Sialic AcidNCT05297006
Regulation and Mechanism of New Compound Functional Ingredients in Infants
An observational study of Sialic Acid and Oligosaccharide, run by Peking University Third Hospital at 3 sites in China.
Trial summary
A prospective, multicentre, randomized, double-blind, parallel control study was conducted to analyze the changes in growth, intestinal flora, and immune function of infants with different feeding patterns from postnatal to 1 year of age. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sialic Acid, Oligosaccharide
- What is being tested?
- The infants who drank milk powder were given a dietary intervention four months before
- How many people
- 180 participants
- Where
- 3 sitesChina
- Study dates
- 1 Apr 2022to 31 Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Breastfeeding group The mother can breastfeed exclusively until the infants is at least 4 months old, after which complementary foods are added scientifically according to the baby's condition. Formula group containing new compound functional ingredients Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition. Formula group containing new compound functional ingredients Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.
Who may be able to join
- Healthy infants;
- Full-term (gestational age ≥37 weeks);
- Birth weight 2500-4500g;
- Mothers have no history of diabetes, hypertension, heart disease, and other diseases during pregnancy;
- The guardian signed informed consent and voluntarily enrolled into the group and promised to complete systematic follow-up.
Who cannot join
- Hospitalization with cognitive impairment or deformity ≥2 days
- History of birth asphyxia (Apgar score < 3)
- Severe allergy to milk and serious medical conditions such as intracranial hemorrhage, chronic diarrhea, necrotizing colitis, or acute infection
- The guardian refused to enroll or could not complete the system follow-up.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100191
Jiong Qin, Dr., 13701086050, qinjiong@263.net
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yan Xing, Dr., 13641349699, xingyan770424@vip.sina.com
Peking University First Hospital
Beijing, 100191
Ying Han, Dr., +86 13661013288, hanying1568@126.com
About this study
Official title: Regulation and Mechanism of New Compound Functional Ingredients on Intestinal Microecology and Immune Function in Infants
A prospective, multicentre, randomized, double-blind, parallel control study was conducted to analyze the changes in growth, intestinal flora, and immune function of infants with different feeding patterns from postnatal to 1 year of age.
Read the detailed description
Breast milk is the most beneficial and safe natural food for the growth and development of infants, but some mothers cannot complete breast feeding.For infants who cannot be breastfed, how to improve the composition of formula milk powder and improve the growth and development of infants is an important issue to be solved urgently in this field.It has been found that new compound functional ingredients oligosaccharides and sialic acid may be beneficial to the healthy growth and development of infants and young children, but the specific mechanism and significance are still unclear due to the lack of systematic research.Known as the "second Brain", the gut is connected to the Brain via the brain-gut-axis.Intestinal microecological status can significantly affect the development of infant nervous system and immune system, and then affect the occurrence of related diseases in adulthood.Oligosaccharides and sialic acid may affect the structure of intestinal microecology, protect the immune function of infants and promote the healthy development of infants.This project is based on the previous studies, using multicenter, prospective, randomized, double-blind, parallel-group trial, discussion of oligosaccharides and sialic acid in infants and young children the intestinal micro ecology and the regulation of immune function and the role mechanism, revealing the oligosaccharides and sialic acid in infants and young children the role of immediate and long-term growth, and the significance of these new type of composite function is added to the dairy ingredients, to research and development more accord with our country new dairy products provide theoretical basis for the healthy growth of infants and young children.
- Conditions
- Sialic Acid, Oligosaccharide
- Being tested
- The infants who drank milk powder were given a dietary intervention four months before
- Keywords
- Infant, Human milk, Growth and development, immune level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The infants who drank milk powder were given a dietary intervention four months beforeDietary supplement
The infants who eat milk powder were randomly divided into two groups: group containing new compound functional ingredients and group without new compound functional ingredients
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding group | The mother can breastfeed exclusively until the infants is at least 4 months old, after which complementary foods are added scientifically according to the baby's condition. | |
| Formula group containing new compound functional ingredients | Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition. Receives: Dietary Supplement: The infants who drank milk powder were given a dietary intervention four months before | |
| Formula group without new compound functional ingredients | Only use formula milk powder without oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition. Receives: Dietary Supplement: The infants who drank milk powder were given a dietary intervention four months before |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth and development indexes
Baby body length, weight, head circumference gain
Measured: 12 months
Growth and development indexes
Baby body weight gain
Measured: 12 months
Growth and development indexes
Baby body head circumference gain
Measured: 12 months
Neurodevelopmental level
The Peabody scale was used to assess the level of neural development of infants at 4 months and 6 months
Measured: 4 months
Neurodevelopmental level
The Peabody scale was used to assess the level of neural development of infants at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sialic AcidStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297006
- Sponsor's protocol ID
- S170003
- Status last verified
- Mar 2022
- First submitted
- 6 Dec 2020
- Last updated
- 25 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation and Mechanism of New Compound Functional Ingredients on Intestinal Microecology and Immune Function in Infants
- ClinicalTrials.gov ID
- NCT05297006
- Acronym / sponsor ID
- S170003
- Conditions
- Sialic Acid, Oligosaccharide
- Keywords
- Infant, Human milk, Growth and development, immune level
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Mar 2022 (actual)
- 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.
