Gut Health,Feces Characteristics and Growth of Infants Fed With a New Infant Organic Formula

April 11, 2023 updated by: Bellamy's Organic Pty Ltd

A Randomized, Double-blind, Controlled Study to Evaluate the Gut Health, Feces Characteristics and Growth of Healthy Term Infants Fed With a New Infant Organic Formula

The goal of this clinical trial is to evauate the gut health, feces characteristics and growth of infants fed with a new study organic formula (investigational formula).

75 eligible infants of 30 days old will be enrolled at one center and randomized to feed the investigational formula, control formula, and breast milk for 3 months.

Researchers will compare the three groups to evaluate the gut health, feces characteristics and growth of infants by the end of the study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a single center, double-blind, randomized, controlled, parallel-designed, prospective trial. Approximately 75 partipants of 30 days old will be enrolled from a study site, 50 of whom will be randomized 1:1 to receive an mask labelled investigational formula or a control formula for 3 months of feeding. The remaining approximately 25 partipants will be enrolled as a breastfeeding reference group. Parents will be instructed to exclusively feed the study formula (formula groups) or exclusively human milk (breastfeeding group) during the study. The study will consist of 4 study visits, on baseline day, and every 30 days. At each visit, all relevant clinical data of partipants will be captured and recorded into CTMS (Clinical Trial Management System). The data will be exported, analyzed and reported upon the study completion.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • 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
    • Zhejiang
      • Jinhua, Zhejiang, China
        • Qiu Bin Community 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

Ages Eligible for Study

1 month to 1 month (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 30 days of age at randomization and enrollment, inclusive (day of birth is considered day 0)
  • Plan to exclusively formula feed (formula groups) OR exclusively feed human milk (breastfeeding group)
  • Singleton birth
  • Gestational age of 37-42 completed weeks (37 weeks 0 days through 42 weeks 6 days)
  • Birth weight of 2490g to 4200g
  • Signed informed consent obtained for infant's and mother's participation in the study

Exclusion Criteria:

  • History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
  • Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion)
  • Infants with a known allergy to cow's milk protein or a well-documented family history of allergy to cow's milk protein
  • Weight at randomization is <90% of birth weight [(weight at Visit 1÷birth weight) x 100 <90%]
  • Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others)
  • Known head/brain disease/injury such as microcephaly, macrocephaly or others.
  • Enrollment in another interventional clinical research study while participating in this study

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BLM ORGANIC GOLD+
BLM ORGANIC GOLD+ infant formula,800g/can
Dietary supplement: BLM ORGANIC GOLD+
Participants in this arm need to be fed the assigned infant formula daily for three months, no other formula or breast milk
Placebo Comparator: BLM ORGANIC
BLM ORGANIC infant formula,800g/can
Dietary supplement: BLM ORGANIC
Participants in this arm need to be fed the assigned infant formula daily for three months,no other formula or breast milk
Other: Breast milk
Mother's breast milk
Dietary supplement: Breast milk
Participants in this arm need to be fed with breast milk daily for three months, no infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in stool consistency, color and amount
Time Frame: over 3 months
Change in stool consistency, color and amount (by Amsterdam Infant Stool Scale, AISS, 2008) from baseline to 3 months
over 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change rate of baby length
Time Frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate in mm/day of baby length for each visit interval
baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate of baby head circumference
Time Frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate in mm/day of baby head circumference for each visit interval
baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate of baby weight
Time Frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Change rate in gram/day of baby weight for each visit interval
baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Average daily intake of formula
Time Frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Average daily intake of formula in gram or ml for each visit interval
baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Frequency of adverse events
Time Frame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Frequency of adverse events for each visit interval
baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

Collaborators and Investigators

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

Sponsor

Bellamy's Organic Pty Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 3, 2023

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 22-SM-10-BLM-001

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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