Efficacy of Two HMOs in Chinese Infants

Healthy Infants Clinical Trial

Official title:

Efficacy of a Ready to Feed (RTF) Starter Liquid Infant Formula Containing 2'FL and LNnT in Chinese Infants: A Double-blind, Randomized Controlled Trial Including a Breastfed Reference Group

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06361719
• Other study ID #: 2312INF
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: June 2027

Study information

• Verified date: April 2024
• Source: Société des Produits Nestlé (SPN)
• Contact: Qiaoji Li
• Phone: 008613910051543
• Email: qiaoji.li[@]rd.nestle.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 262
• Est. completion date: June 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Days to 14 Days

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Infants

Intervention

Other:
• Experimental Group (EG)
Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).
• Control Group (CG)
Starter infant formula will be administered to the participants orally, ad libtium to 6 months, after which they will transfer to a classical follow-up formula (non-trial formula) until the end of the trial (12 months of age).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Formula feeding	Total quantity of milk consumed for formula-feeding	From enrollment until 12 months of age
Other	Breastfeeding	The frequency of breastfeeding, duration and type of breastfeeding (exclusive, predominant, partial)	From enrollment until 12 months of age
Other	Infant dietary pattern	3-day food diary	From 6 months of age until 12 months of age
Primary	Bifidobacteria abundance in fecal samples	Bifidobacteria abundance using qPCR technology	just prior to 3 months of age
Secondary	Gut microbiota composition	Relative abundance of beneficial and potentially pathogenic species using next generation sequencing (NGS) technology	From enrollment until 12 months of age
Secondary	Fecal metabolism	Fecal pH analyzed using HPLC as well as targeted or untargeted metabolomics profiling	From enrollment until 12 months of age
Secondary	Fecal metabolism	Short chain fatty acids analyzed using HPLC as well as targeted or untargeted metabolomics profiling	From enrollment until 12 months of age
Secondary	Fecal markers of intestinal immune health	Fecal secretory IgA measured by ELISA	From enrollment until 6 months of age
Secondary	Fecal markers of gut barrier function	Calprotectin measured by ELISA	From enrollment until 6 months of age
Secondary	Fecal markers of gut barrier function	a-1-antitrypsin measured by ELISA	From enrollment until 6 months of age
Secondary	Fecal markers of gut barrier function	Lipocalin-2 measured by ELISA	From enrollment until 6 months of age
Secondary	Fecal markers of inflammation	Levels of cytokines such as IL-1ß measured by ELISA	From enrollment until 6 months of age
Secondary	Fecal markers of inflammation	Levels of cytokines such as IFN-? measured by ELISA	From enrollment until 6 months of age
Secondary	Fecal markers of inflammation	Levels of cytokines such as TNF-a measured by ELISA	From enrollment until 6 months of age
Secondary	Stool patterns	Stool frequency, consistency, and difficulty in passing stools assessed using a 1-day retrospective stool consistency diary (24-hr recall)	From enrollment until 14 days
Secondary	Stool patterns	Stool frequency, consistency, and difficulty in passing stools assessed using a 3-day prospective collection recorded in the stool consistency diary.	From enrollment until 12 months of age
Secondary	GI symptoms and behaviors	IGSQ-13 Questionnaire	From enrollment until 6 months of age
Secondary	Immune competence	Pediatric Immune System Index score	From enrollment until 12 months of age
Secondary	Infant sleep duration and night-time wakings per 24 hours	Brief infant sleep questionnaire (BISQ)	From enrollment until 6 months of age
Secondary	Infant Health Related Quality of Life	Infant Toddler Quality of Life Questionnaire (ITQoL -SF47)	From enrollment until 6 months of age
Secondary	Growth	Weight (g) and corresponding Z-scores	From enrollment until 12 months of age
Secondary	Growth	Length (cm) and corresponding Z-scores	From enrollment until 12 months of age
Secondary	Growth	Head circumference (cm) and corresponding Z-scores	From enrollment until 12 months of age
Secondary	Growth	Weight gain and corresponding Z-scores	From enrollment until 12 months of age
Secondary	Growth	Length gain, corresponding Z-scores	From enrollment until 12 months of age
Secondary	Physical Examination		At enrollment and at 12 months of age
Secondary	Infant Illness	Infant Illness Diary	From enrollment until 12 months of age
Secondary	Infant illness, infections and medication usage	AEs and Serious Adverse Events (SAEs)	From the time the informed consent form has been signed at enrollment infant age less than 3 days until 12 months of age
Secondary	Medication use (type and duration)	Concomitant medication form and Infant Illness Diary	From enrollment until 12 months of age