NCT05695300

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

February 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

January 5, 2023

Last Update Submit

April 11, 2023

Conditions

Infant Development

Keywords

infant formulagut healthfeces

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change rate of baby length

    baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

  • Change rate of baby head circumference

    baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

  • Change rate of baby weight

    baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

  • Average daily intake of formula

    baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

  • Frequency of adverse events

    baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90

Study Arms (3)

BLM ORGANIC GOLD+

ACTIVE COMPARATOR

BLM ORGANIC GOLD+ infant formula,800g/can

Dietary Supplement: BLM ORGANIC GOLD+

BLM ORGANIC

PLACEBO COMPARATOR

BLM ORGANIC infant formula,800g/can

Dietary Supplement: BLM ORGANIC

Breast milk

OTHER

Mother's breast milk

Dietary Supplement: Breast milk

Interventions

BLM ORGANIC GOLD+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 GOLD+
BLM ORGANICDIETARY_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
Breast milkDIETARY_SUPPLEMENT

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

Breast milk

Eligibility Criteria

Age30 Days - 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qiu Bin Community Hospital

Jinhua, Zhejiang, China

Location

Related 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.

    PMID: 22237870BACKGROUND

  • 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.

    PMID: 24215626BACKGROUND

  • 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.

    PMID: 26372517BACKGROUND

  • 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.

    PMID: 16721394BACKGROUND

  • 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.

    PMID: 22196482BACKGROUND

  • 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.

    PMID: 18552710BACKGROUND

MeSH Terms

Interventions

Milk, Human

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Xiaoyang Sheng, MD

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 25, 2023

Study Start

February 3, 2023

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)