Clinical trial NCT06073652: Starter Infant Formula With Synbiotics
Official title: Safety and Efficacy of a Starter Infant Formula With Synbiotics: a Double-blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthy Infants
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2023-10-10
Enrollment: 240
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This randomized, double-blind, controlled intervention trial aims to evaluate the safety and efficacy of a starter infant formula supplemented with an HMO blend and a probiotic, and will provide evidence on the safety and efficacy of the innovative prebiotic/ probiotic blend to support age-appropriate infant growth, a healthy gut microbiome, gastrointestinal (GI) tolerance and GI health, and immune development.


Eligibility criteria: Inclusion Criteria:

1. Evidence of personally signed and dated informed consent document indicating that at least one of the infant's parent(s)/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
2. Infants whose parent(s)/LAR(s) have reached the legal age of majority in the countries where the study is conducted.
3. Able to temporarily store stool samples in a household freezer.
4. Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol.
5. Infants whose parent(s)/LAR(s) are able to be contacted directly by telephone throughout the study.
6. Infants must meet all of the following inclusion criteria to be eligible for enrollment into the study:

   1. Healthy term infant (≥37 weeks of gestation).
   2. At enrollment visit, post-natal age ≥14 to ≤35 days / 0.75 - 1 month (date of birth = day 0)
   3. Birth weight ≥ 2500g and ≤ 4500g.
   4. For formula-fed groups, infants must be exclusively consuming and tolerating a cow's milk infant formula at time of enrollment and their parent(s)/LAR(s) must have independently elected, before enrollment, not to breastfeed.
   5. For the breastfed group, infants must have been exclusively consuming breastmilk since birth (small amounts of other feedings allowed during the first three days of life before breastfeeding is well-established), and their parent(s)/LAR(s) must have made the decision to continue exclusively breastfeeding until at least 4 months of age.

Exclusion Criteria:

1. Infants with conditions requiring infant feedings other than those specified in the protocol.
2. Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:

   1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
   2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis).
   3. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study. Of note, children who are normally healthy but at the time of enrolment suffering from acute illness in a minor condition which are common in childhood and do not require some of the exclusionary medication mentioned below can be enrolled.
3. Infants who are presently receiving or have received prior to enrolment any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool microbiota and characteristics (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g., insulin or growth hormone); gastric acid secretion.
4. Currently participating or having participated in another interventional clinical trial since birth.

Primary outcomes:
measure: Safety of experimental formula demonstrated by growth
timeFrame: Baseline Visit 1 to 4 months of age Visit 5
Secondary outcomes:
measure: Efficacy of experimental formula demonstrated by fecal sIgA concentration.
timeFrame: Baseline Visit 1 to 4 months of age Visit 5
measure: Fecal microbiome
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Fecal metabolic profile
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Fecal markers of immune health and gut barrier function
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Fecal cytokine profile
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Blood markers of systemic immunity
timeFrame: Baseline Visit 1 to 4 months of age Visit 5
measure: 3-day GI Symptom and Behavior Diary
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) Index questionnaire
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Weight (g)
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Length (cm)
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Head circumference (cm)
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Respiration
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Heart rate
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Body temperature
timeFrame: Baseline Visit 1 to 6 month of age Visit 6
measure: Physical examination
timeFrame: Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5
measure: Pediatric Immune System Index and Infant Illness Questionnaire
timeFrame: Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5
measure: Antibiotic and antipyretic use
timeFrame: Baseline Visit 1 to 6 month of age Phone visit 7
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Asian Hospital and Medical Center
city: Manila
country: Philippines
facility: University of Perpetual Help DALTA Medical Center
city: Manila
country: Philippines
facility: University of the East Ramon Magsaysay Memorial Medical Center
Study officials:
affiliation: Asian Hospital Medical Center
name: Maria Rosario Capeding, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Perpetual Help Dalta Medical Center
name: Mitzi Trinidad Aseron, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: University of the East Ramon Magsaysay Memorial Medical Center
name: Vinna Marie Quinones, Dr
role: PRINCIPAL_INVESTIGATOR
References: