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

NCT ID: NCT05695300

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-03
• Study Completion Date: 2023-05-31

Brief 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.

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.

Conditions

Infant Development

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

BLM ORGANIC GOLD+

BLM ORGANIC GOLD+ infant formula,800g/can

Group Type: ACTIVE_COMPARATOR

BLM ORGANIC GOLD+

Intervention Type: DIETARY_SUPPLEMENT

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

BLM ORGANIC

BLM ORGANIC infant formula,800g/can

Group Type: PLACEBO_COMPARATOR

BLM ORGANIC

Intervention Type: DIETARY_SUPPLEMENT

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

Breast milk

Mother's breast milk

Group Type: OTHER

Breast milk

Intervention Type: DIETARY_SUPPLEMENT

Participants in this arm need to be fed with breast milk daily for three months, no infant formula

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Breast milk

Participants in this arm need to be fed with breast milk daily for three months, no infant formula

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 30 Days
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bellamy's Organic Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaoyang Sheng, MD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Qiu Bin Community Hospital

Jinhua, Zhejiang, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 22237870 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24215626 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26372517 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16721394 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22196482 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18552710 (View on PubMed)

Other Identifiers

22-SM-10-BLM-001

Identifier Type: -

Identifier Source: org_study_id