The Impact of a Novel Infant Formula on Immunity, Gut Health and Growth

August 25, 2026 updated by: Biostime (Guangzhou) Health Products Limited

Assessing the Impact of a Novel Infant Formula on Immunity, Gut Health and Safety: A Multicenter, Double-blind, Randomized, Controlled Trial

The goal of this multicenter, double-blind, randomized, controlled trial is to assess the safety and efficacy of a new infant formula on healthy term infants from enrollment to the age of 6 months.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
342

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Foshan, China
        • Foshan Maternal and Child Health Hospital
      • Guangzhou, China
        • Guangzhou Women and Children's Medical Center
      • Shenzhen, China
        • Shenzhen Hospital of Southern Medical University
      • Shenzhen, China
        • Shenzhen Integrated Traditional Chinese and Western Medicine Hospital
      • Zhongshan, China
        • Zhongshan Boai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. At enrollment visit, post-natal age ≤ 42 days (date of birth = day 0).
  2. Healthy term infant (≥ 37 weeks of gestation).
  3. Infants birth weight ≥ 2500 and ≤ 4500 g.
  4. For formula fed group: infant is mainly consuming IF (more than 75% of the infant diet) until at least 4 months of age. The parents / LAR(s) have independently decided NOT to breastfeed.
  5. For the breastfed reference group: infant has been mainly consuming breastmilk since birth (more than 75% of the infant diet), and the parents / LAR(s) have made the decision to continue breastfeeding until at least 4 months of age.
  6. Evidence of personally signed and dated informed consent indicating that the infant's both parents/LAR(s), as per local regulation, have been informed of all pertinent aspects of the study.
  7. Parents/LAR(s) of infants demonstrate willingness and capability to adhere to scheduled visits, fulfill the study protocol requirements, and remain accessible by phone throughout the study duration.

Exclusion Criteria:

  1. Conditions requiring infant feedings other than those specified in the protocol.

  2. Medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including:

    1. Evidence of major congenital malformation (e.g., cleft palate, extremity malformation)
    2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
    3. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigators, would make the infants inappropriate for entry into the study. Of note, infants who are generally healthy but experiencing minor acute illnesses at the time of enrollment, which are common in infancy and do not necessitate any of the exclusionary medications mentioned below, may still be eligible for enrollment.

  3. Presently receiving or having received prior to enrolment any medication(s) or supplement(s) which are known or suspected to affect the following:

    1. Fat digestion, absorption, and/or metabolism (e.g. pancreatic enzymes);
    2. Stools characteristics and gut microbiota (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose);
    3. Growth (e.g., insulin or growth hormone);
    4. Gastric acid secretion.
  4. Currently participating or having participated in another interventional clinical trial since birth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test
Novel infant formula
Other: Novel infant formula
Infants are fed with the novel infant formula from the date of enrollment to the age of 6 months.
Active Comparator: Control
Standard infant formula
Other: Standard infant formula
Infants are fed with the standard infant formula from the date of enrollment to the age of 6 months.
No Intervention: Reference
Breastfeeding

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Daily body weight gain between V1 and V3
Time Frame: From baseline to the age of 6 months
From baseline to the age of 6 months
Fecal total pathogens load
Time Frame: From baseline to the age of 6 months
From baseline to the age of 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Secretory IgA, calprotectin and antitrypsin A1 in feces at V1, V2 and V3
Time Frame: From baseline to the age of 3 months and the age of 6 months
From baseline to the age of 3 months and the age of 6 months
sIgA in saliva at V1, V2 and V3
Time Frame: From baseline to the age of 3 months and the age of 6 months
From baseline to the age of 3 months and the age of 6 months
Incidence of allergic disease reported by caregivers
Time Frame: From baseline to the age of 3 months and the age of 6 months
From baseline to the age of 3 months and the age of 6 months
Incidence of infectious disease reported by caregivers
Time Frame: from baseline to the age of 3 months and the age of 6 months
from baseline to the age of 3 months and the age of 6 months
Incidence of medications use reported by caregivers
Time Frame: From baseline to the age of 3 months and the age of 6 months
From baseline to the age of 3 months and the age of 6 months
Additional anthropometric measures (body length and head circumference)
Time Frame: From baseline to the age of 3 months and the age of 6 months
From baseline to the age of 3 months and the age of 6 months
GI symptoms and GI-related behaviors assessed via Infant Gastrointestinal Symptom Questionnaire (IGSQ)
Time Frame: From baseline to the age of 3 months and the age of 6 months
From baseline to the age of 3 months and the age of 6 months
Stooling patterns assessed via Amsterdam Infant Stool Scale (AISS)
Time Frame: From baseline to the age of 3 months and the age of 6 months
From baseline to the age of 3 months and the age of 6 months
Overall composition of the fecal microbiota
Time Frame: From baseline to the age of 3 months and the age of 6 months
From baseline to the age of 3 months and the age of 6 months
Fecal metabolome profiles
Time Frame: From baseline to the age of 3 months and the age of 6 months
From baseline to the age of 3 months and the age of 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
The breast milk composition
Time Frame: At baseline only
At baseline only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biostime (Guangzhou) Health Products Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
BioFortis
Merieux NutriSciences (China)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 13, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 17, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 17, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pistar2RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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