Clinical trial NCT06686433: The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth
Official title: Assessing the Impact of a Novel Infant Formula on Immunity, Gut Health and Safety: A Multicenter, Double-blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Term Infant
Lead sponsor: Biostime (Guangzhou) Health Products Limited
Sponsor class: INDUSTRY
Collaborators: name: Merieux NutriSciences (China)
name: BioFortis
First posted: 2024-11-13
Enrollment: 342
Sex: ALL
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.


Eligibility criteria: Inclusion Criteria:

1. At enrollment visit, post-natal age ≤ 42 days (date of birth = day 0).
2. Healthy term infant (≥ 37 weeks of gestation).
3. Infants birth weight ≥ 2500 and ≤ 4500 g.
4. For formula fed group: infant is mainly consuming IF (more than 75% of the infant diet) until at least 4 months of age. The parents / LAR(s) have independently decided NOT to breastfeed.
5. For the breastfed reference group: infant has been mainly consuming breastmilk since birth (more than 75% of the infant diet), and the parents / LAR(s) have made the decision to continue breastfeeding until at least 4 months of age.
6. Evidence of personally signed and dated informed consent indicating that the infant's both parents/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
7. Parents/LAR(s) of infants demonstrate willingness and capability to adhere to scheduled visits, fulfill the study protocol requirements, and remain accessible by phone throughout the study duration.

Exclusion Criteria:

1. Conditions requiring infant feedings other than those specified in the protocol.
2. 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 malformation (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 investigators, would make the infants inappropriate for entry into the study. Of note, infants who are generally healthy but experiencing minor acute illnesses at the time of enrollment, which are common in infancy and do not necessitate any of the exclusionary medications mentioned below, may still be eligible for enrollment.
3. Presently receiving or having received prior to enrolment any medication(s) or supplement(s) which are known or suspected to affect the following:

   1. Fat digestion, absorption, and/or metabolism (e.g. pancreatic enzymes);
   2. Stools characteristics and gut microbiota (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);
   3. Growth (e.g., insulin or growth hormone);
   4. Gastric acid secretion.
4. Currently participating or having participated in another interventional clinical trial since birth.

Primary outcomes:
measure: Daily body weight gain between V1 and V3
timeFrame: From baseline to the age of 6 months
measure: Fecal total pathogens load
timeFrame: From baseline to the age of 6 months
Secondary outcomes:
measure: Secretory IgA, calprotectin and antitrypsin A1 in feces at V1, V2 and V3
timeFrame: From baseline to the age of 3 months and the age of 6 months
measure: sIgA in saliva at V1, V2 and V3
timeFrame: From baseline to the age of 3 months and the age of 6 months
measure: Incidence of allergic disease reported by caregivers
timeFrame: From baseline to the age of 3 months and the age of 6 months
measure: Incidence of infectious disease reported by caregivers
timeFrame: from baseline to the age of 3 months and the age of 6 months
measure: Incidence of medications use reported by caregivers
timeFrame: From baseline to the age of 3 months and the age of 6 months
measure: Additional anthropometric measures (body length and head circumference)
timeFrame: From baseline to the age of 3 months and the age of 6 months
measure: GI symptoms and GI-related behaviors assessed via Infant Gastrointestinal Symptom Questionnaire (IGSQ)
timeFrame: From baseline to the age of 3 months and the age of 6 months
measure: Stooling patterns assessed via Amsterdam Infant Stool Scale (AISS)
timeFrame: From baseline to the age of 3 months and the age of 6 months
measure: Overall composition of the fecal microbiota
timeFrame: From baseline to the age of 3 months and the age of 6 months
measure: Fecal metabolome profiles
timeFrame: From baseline to the age of 3 months and the age of 6 months
Other outcomes:
measure: The breast milk composition
timeFrame: At baseline only
Locations:
city: Shenzhen
country: China
facility: Shenzhen Hospital of Southern Medical University
Study officials:
References: