DigestionNCT04880083
Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein
A study testing Commercially Available Starter Infant Formula in people with Digestion and Gut Microbiota, run by Société des Produits Nestlé (SPN) at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Digestion, Gut Microbiota
- What is being tested?
- Commercially Available Starter Infant Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2021to 28 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- Infants must meet all the following inclusion criteria to be eligible for enrolment into the study:
Show all 11Show fewer
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein: A Single-arm, Open-label, Prospective Interventional Study Including a Breastfed Reference Group
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.
Read the detailed description
Breastmilk contains an abundance of structurally diverse compounds having important physiologic roles. These include glycoproteins which are biologically active and involved in infant gut, immune and brain development (Jiang and Lönnerdal 2016).
The overall purpose of this study is to study the effectiveness of a term infant formula rich in glycoprotein (formula-fed group) on gastrointestinal tolerance, and gastrointestinal health in healthy term infants compared to a breast-fed reference group. We hypothesize that there will be comparable gastrointestinal tolerance in formula-fed and breast-fed and that fecal bifidobacteria changes in early infancy in the formula-fed group are similar to that of breast-fed infants.
- Conditions
- Digestion, Gut Microbiota
- Being tested
- Commercially Available Starter Infant Formula
- Keywords
- gut tolerance, gut microbiota, gut immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially Available Starter Infant FormulaDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 39-45
Secondary outcomes (24)
Change in Bifidobacteria abundance
Change in Bifidobacteria abundance from baseline to be measured in the stool samples collected.
Measured: Day 1, Day 36-44
Fecal microbiota
Overall fecal microbiota composition and diversity and community type. Diversity will include relative abundance of beneficial and pathogenic bacteria species (such as beneficial bifidobacteria diversity). To be measured in stool samples collected.
Measured: Day 1, Day 36-44
Fecal metabolism
To be measured in stool samples collected. The metabolic profile consist of pH and organic acids (such as but not restricted to acetate, lactate, butyrate, and propionate), analyzed using HPLC.
Measured: Day 1, Day 36-44
GI immunity assessed from fecal markers
To be measured in stool samples collected. Fecal markers include fecal secretory IgA measured by ELISA. Cytokine profile (such as, but not restricted to: IL-1ra, IL1-alpha, IL-1beta, IL-6, IFN-gamma, and TNF-alpha) measured by multiplex assays. OPV-specific IgA measured by ELISA.
Measured: Day 1, Day 36-44
GI maturation assessed from fecal markers
To be measured in stool samples collected. Includes fecal markers of GI health and maturation assessed by ELISA, such as but not restricted to α-1-antitrypsin and lipocalin.
Measured: Day 1, Day 36-44
Stool characteristics: Stool frequency
Stool frequency using the 1-day and 3-day Stooling and Milk Intake Diary.
Measured: Day 0, Day 36-44
Stool characteristics: Difficulty in passing stool
Difficulty in passing stool using the 1-day and 3-day Stooling and Milk Intake Diary.
Measured: Day 0, Day 36-44
Stool characteristics: Stool consistency
Stool consistency using a 5-point scale in the 1-day and 3-day Stooling and Milk Intake Diary.
Measured: Day 0, Day 36-44
GI-related behaviors: Stooling
Baby bowel movements using the individual IGSQ (Infant Gastrointestinal Symptoms Questionnaire) questions.
Measured: Day 0, Day 39-45
GI-related behaviors: Incidence of spitting-up
Incidence of spitting-up using the individual IGSQ (Infant Gastrointestinal Symptoms Questionnaire) questions.
Measured: Day 0, Day 39-45
GI-related behaviors: Crying time
Baby crying time using the individual IGSQ (Infant Gastrointestinal Symptoms Questionnaire) questions.
Measured: Day 0, Day 39-45
GI-related behaviors: Fussiness
Baby fussiness using the individual IGSQ (Infant Gastrointestinal Symptoms Questionnaire) questions.
Measured: Day 0, Day 39-45
GI-related behaviors: Incidence of flatulence
Flatulence using the individual IGSQ (Infant Gastrointestinal Symptoms Questionnaire) questions.
Measured: Day 0, Day 39-45
Milk intake (Breast-Fed infants)
Total number of feedings using the 1-day and 3-day Stooling and Milk Intake Diary.
Measured: Day 0, Day 36-44
Milk intake (Formula-Fed infants)
Total number of feedings and total quantity of milk consumed for every formula-feeding using the 1-day and 3-day Stooling and Milk Intake Diary.
Measured: Day 0, Day 36-44
Infant quality of life
Assessed from the Infant Quality of Life Questionnaire (IQI). The IQI is a short, age-appropriate, and relevant tool that assesses 8 health-related domains in infants up to 1 year. The domains are sleeping, feeding, breathing, stooling, mood, skin, interaction and other health problems.
Measured: Day 0, Day 39-45
Growth: Weight of the infant
Weight in grams and corresponding weight-for-age Z-score according to the WHO growth standards.
Measured: Day 0, Day 39-45
Growth: Length of the infant
Length in centimeters and corresponding length-for-age Z-score according to the WHO growth standards.
Measured: Day 0, Day 39-45
Growth: Weight-for-length of the infant
Corresponding weight-for-length Z-score according to the WHO growth standards.
Measured: Day 0, Day 39-45
Growth: Head circumference of the infant
Head circumference in centimeters and corresponding head-circumference-for-age Z-score according to the WHO growth standards.
Measured: Day 0, Day 39-45
Growth: Body mass index (BMI) of the infant
Weight and height will be combined to report the BMI (kg/m2) and corresponding BMI-for-age Z-score according to the WHO growth standards.
