Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein

NCT04880083 | Completed

• 1 other identifier: 20.15.INF
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized, single-arm, open-label, prospective interventional study using a commercially available starter infant formula in healthy term formula-fed infants with a parallel group of healthy term breast-fed infants as reference group. Approximately 120 male and female infants (60 per group) who are 3-28 days old and are exclusively or predominately formula-feeding or breastfeeding will be enrolled.

Conditions

Digestion; Gut Microbiota

Keywords

gut tolerance; gut microbiota; gut immunity

Outcome Measures

Primary Outcomes (1)

• Overall gastrointestinal (GI) tolerance

  Compare the overall gastrointestinal (GI) tolerance between the formula-fed and the breast-fed infants from enrolment to 6 weeks of intervention. Assessed through the IGSQ-13 (Infant Gastrointestinal Symptoms Questionnaire). The IGSQ-13, consisting of 13 questions, is a retrospective, standardized, validated, questionnaire of GI symptoms and related behaviors that the infant experienced over the past week from a parent's perspective. Overall GI tolerance is assessed from the IGSQ index score, computed from the 13 questions. Possible scores range from 13 - 65, with lower scores representing lower overall GI burden.

  Day 39-45

Secondary Outcomes (24)

• Change in Bifidobacteria abundance

  Day 1, Day 36-44

• Fecal microbiota

  Day 1, Day 36-44

• Fecal metabolism

  Day 1, Day 36-44

• GI immunity assessed from fecal markers

  Day 1, Day 36-44

• GI maturation assessed from fecal markers

  Day 1, Day 36-44

Study Arms (2)

Formula-Fed (FF) Group

EXPERIMENTAL

Subjects will be fed commercial bovine milk-based, whey-predominant, α-lactalbumin-enriched term formula with high sn-2 palmitate fat blend, supplemented with oligofructose for 6 weeks.

Dietary Supplement: Commercially Available Starter Infant Formula

Breast-Fed (BF) Group

NO INTERVENTION

Subjects will continue exclusive/ predominant breastfeeding for 6 weeks. Breastmilk may be consumed directly from the breast or breast milk may be expressed and fed through infant feeding bottle.

Interventions

Commercially Available Starter Infant Formula DIETARY_SUPPLEMENT

Study formula is provided in powder form and will be administered orally, ad libitum, via an infant feeding bottle and the volume of formula offered to the infant will be guided by the recommended feeding table for the age group or by physician recommendation. The amount consumed by the infant will vary by each infant's weight and appetite.

Formula-Fed (FF) Group

Eligibility Criteria

• Age: 3 Days - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 study.
• Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
• Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
• Infants whose parent(s)/LAR can be contacted directly by telephone throughout the study.
• Infants whose parent(s)/LAR have a working freezer.
• Healthy term infant (37-42 weeks of gestation).
• At enrolment visit, post-natal age 3-28 days (date of birth = day 0)
• Birth weight ≥ 2500g and ≤ 4500g.
• Formula-fed infants only: Infants must predominantly consume and tolerate a standard cow's milk infant formula prior to enrolment and their parent(s)/LAR must have independently elected, before enrolment, not to exclusively breastfeed. Predominantly formula feeding means that the infant's predominant source of nourishment has been formula. Specifically, infants are fed with formula for at least 75% of total milk feeds per day.
• Breastfed infants only: Infants must have been predominantly breastfed since birth, and their parent(s)/LAR must have made the decision to continue predominant breastfeeding for the duration of the study. Predominant breastfeeding allows infants to be mix fed with breastmilk and other milks. It means that the infant's predominant source of nourishment has been breastmilk. Specifically, infants are fed with breast milk for at least 75% of total milk feeds per day.

You may not qualify if:

• 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 enrollment.
• Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:
• Evidence of major congenital malformations (e.g., cleft palate, extremity malformation).
• Documented 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 study.
• Infants who are presently receiving or have received prior to enrollment 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, glycerin 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.
• Subjects or subjects' parent(s) or legal representative who are not willing and not able to comply with scheduled visits and the requirements of the study protocol.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Medrio, Inc: collaborator
• SAS Institute: collaborator
• Veeva Systems: collaborator

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, China

Location

Study Officials

• Ying Wang

  Shanghai Institute for Pediatric Research at Xinhua Hospital, Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: May 10, 2021
• Study Start: July 9, 2021
• Primary Completion: December 28, 2022
• Study Completion: December 28, 2022
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

CN (1)