Starter Infant Formula With Synbiotics

Healthy Infants Clinical Trial

Official title:

Safety and Efficacy of a Starter Infant Formula With Synbiotics: a Double-blind, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073652
• Other study ID #: 21.14.INF
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Société des Produits Nestlé (SPN)
• Contact: Gemmie Low
• Phone: 97815209
• Email: gemmie.low[@]rd.nestle.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Days to 35 Days

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Infants

Intervention

Other:
• Control 1st age starter infant formula
A standard bovine milk-based term infant formula.
• Experimental 1st age starter infant formula
Same content as Control formula plus supplemented with a HMO blend and a probiotic

Locations

Country	Name	City	State
Philippines	Asian Hospital and Medical Center	Manila
Philippines	University of Perpetual Help DALTA Medical Center	Manila
Philippines	University of the East Ramon Magsaysay Memorial Medical Center	Manila

Sponsors (2)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)	Iqvia Pty Ltd

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of experimental formula demonstrated by growth	Weight gain comparison between infants from experimental and control group	Baseline Visit 1 to 4 months of age Visit 5
Secondary	Efficacy of experimental formula demonstrated by fecal sIgA concentration.	Concentration of sIgA in fecal samples	Baseline Visit 1 to 4 months of age Visit 5
Secondary	Fecal microbiome	Fecal microbiota modulating effect	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Fecal metabolic profile	Fecal pH, fecal organic acids measurement from fecal samples	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Fecal markers of immune health and gut barrier function	Fecal markers of immune health and gut barrier, such as but not restricted to calprotectin and a-1-antitrypsin assessed by ELISA.	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Fecal cytokine profile	Fecal cytokine profile (such as but not restricted to: IL-6, IL-8, IL-1b, IL-22, IFN-?) using multiplex assays.	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Blood markers of systemic immunity	Immunotyping and plasma immune proteomics and Vaccine specific antibodies measurement from blood samples	Baseline Visit 1 to 4 months of age Visit 5
Secondary	3-day GI Symptom and Behavior Diary	GI tolerance, GI symptoms and GI-related behaviors	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Infant Gastrointestinal Symptom Questionnaire (IGSQ-13) Index questionnaire	GI tolerance, GI symptoms and GI-related behaviors	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Weight (g)	Anthropometric measurement. Weight and height will be combined to report BMI in kg/m^2	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Length (cm)	Anthropometric measurement. Weight and height will be combined to report BMI in kg/m^2	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Head circumference (cm)	Anthropometric measurement	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Respiration	Vital signs	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Heart rate	Vital signs	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Body temperature	Vital signs	Baseline Visit 1 to 6 month of age Visit 6
Secondary	Physical examination	Infant illness and infection outcomes	Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5
Secondary	Pediatric Immune System Index and Infant Illness Questionnaire	Infant illness and infection outcomes	Baseline Visit 1 to 3 years of age Observational Follow Up Visit 5
Secondary	Antibiotic and antipyretic use	Concomitant medication reporting	Baseline Visit 1 to 6 month of age Phone visit 7