during which clinical measurements, safety assessments, and sample collection are performed.
Interventions
OTHERInfant Formula
Cow's milk based infant formula with with prebiotics and postbiotics derived from fermentation
Sponsors
Nutricia UK Ltd
Atlantia Food Clinical Trials
Teagasc
University College Cork
Danone Global Research & Innovation Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. Parent's or legal guardian's aged 18 years, written informed consent. 2. Infants exclusively formula fed at enrolment and parents/legal guardians have autonomously decided to exclusively formula feed until the end of intervention. 3. Infants aged 0 to 6 weeks (day 0 to day 42 inclusive). 4. Healthy term singleton infants, gestational age \~ 37 and \< 42 weeks (i.e.,\~ 41 weeks+ 6 days). Healthy is defined as no supervision or medical treatment by a medical specialist. 5. Birth weight between 2.5 - 4.5 kg (within normal range for gestational age and sex, according to WHO definitions). 6. Willing to continue using the infant formula, during the study, not switching of formula, except for medical purposes in which case the infant would be excluded.
Exclusion criteria
1. Infants with congenital condition and/or previous or current illness and (or) medication use that could interfere with the study, in the opinion of the medical doctor. 2. Infants with established or suspected cows' milk allergy, lactose intolerance, galactosaemia, or infants on a prescribed fibre-free (e.g., prebiotic oligosaccharides) diet. 3. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study. 4. Investigator's uncertainty about the willingness or ability of the parents/legal guardians to comply with the protocol requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Tolerance - Stool consistency and frequency | 24 weeks | Gastrointestinal tolerance evaluated with stool consistency and stool frequency for 3 consecutive days after first intake of study product and before each visit at week 2, week 10, and week 24 of intervention. |
| Gastrointestinal Tolerance - Pediatric Quality of Life Inventory (PedsQL) | 24 weeks | Scores are transformed to a 0 to 100 scale, with higher scores indicating better health-related quality of life and fewer problems. PedsQL to assess infant's quality of life at baseline and week 2, week 10, and week 24. |
| Gastrointestinal Tolerance - Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) | 24 weeks | The IGSQ-13 consists of 13 items with a total score ranging from 13 to 65, where lower scores indicate better gastrointestinal tolerance and fewer symptoms, and higher scores indicate greater gastrointestinal distress. IGSQ-13 questionnaire to asses gastrointestinal tolerance at baseline and week 2, week 10, and week 24. |
| Safety - Growth (Weight) | 24 weeks | Safety parameters included weight gain measured at baseline, week 2, week 10, and week 24 of intervention. |
| Safety - Growth (Length) | 24 weeks | Safety parameters included length gain measured at baseline, week 2, week 10, and week 24 of intervention. |
| Safety - Growth (Head circumference) | 24 weeks | Safety parameters included head circumference measured at baseline, week 2, week 10, and week 24 of intervention. |
| Safety - Adverse Events | 24 weeks | Occurrence of (serious) AE measured throughout the intervention period. |
Countries
Ireland
Contacts
PRINCIPAL_INVESTIGATORCatherine Stanton
Teagasc
Outcome results
None listed