Measured: Day 0, Day 39-45
Safety assessment: Infant illness
As part of the standard adverse events (AEs) reporting for safety assessment.
Measured: Day 0 through 14 days after Day 39-45
Safety assessment: Infection outcomes
As part of the standard adverse events (AEs) reporting for safety assessment.
Measured: Day 0 through 14 days after Day 39-45
Safety assessment: Medication use
As part of the standard adverse events (AEs) reporting for safety assessment.
Measured: Day 0 through 14 days after Day 39-45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2021
- Study start9 Jul 2021
- Primary completion28 Dec 2022
- Study completion28 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DigestionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medrio, Inc, SAS Institute, Veeva Systems
- Responsible party
- Sponsor
- Investigators
- Ying Wang, Principal investigator, Shanghai Institute for Pediatric Research at Xinhua Hospital, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880083
- Sponsor's protocol ID
- 20.15.INF
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2021
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Liu M, Dogra SK, Vidal K, Godin JP, Darwish N, Wei X, Reymond L, Li Q, Dong J, Vyllioti AT, Bettler J, Kennedy E, Wang K, Zhai Q, O'Regan J, Samuel TM, Cai W. Effects of an infant formula containing a whey protein concentrate on feeding tolerance and markers of intestinal immune defense in Chinese infants. BMC Nutr. 2026 Jun 26. doi: 10.1186/s40795-026-01395-0. Online ahead of print.
PubMed 42363297
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding Tolerance and Gut Maturation of Infants Consuming a Formula Rich in Glycoprotein: A Single-arm, Open-label, Prospective Interventional Study Including a Breastfed Reference Group
- ClinicalTrials.gov ID
- NCT04880083
- Acronym / sponsor ID
- 20.15.INF
- Conditions
- Digestion, Gut Microbiota
- Keywords
- gut tolerance, gut microbiota, gut immunity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Medrio, Inc, SAS Institute, Veeva Systems
- Study start
- 9 Jul 2021 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 10 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breastmilk contains an abundance of structurally diverse compounds having important physiologic roles. These include glycoproteins which are biologically active and involved in infant gut, immune and brain development (Jiang and Lönnerdal 2016).
The overall purpose of this study is to study the effectiveness of a term infant formula rich in glycoprotein (formula-fed group) on gastrointestinal tolerance, and gastrointestinal health in healthy term infants compared to a breast-fed reference group. We hypothesize that there will be comparable gastrointestinal tolerance in formula-fed and breast-fed and that fecal bifidobacteria changes in early infancy in the formula-fed group are similar to that of breast-fed infants.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Formula-Fed (FF) Group | Experimental | Dietary Supplement: Commercially Available Starter Infant FormulaSubjects 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. |
| 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. |
Who may qualify
- Ages
- 3 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercially Available Starter Infant FormulaStudy 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. | Dietary supplement | Formula-Fed (FF) Group |
Primary outcome
Overall gastrointestinal (GI) tolerance
Time frame: Day 39-45
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.
24 secondary outcomes
Change in Bifidobacteria abundance
Time frame: Day 1, Day 36-44
Fecal microbiota
Time frame: Day 1, Day 36-44
Fecal metabolism
Time frame: Day 1, Day 36-44
GI immunity assessed from fecal markers
Time frame: Day 1, Day 36-44
GI maturation assessed from fecal markers
Time frame: Day 1, Day 36-44
Stool characteristics: Stool frequency
Time frame: Day 0, Day 36-44
Stool characteristics: Difficulty in passing stool
Time frame: Day 0, Day 36-44
Stool characteristics: Stool consistency
Time frame: Day 0, Day 36-44
GI-related behaviors: Stooling
Time frame: Day 0, Day 39-45
GI-related behaviors: Incidence of spitting-up
Time frame: Day 0, Day 39-45
GI-related behaviors: Crying time
Time frame: Day 0, Day 39-45
GI-related behaviors: Fussiness
Time frame: Day 0, Day 39-45
GI-related behaviors: Incidence of flatulence
Time frame: Day 0, Day 39-45
Milk intake (Breast-Fed infants)
Time frame: Day 0, Day 36-44
Milk intake (Formula-Fed infants)
Time frame: Day 0, Day 36-44
Infant quality of life
Time frame: Day 0, Day 39-45
Growth: Weight of the infant
Time frame: Day 0, Day 39-45
Growth: Length of the infant
Time frame: Day 0, Day 39-45
Growth: Weight-for-length of the infant
Time frame: Day 0, Day 39-45
Growth: Head circumference of the infant
Time frame: Day 0, Day 39-45
Growth: Body mass index (BMI) of the infant
Time frame: Day 0, Day 39-45
Safety assessment: Infant illness
Time frame: Day 0 through 14 days after Day 39-45
Safety assessment: Infection outcomes
Time frame: Day 0 through 14 days after Day 39-45
Safety assessment: Medication use
Time frame: Day 0 through 14 days after Day 39-45
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Derived from this study: PubMed 42363297Wang Y, Liu M, Dogra SK, Vidal K, Godin JP, Darwish N, Wei X, Reymond L, Li Q, Dong J, Vyllioti AT, Bettler J, Kennedy E, Wang K, Zhai Q, O'Regan J, Samuel TM, Cai W. Effects of an infant formula containing a whey protein concentrate on feeding tolerance and markers of intestinal immune defense in Chinese infants. BMC Nutr. 2026 Jun 26. doi: 10.1186/s40795-026-01395-0. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Wang principal investigator
Shanghai Institute for Pediatric Research at Xinhua Hospital, Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercially Available Starter Infant Formula in people with Digestion and Gut Microbiota, run by Société des Produits Nestlé (SPN) at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall gastrointestinal (GI) tolerance (time frame: Day 39-45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04880083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.