Clinical trial NCT05695300: Gut Health,Feces Characteristics and Growth of Infants Fed With a New Infant Organic Formula
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Development
Keywords: infant formula
gut health
feces
Lead sponsor: Bellamy's Organic Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in stool consistency, color and amount
timeFrame: over 3 months
Secondary outcomes:
measure: Change rate of baby length
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
measure: Change rate of baby head circumference
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
measure: Change rate of baby weight
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
measure: Average daily intake of formula
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
measure: Frequency of adverse events
timeFrame: baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Qiu Bin Community Hospital
state: Zhejiang
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Xiaoyang Sheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.