A prospective, multicentre, randomized, double-blind, parallel control study was conducted to analyze the changes in growth, intestinal flora, and immune function of infants with different feeding patterns from postnatal to 1 year of age.
Detailed description
Breast milk is the most beneficial and safe natural food for the growth and development of infants, but some mothers cannot complete breast feeding.For infants who cannot be breastfed, how to improve the composition of formula milk powder and improve the growth and development of infants is an important issue to be solved urgently in this field.It has been found that new compound functional ingredients oligosaccharides and sialic acid may be beneficial to the healthy growth and development of infants and young children, but the specific mechanism and significance are still unclear due to the lack of systematic research.Known as the "second Brain", the gut is connected to the Brain via the brain-gut-axis.Intestinal microecological status can significantly affect the development of infant nervous system and immune system, and then affect the occurrence of related diseases in adulthood.Oligosaccharides and sialic acid may affect the structure of intestinal microecology, protect the immune function of infants and promote the healthy development of infants.This project is based on the previous studies, using multicenter, prospective, randomized, double-blind, parallel-group trial, discussion of oligosaccharides and sialic acid in infants and young children the intestinal micro ecology and the regulation of immune function and the role mechanism, revealing the oligosaccharides and sialic acid in infants and young children the role of immediate and long-term growth, and the significance of these new type of composite function is added to the dairy ingredients, to research and development more accord with our country new dairy products provide theoretical basis for the healthy growth of infants and young children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding group | – | –The mother can breastfeed exclusively until the infants is at least 4 months old, after which complementary foods are added scientifically according to the baby's condition. |
| Formula group containing new compound functional ingredients | – | Dietary Supplement: The infants who drank milk powder were given a dietary intervention four months beforeOnly use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition. |
| Formula group without new compound functional ingredients | – | Dietary Supplement: The infants who drank milk powder were given a dietary intervention four months beforeOnly use formula milk powder without oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Breastfeeding group The mother can breastfeed exclusively until the infants is at least 4 months old, after which complementary foods are added scientifically according to the baby's condition. Formula group containing new compound functional ingredients Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition. Formula group containing new compound functional ingredients Only use formula milk powder containing oligosaccharides, sialic acid and other ingredients feed the infants for at least 4 months, and then complementary food is added scientifically according to the infant's condition.
Key inclusion criteria (5 listed)
- Healthy infants;
- Full-term (gestational age ≥37 weeks);
- Birth weight 2500-4500g;
- Mothers have no history of diabetes, hypertension, heart disease, and other diseases during pregnancy;
- The guardian signed informed consent and voluntarily enrolled into the group and promised to complete systematic follow-up.
Key exclusion criteria (4 listed)
- Hospitalization with cognitive impairment or deformity ≥2 days
- History of birth asphyxia (Apgar score < 3)
- Severe allergy to milk and serious medical conditions such as intracranial hemorrhage, chronic diarrhea, necrotizing colitis, or acute infection
- The guardian refused to enroll or could not complete the system 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 |
|---|---|---|
| The infants who drank milk powder were given a dietary intervention four months beforeThe infants who eat milk powder were randomly divided into two groups: group containing new compound functional ingredients and group without new compound functional ingredients | Dietary supplement | Formula group containing new compound functional ingredients, Formula group without new compound functional ingredients |
Primary outcome
Growth and development indexes
Time frame: 12 months
Baby body length, weight, head circumference gain
Growth and development indexes
Time frame: 12 months
Baby body weight gain
Growth and development indexes
Time frame: 12 months
Baby body head circumference gain
Neurodevelopmental level
Time frame: 4 months
The Peabody scale was used to assess the level of neural development of infants at 4 months and 6 months
Neurodevelopmental level
Time frame: 6 months
The Peabody scale was used to assess the level of neural development of infants at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sialic Acid and Oligosaccharide, run by Peking University Third Hospital at 3 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 5 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 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Ying T Han (+8613661013288, hanying1568@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth and development indexes (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2022.