Efficacy of Two HMOs in Chinese Infants

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-14
SponsorSociété des Produits Nestlé (SPN)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental Group (EG)

    Other intervention

    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)

    Other intervention

    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).

Treatment groups

262 Participants
are divided into 3 treatment groups
Group A: Experimental Group (EG)Experimental treatment 1 intervention
Group B: Control Group (CG)Active comparator 1 intervention
Group C: Breastfed Group (BG)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Bifidobacteria abundance in fecal samples

Bifidobacteria abundance using qPCR technology

Time frame
just prior to 3 months of age

Secondary outcomes

1

Gut microbiota composition

Relative abundance of beneficial and potentially pathogenic species using next generation sequencing (NGS) technology

Time frame
From enrollment until 12 months of age
2

Fecal metabolism

Fecal pH analyzed using HPLC as well as targeted or untargeted metabolomics profiling

Time frame
From enrollment until 12 months of age
3

Fecal metabolism

Short chain fatty acids analyzed using HPLC as well as targeted or untargeted metabolomics profiling

Time frame
From enrollment until 12 months of age
4

Fecal markers of intestinal immune health

Fecal secretory IgA measured by ELISA

Time frame
From enrollment until 6 months of age

Other outcomes

1

Formula feeding

Total quantity of milk consumed for formula-feeding

Time frame
From enrollment until 12 months of age
2

Breastfeeding

The frequency of breastfeeding, duration and type of breastfeeding (exclusive, predominant, partial)

Time frame
From enrollment until 12 months of age
3

Infant dietary pattern

3-day food diary

Time frame
From 6 months of age until 12 months of age

Sponsors and contacts

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