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

Infant Development Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05695300
• Other study ID #: 22-SM-10-BLM-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 3, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2023
• Source: Bellamy's Organic Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Days to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant Development

Intervention

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
• BLM ORGANIC
Participants in this arm need to be fed the assigned infant formula daily for three months,no other formula or breast milk
• Breast milk
Participants in this arm need to be fed with breast milk daily for three months, no infant formula

Locations

Country	Name	City	State
China	Qiu Bin Community Hospital	Jinhua	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Bellamy's Organic Pty Ltd

Country where clinical trial is conducted

China, 

References & Publications (6)

Holscher HD, Czerkies LA, Cekola P, Litov R, Benbow M, Santema S, Alexander DD, Perez V, Sun S, Saavedra JM, Tappenden KA. Bifidobacterium lactis Bb12 enhances intestinal antibody response in formula-fed infants: a randomized, double-blind, controlled trial. JPEN J Parenter Enteral Nutr. 2012 Jan;36(1 Suppl):106S-17S. doi: 10.1177/0148607111430817. — View Citation

Kabeerdoss J, Devi RS, Mary RR, Prabhavathi D, Vidya R, Mechenro J, Mahendri NV, Pugazhendhi S, Ramakrishna BS. Effect of yoghurt containing Bifidobacterium lactis Bb12(R) on faecal excretion of secretory immunoglobulin A and human beta-defensin 2 in healthy adult volunteers. Nutr J. 2011 Dec 23;10:138. doi: 10.1186/1475-2891-10-138. — View Citation

Larsen CN, Nielsen S, Kaestel P, Brockmann E, Bennedsen M, Christensen HR, Eskesen DC, Jacobsen BL, Michaelsen KF. Dose-response study of probiotic bacteria Bifidobacterium animalis subsp lactis BB-12 and Lactobacillus paracasei subsp paracasei CRL-341 in healthy young adults. Eur J Clin Nutr. 2006 Nov;60(11):1284-93. doi: 10.1038/sj.ejcn.1602450. Epub 2006 May 24. — View Citation

Mohan R, Koebnick C, Schildt J, Mueller M, Radke M, Blaut M. Effects of Bifidobacterium lactis Bb12 supplementation on body weight, fecal pH, acetate, lactate, calprotectin, and IgA in preterm infants. Pediatr Res. 2008 Oct;64(4):418-22. doi: 10.1203/PDR.0b013e318181b7fa. — View Citation

Szajewska H, Chmielewska A. Growth of infants fed formula supplemented with Bifidobacterium lactis Bb12 or Lactobacillus GG: a systematic review of randomized controlled trials. BMC Pediatr. 2013 Nov 12;13:185. doi: 10.1186/1471-2431-13-185. — View Citation

Taipale TJ, Pienihakkinen K, Isolauri E, Jokela JT, Soderling EM. Bifidobacterium animalis subsp. lactis BB-12 in reducing the risk of infections in early childhood. Pediatr Res. 2016 Jan;79(1-1):65-9. doi: 10.1038/pr.2015.174. Epub 2015 Sep 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in stool consistency, color and amount	Change in stool consistency, color and amount (by Amsterdam Infant Stool Scale, AISS, 2008) from baseline to 3 months	over 3 months
Secondary	Change rate of baby length	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
Secondary	Change rate of baby head circumference	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
Secondary	Change rate of baby weight	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
Secondary	Average daily intake of formula	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
Secondary	Frequency of adverse events	Frequency of adverse events for each visit interval	baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90