Efficacy of Two HMOs in Chinese Infants

Nestlé

Status: Not yet enrolling

Conditions: Healthy Infants

Treatments: Other: Experimental Group (EG); Other: Control Group (CG)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06361719

2312INF

Details and patient eligibility

About

This is a randomized, controlled, double-blind, intervention trial of healthy male and female term infants to evaluate the efficacy of the 2 HMOs on beneficially modulating the gut microbiota, gut maturation, gut barrier integrity, immune response, and other developmental outcomes in healthy Chinese infants. The trial consists of 2 randomized formula-fed groups, and a non-randomized breastfed reference group.

Enrollment: 262 estimated patients

Sex: All

Ages: 3 to 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male and female infants of post-natal age of 3-14 days (date of birth = day 0), inclusive, at enrolment
• Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the trial.
• Infants whose parent(s) have reached the legal age of majority in China.
• Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the trial protocol.
• Infants whose parent(s)/LAR can be contacted directly by telephone throughout the trial.
• Infants whose parent(s)/LAR have a working freezer.
• Singleton, healthy, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
• For the formula-fed groups: infant is exclusively consuming and tolerating a cow' s milk infant formula for at least 3 days prior to enrolment. The infant's mother has independently elected not to breastfeed.
• For the breastfed reference group: infant has been exclusively consuming breastmilk since birth and the infant's mother has made the decision to continue exclusively breastfeeding until at least 3 months of age.

Exclusion criteria

• Infants with conditions requiring infant feedings other than those specified in the protocol.
• Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrolment.
• Infants who have a medical condition or history that could increase the risk associated with trial participation or interfere with the interpretation of trial results, including: Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). Documented or suspected systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis). 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 trial.
• Infants who are presently receiving or have received prior to enrolment probiotic supplements or 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 characteristics and microbiota (e.g., oral and systemic antibiotics, glycerine suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
• Currently participating or having participated in another clinical trial since birth.
• Infant who has known or suspected cows' milk protein intolerance / allergy, lactose intolerance, soy intolerance / allergy.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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262 participants in 3 patient groups

Experimental Group (EG)

Experimental group

Description:

Starter infant formula supplemented with two HMOs. Following the intervention period, the infants will consume a standard infant follow-up formula (non-trial formula).

Treatment:

Other: Experimental Group (EG)

Control Group (CG)

Active Comparator group

Description:

Starter infant formula not supplemented with two HMOs. Following the intervention period, the infants will consume a standard infant follow-up formula (non-trial formula).

Treatment:

Other: Control Group (CG)

Breastfed Group (BG)

No Intervention group

Description:

Breast Milk