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| Name | Class |
|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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The goal of this observational study is to compare the incidence of ARI and/or diarrheal disease associated with feeding different formulas with and without lactoferrin supplement in children of 2-3 years old. 200 children eligible for the study will be enrolled from two study sites and randomly assigned to two groups (a2 growing up stage 3 formula puls lactoferrin supplement, and Enfinitas growing up stage 3 formula) to feed for 90 days. About 160 children (80 for each group) are expected to finish the study, and data will be collected during the four visits across the study.
Researchers will compare the two groups to see if there is significant decrease of the occurrence of diarrheal disease and/or acute respiratory infection for children fed with a2 growing up stage 3 formula puls lactoferrin supplement
This study is two arms, opening parallel-designed, observational study. Diarrheal and infectious episodes, including acute upper and lower respiratory infections (ARI), changes in stool patterns, use of systemic antibiotics, adverse events and study formula consumption will be compared in children 2 - 3 years of age who are assigned to receive one of the two following study formulas for a 3-month feeding period: a2 growing up stage 3 formula puls lactoferrin supplement and Enfinitas growingup stage 3 formula.
200 children eligible for the study will be enrolled from two study sites and randomly assigned to two groups to feed for 90 days. About 160 children (80 for each group) are expected to finish the study, and data of primary and secondary outcomes will be collected during the four visits across the study. A sample size of 80 completed per group is needed to achieve a 80% power.
The Andersen-Gill model will be used to model the primary outcome (recurrent event of either diarrheal disease or an acute respiratory infection) under the framework of the proportional hazard assumption. For other secondary outcomes such as duration of acute respiratory infections(ARI) and/or diarrheal disease, episodes of systemic antibiotic use,amount of study formula consumed,changes in stool pattern and cost of treatment will also be analyzed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a2 growing up stage 3 formula puls lactoferrin supplement | per 100g serving
|
| |
| Enfinitas growing up stage 3 formula | per 100g serving
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a2 growing up stage 3 formula puls lactoferrin supplement | Dietary Supplement | The participants in this group will consume 4-5 scoops (8.5g/scoop) of the assigned formula each time, and 4 times per day |
| Measure | Description | Time Frame |
|---|---|---|
| Change of frequency of acute respiratory infection (ARI) and/or diarrheal disease | Change of frequency of acute respiratory infection (ARI) and/or diarrheal disease from baseline to 3 months | baseline day 0, day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of acute respiratory infections(ARI) and/or diarrheal disease | Number of days with acute respiratory infections(ARI) and/or diarrheal disease for each visit | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 |
| Number of days of antibiotics treated |
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Inclusion Criteria:
Exclusion Criteria:
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Full term born children who are 2-3 years old and consume Milk or milk-based beverage regularly
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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 |
|---|---|---|---|---|---|---|
| Nan Quan Community Hospital | Jinhua | Zhejiang | China | |||
| Qiu Bin Community Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24843061 | Background | Li F, Jin X, Liu B, Zhuang W, Scalabrin D. Follow-up formula consumption in 3- to 4-year-olds and respiratory infections: an RCT. Pediatrics. 2014 Jun;133(6):e1533-40. doi: 10.1542/peds.2013-3598. Epub 2014 May 19. | |
| 19651563 | Background | Leyer GJ, Li S, Mubasher ME, Reifer C, Ouwehand AC. Probiotic effects on cold and influenza-like symptom incidence and duration in children. Pediatrics. 2009 Aug;124(2):e172-9. doi: 10.1542/peds.2008-2666. Epub 2009 Jul 27. |
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| Enfinitas growing up stage 3 formula | Dietary Supplement | The participants in this group will consume 4 scoops (10g/scoop) of the assigned formula each time, and 3 times per day |
|
Number of days of antibiotics treated for each visit interval |
| baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 |
| Amount of study formula consumed | Amount of study formula consumed (in grams) | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 |
| Changes in stool pattern | Average number of bowel movements per week and stool consistency | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 |
| Cost of medical treatment | Cost of medical treatment in RMB yuan for each visit interval | baseline day 0, visit 1 day 30, visit 2 day 60, visit 4 day 90 |
| Jinhua |
| Zhejiang |
| China |
| 7782892 | Background | Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995 Jun;125(6):1401-12. doi: 10.1093/jn/125.6.1401. |
| 11978748 | Background | Boehm G, Lidestri M, Casetta P, Jelinek J, Negretti F, Stahl B, Marini A. Supplementation of a bovine milk formula with an oligosaccharide mixture increases counts of faecal bifidobacteria in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2002 May;86(3):F178-81. doi: 10.1136/fn.86.3.f178. |
| 18292252 | Background | Cheng JB, Wang JQ, Bu DP, Liu GL, Zhang CG, Wei HY, Zhou LY, Wang JZ. Factors affecting the lactoferrin concentration in bovine milk. J Dairy Sci. 2008 Mar;91(3):970-6. doi: 10.3168/jds.2007-0689. |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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