Health BehaviorNCT02658500
Short and Long Term Effect of Early Infant Feeding and Nutritional Status on the Children's Health
A study testing Infant Formula and breast milk in people with Health Behavior, run by Beijing Sanyuan Foods Co Ltd at 4 sites in China.
Trial summary
This study evaluates the early infant feeding in the infant intestinal microecology and the long term health. 300 healthy term newborns were involved into the study on its first stage. Read more about this study
- Who is it for?
- Ages Up to 42 daysHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Infant Formula and breast milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 42 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term newborns (the mean gestational age in weeks > 36.0) with birth weight ≥2500 g appropriate for gestational age
- Apgar scores > 7
- Uncomplicated early course of neonatal period
- Impossibility of breastfeeding (for infants randomized into the bottle-feeding groups)
Who cannot join
- The minimum possibility of breastfeeding (for infants randomized into the bottle-feeding groups)
- The diagnosis of a significant chronic medical condition including: HIV infection; cancer; bone marrow or organ transplantation; blood product administration within the last 3 mo; bleeding disorder; known congenital malformation or genetic disorder
- If the parent or legal guardian were unable to read and/or comprehend Chinese
- If the family moved outside of Beijing during the study period (i.e., would be unavailable for follow-up)
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Beijing Ditan Hospital Capital Mendical University
Beijing, Beijing Municipality, 100015
DONG XUEYAN, 18910005185, dongxueyan1985@126.com
- Recruiting
Tongzhou Matemal & Child Health Hospital of Beijing
Beijing, Beijing Municipality, 101100
LI JUFANG, 18910005178, nmgljf109@163.com
- Recruiting
Central South University
Changsha, Hunan, 410083
WANG JIANWU, 18073109116, jianwu_wang@csu.edu.cn
- Recruiting
Henan University of Science and Technology
Luoyang, Henan, 471023
CHEN SHUXING, 18237961965, chenshuxing1@126.com
About this study
This study evaluates the early infant feeding in the infant intestinal microecology and the long term health. 300 healthy term newborns were involved into the study on its first stage. Depending on the type of feeding the infants were divided into 3 groups with random allocation to one of the formula feeding groups: the group A included 100 infants consuming the formula supplement with superior quality whey protein, the group B -100 infants fed with a standard formula, and the group C -100 infants who were breastfed.
Read the detailed description
Throughout the human lifetime, the intestinal microbiota performs vital functions, such as barrier function, metabolic reactions, trophic effects, and maturation of the host's innate and adaptive immune responses. Therefore, the human health depends on the gut health. It is reported that the human gut microbiota of a healthy adult is highly resilient and very stable over time. And before it reaches maturity, the microbiota must develop itself from birth and establish its mutually beneficial cohabitation with the host. However, the early developments of the microbiota in infants are influenced by many factors, such as prenatal parameters, the influence of the mother and her microbiota, and therapies occurring around the time of birth.
Human milk is the sole source of nutrition for infants during the first weeks to months after birth, and has evolved to provide nutrition and immunological protection in the extra-uterine environment into which the infant is born. But when breastfeeding is not possible, human newborns may circumstantially be fed with infant formulas. The difference of feeding mode has been demonstrated to have a strong influence on early gut colonization particularly on the probiotic bacteria. Studies show that breastfed infants have higher counts of Bifidobacteria and Lactobacillus and lower counts of Bacteroides, Clostridium, coccoides group, Staphylococcus, and Enterobacteriaceae as compared with formula-fed infants.
- Conditions
- Health Behavior
- Being tested
- Infant Formula, breast milk
- Keywords
- early infant feeding, infant intestinal flora, infant health
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaDietary supplement
Also called superior quality infant formula
breast milkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Infant Formula | Experimental | 200 newborns just consume the infant formula from 0-42 days to six months age. Receives: Dietary Supplement: Infant Formula |
| Breast Milk | Other | 100 newborns were just fed with breast milk from after birth to six months age. Receives: Dietary Supplement: breast milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the compositions of the intestinal microbiota of infants fed formula and breast milk by high-throughput sequencing
At the age of 1, 2, 3, 6 months, 2 g fecal samples were collected from diapers after defaecation, immediately put into a sterile plastic containers and stored at -20℃ until they were transported (within 24 hours) to the technology center of Beijing Sanyuan Foods Co. Then, each sample was frozen at -80℃ until further processing. The samples were transported on dry ice.
