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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BLM ORGANIC GOLD+ | Active Comparator | BLM ORGANIC GOLD+ infant formula,800g/can |
|
| BLM ORGANIC | Placebo Comparator | BLM ORGANIC infant formula,800g/can |
|
| Breast milk | Other | Mother's breast milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change rate of baby head circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoyang Sheng, MD | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qiu Bin Community Hospital | Jinhua | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22237870 | Background | 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. | |
| 24215626 |
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| ID | Term |
|---|---|
| D008895 | Milk, Human |
| ID | Term |
|---|---|
| D008892 | Milk |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| BLM ORGANIC | 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 | Dietary Supplement | Participants in this arm need to be fed with breast milk daily for three months, no infant formula |
|
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 | 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 | 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 | Frequency of adverse events for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 |
| 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. |
| 26372517 | Background | 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. |
| 16721394 | Background | 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. |
| 22196482 | Background | 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. |
| 18552710 | Background | 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. |
| D003611 |
| Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |