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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06361719
Other study ID # 2312INF
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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