The analysis methods of fecal samples include high-throughput gene sequencing and quantitative real-time PCR for analysis of Bifidobacterium, Lactobacillus, escherichia coli and Candida fungi etc.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2016 (estimated)
- Study startJan 2014
- Primary completionJun 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Sanyuan Foods Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Capital Institute of Pediatrics, China, Peking University, Beijing Ditan Hospital
- Responsible party
- Sponsor
- Investigators
- CHEN LIJUN, Study director, Beijing Sanyuan Foods Co Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658500
- Sponsor's protocol ID
- D14110000481400
- Status last verified
- Jan 2016
- First submitted
- 14 Jan 2016
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Matamoros S, Gras-Leguen C, Le Vacon F, Potel G, de La Cochetiere MF. Development of intestinal microbiota in infants and its impact on health. Trends Microbiol. 2013 Apr;21(4):167-73. doi: 10.1016/j.tim.2012.12.001. Epub 2013 Jan 14.
PubMed 23332725Rouge C, Goldenberg O, Ferraris L, Berger B, Rochat F, Legrand A, Gobel UB, Vodovar M, Voyer M, Roze JC, Darmaun D, Piloquet H, Butel MJ, de La Cochetiere MF. Investigation of the intestinal microbiota in preterm infants using different methods. Anaerobe. 2010 Aug;16(4):362-70. doi: 10.1016/j.anaerobe.2010.06.002. Epub 2010 Jun 9.
PubMed 20541022Ahrne S, Lonnermark E, Wold AE, Aberg N, Hesselmar B, Saalman R, Strannegard IL, Molin G, Adlerberth I. Lactobacilli in the intestinal microbiota of Swedish infants. Microbes Infect. 2005 Aug-Sep;7(11-12):1256-62. doi: 10.1016/j.micinf.2005.04.011. Epub 2005 Jun 8.
PubMed 16002310Endo A, Pӓrtty A, Kalliomӓki M, Isolauri E, Salminen S. Long-term monitoring of the human intestinal microbiota from the 2nd week to 13 years of age. Anaerobe. 2014 Aug;28:149-56. doi: 10.1016/j.anaerobe.2014.06.006. Epub 2014 Jun 13.
PubMed 24933584Bisgaard H, Li N, Bonnelykke K, Chawes BL, Skov T, Paludan-Muller G, Stokholm J, Smith B, Krogfelt KA. Reduced diversity of the intestinal microbiota during infancy is associated with increased risk of allergic disease at school age. J Allergy Clin Immunol. 2011 Sep;128(3):646-52.e1-5. doi: 10.1016/j.jaci.2011.04.060. Epub 2011 Jul 22.
PubMed 21782228Kapiki A, Costalos C, Oikonomidou C, Triantafyllidou A, Loukatou E, Pertrohilou V. The effect of a fructo-oligosaccharide supplemented formula on gut flora of preterm infants. Early Hum Dev. 2007 May;83(5):335-9. doi: 10.1016/j.earlhumdev.2006.07.003. Epub 2006 Sep 14.
PubMed 16978805Chrzanowska-Liszewska D, Seliga-Siwecka J, Kornacka MK. The effect of Lactobacillus rhamnosus GG supplemented enteral feeding on the microbiotic flora of preterm infants-double blinded randomized control trial. Early Hum Dev. 2012 Jan;88(1):57-60. doi: 10.1016/j.earlhumdev.2011.07.002. Epub 2011 Nov 4.
PubMed 22055271Arboleya S, Ang L, Margolles A, Yiyuan L, Dongya Z, Liang X, Solis G, Fernandez N, de Los Reyes-Gavilan CG, Gueimonde M. Deep 16S rRNA metagenomics and quantitative PCR analyses of the premature infant fecal microbiota. Anaerobe. 2012 Jun;18(3):378-80. doi: 10.1016/j.anaerobe.2012.04.013. Epub 2012 May 8.
PubMed 22579986Schwiertz A, Gruhl B, Lobnitz M, Michel P, Radke M, Blaut M. Development of the intestinal bacterial composition in hospitalized preterm infants in comparison with breast-fed, full-term infants. Pediatr Res. 2003 Sep;54(3):393-9. doi: 10.1203/01.PDR.0000078274.74607.7A. Epub 2003 Jun 4.
PubMed 12788986Fallani M, Young D, Scott J, Norin E, Amarri S, Adam R, Aguilera M, Khanna S, Gil A, Edwards CA, Dore J; Other Members of the INFABIO Team. Intestinal microbiota of 6-week-old infants across Europe: geographic influence beyond delivery mode, breast-feeding, and antibiotics. J Pediatr Gastroenterol Nutr. 2010 Jul;51(1):77-84. doi: 10.1097/MPG.0b013e3181d1b11e.
PubMed 20479681Andersen BL, Farrar WB, Golden-Kreutz DM, Glaser R, Emery CF, Crespin TR, Shapiro CL, Carson WE 3rd. Psychological, behavioral, and immune changes after a psychological intervention: a clinical trial. J Clin Oncol. 2004 Sep 1;22(17):3570-80. doi: 10.1200/JCO.2004.06.030.
PubMed 15337807Meropol SB, Edwards A. Development of the infant intestinal microbiome: A bird's eye view of a complex process. Birth Defects Res C Embryo Today. 2015 Dec;105(4):228-39. doi: 10.1002/bdrc.21114. Epub 2015 Dec 11.
PubMed 26663826Wernimont S, Northington R, Kullen MJ, Yao M, Bettler J. Effect of an alpha-lactalbumin-enriched infant formula supplemented with oligofructose on fecal microbiota, stool characteristics, and hydration status: a randomized, double-blind, controlled trial. Clin Pediatr (Phila). 2015 Apr;54(4):359-70. doi: 10.1177/0009922814553433. Epub 2014 Oct 8.
PubMed 25297064Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
PubMed 37929831Qiao W, Chen J, Zhang M, Wang Y, Yang B, Zhao J, Jiang T, Chen L. A cohort study of vitamins contents in human milk from maternal-infant factors. Front Nutr. 2022 Sep 6;9:993066. doi: 10.3389/fnut.2022.993066. eCollection 2022.
PubMed 36147300
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long Term Effect of Early Infant Feeding and Nutritional Status on the Children's Health
- ClinicalTrials.gov ID
- NCT02658500
- Acronym / sponsor ID
- D14110000481400
- Conditions
- Health Behavior
- Keywords
- early infant feeding, infant intestinal flora, infant health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Sanyuan Foods Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- Capital Institute of Pediatrics, China, Peking University, Beijing Ditan Hospital
- Study start
- Jan 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 20 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the early infant feeding in the infant intestinal microecology and the long term health. 300 healthy term newborns were involved into the study on its first stage. Depending on the type of feeding the infants were divided into 3 groups with random allocation to one of the formula feeding groups: the group A included 100 infants consuming the formula supplement with superior quality whey protein, the group B -100 infants fed with a standard formula, and the group C -100 infants who were breastfed.
Detailed description
Throughout the human lifetime, the intestinal microbiota performs vital functions, such as barrier function, metabolic reactions, trophic effects, and maturation of the host's innate and adaptive immune responses. Therefore, the human health depends on the gut health. It is reported that the human gut microbiota of a healthy adult is highly resilient and very stable over time. And before it reaches maturity, the microbiota must develop itself from birth and establish its mutually beneficial cohabitation with the host. However, the early developments of the microbiota in infants are influenced by many factors, such as prenatal parameters, the influence of the mother and her microbiota, and therapies occurring around the time of birth.
Human milk is the sole source of nutrition for infants during the first weeks to months after birth, and has evolved to provide nutrition and immunological protection in the extra-uterine environment into which the infant is born. But when breastfeeding is not possible, human newborns may circumstantially be fed with infant formulas. The difference of feeding mode has been demonstrated to have a strong influence on early gut colonization particularly on the probiotic bacteria. Studies show that breastfed infants have higher counts of Bifidobacteria and Lactobacillus and lower counts of Bacteroides, Clostridium, coccoides group, Staphylococcus, and Enterobacteriaceae as compared with formula-fed infants.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant Formula | Experimental | Dietary Supplement: Infant Formula200 newborns just consume the infant formula from 0-42 days to six months age. |
| Breast Milk | Other | Dietary Supplement: breast milk100 newborns were just fed with breast milk from after birth to six months age. |
Who may qualify
- Ages
- Up to 42 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy term newborns (the mean gestational age in weeks > 36.0) with birth weight ≥2500 g appropriate for gestational age
- Apgar scores > 7
- Uncomplicated early course of neonatal period
- Impossibility of breastfeeding (for infants randomized into the bottle-feeding groups)
Key exclusion criteria (4 listed)
- The minimum possibility of breastfeeding (for infants randomized into the bottle-feeding groups)
- The diagnosis of a significant chronic medical condition including: HIV infection; cancer; bone marrow or organ transplantation; blood product administration within the last 3 mo; bleeding disorder; known congenital malformation or genetic disorder
- If the parent or legal guardian were unable to read and/or comprehend Chinese
- If the family moved outside of Beijing during the study period (i.e., would be unavailable for follow-up)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant FormulaAlso: superior quality infant formula | Dietary supplement | Infant Formula |
| breast milk | Dietary supplement | Breast Milk |
Primary outcome
Comparison of the compositions of the intestinal microbiota of infants fed formula and breast milk by high-throughput sequencing
Time frame: up to 8 months
At the age of 1, 2, 3, 6 months, 2 g fecal samples were collected from diapers after defaecation, immediately put into a sterile plastic containers and stored at -20℃ until they were transported (within 24 hours) to the technology center of Beijing Sanyuan Foods Co. Then, each sample was frozen at -80℃ until further processing. The samples were transported on dry ice. The analysis methods of fecal samples include high-throughput gene sequencing and quantitative real-time PCR for analysis of Bifidobacterium, Lactobacillus, escherichia coli and Candida fungi etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Background: PubMed 23332725Matamoros S, Gras-Leguen C, Le Vacon F, Potel G, de La Cochetiere MF. Development of intestinal microbiota in infants and its impact on health. Trends Microbiol. 2013 Apr;21(4):167-73. doi: 10.1016/j.tim.2012.12.001. Epub 2013 Jan 14.
- Background: PubMed 20541022Rouge C, Goldenberg O, Ferraris L, Berger B, Rochat F, Legrand A, Gobel UB, Vodovar M, Voyer M, Roze JC, Darmaun D, Piloquet H, Butel MJ, de La Cochetiere MF. Investigation of the intestinal microbiota in preterm infants using different methods. Anaerobe. 2010 Aug;16(4):362-70. doi: 10.1016/j.anaerobe.2010.06.002. Epub 2010 Jun 9.
- Background: PubMed 16002310Ahrne S, Lonnermark E, Wold AE, Aberg N, Hesselmar B, Saalman R, Strannegard IL, Molin G, Adlerberth I. Lactobacilli in the intestinal microbiota of Swedish infants. Microbes Infect. 2005 Aug-Sep;7(11-12):1256-62. doi: 10.1016/j.micinf.2005.04.011. Epub 2005 Jun 8.
- Background: PubMed 24933584Endo A, Pӓrtty A, Kalliomӓki M, Isolauri E, Salminen S. Long-term monitoring of the human intestinal microbiota from the 2nd week to 13 years of age. Anaerobe. 2014 Aug;28:149-56. doi: 10.1016/j.anaerobe.2014.06.006. Epub 2014 Jun 13.
- Background: PubMed 21782228Bisgaard H, Li N, Bonnelykke K, Chawes BL, Skov T, Paludan-Muller G, Stokholm J, Smith B, Krogfelt KA. Reduced diversity of the intestinal microbiota during infancy is associated with increased risk of allergic disease at school age. J Allergy Clin Immunol. 2011 Sep;128(3):646-52.e1-5. doi: 10.1016/j.jaci.2011.04.060. Epub 2011 Jul 22.
- Background: PubMed 16978805Kapiki A, Costalos C, Oikonomidou C, Triantafyllidou A, Loukatou E, Pertrohilou V. The effect of a fructo-oligosaccharide supplemented formula on gut flora of preterm infants. Early Hum Dev. 2007 May;83(5):335-9. doi: 10.1016/j.earlhumdev.2006.07.003. Epub 2006 Sep 14.
- Background: PubMed 22055271Chrzanowska-Liszewska D, Seliga-Siwecka J, Kornacka MK. The effect of Lactobacillus rhamnosus GG supplemented enteral feeding on the microbiotic flora of preterm infants-double blinded randomized control trial. Early Hum Dev. 2012 Jan;88(1):57-60. doi: 10.1016/j.earlhumdev.2011.07.002. Epub 2011 Nov 4.
- Background: PubMed 22579986Arboleya S, Ang L, Margolles A, Yiyuan L, Dongya Z, Liang X, Solis G, Fernandez N, de Los Reyes-Gavilan CG, Gueimonde M. Deep 16S rRNA metagenomics and quantitative PCR analyses of the premature infant fecal microbiota. Anaerobe. 2012 Jun;18(3):378-80. doi: 10.1016/j.anaerobe.2012.04.013. Epub 2012 May 8.
- Background: PubMed 12788986Schwiertz A, Gruhl B, Lobnitz M, Michel P, Radke M, Blaut M. Development of the intestinal bacterial composition in hospitalized preterm infants in comparison with breast-fed, full-term infants. Pediatr Res. 2003 Sep;54(3):393-9. doi: 10.1203/01.PDR.0000078274.74607.7A. Epub 2003 Jun 4.
- Background: PubMed 20479681Fallani M, Young D, Scott J, Norin E, Amarri S, Adam R, Aguilera M, Khanna S, Gil A, Edwards CA, Dore J; Other Members of the INFABIO Team. Intestinal microbiota of 6-week-old infants across Europe: geographic influence beyond delivery mode, breast-feeding, and antibiotics. J Pediatr Gastroenterol Nutr. 2010 Jul;51(1):77-84. doi: 10.1097/MPG.0b013e3181d1b11e.
- Background: PubMed 15337807Andersen BL, Farrar WB, Golden-Kreutz DM, Glaser R, Emery CF, Crespin TR, Shapiro CL, Carson WE 3rd. Psychological, behavioral, and immune changes after a psychological intervention: a clinical trial. J Clin Oncol. 2004 Sep 1;22(17):3570-80. doi: 10.1200/JCO.2004.06.030.
- Background: PubMed 26663826Meropol SB, Edwards A. Development of the infant intestinal microbiome: A bird's eye view of a complex process. Birth Defects Res C Embryo Today. 2015 Dec;105(4):228-39. doi: 10.1002/bdrc.21114. Epub 2015 Dec 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHEN LIJUN study director
Beijing Sanyuan Foods Co Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula and breast milk in people with Health Behavior, run by Beijing Sanyuan Foods Co Ltd at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LI JUFANG (86 010-56306349, nmgljf109@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the compositions of the intestinal microbiota of infants fed formula and breast milk by high-throughput sequencing (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02658500, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016; AzTrials last refreshed its copy on 7 Nov 2026.