Low Birth Weight InfantsNCT05203900
The Influence by Dietary Human Milk Oligosaccharide in Low Birth Weight Infants
A study testing Infant formula with Human Milk Oligosaccharide and Infant formula without Human Milk Oligosaccharide in people with Low Birth Weight Infants, run by Meiji Co., Ltd. at 1 site in Thailand.
Trial summary
This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO) supplement. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Low Birth Weight Infants
- What is being tested?
- Infant formula with Human Milk Oligosaccharide and Infant formula without Human Milk Oligosaccharide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 13 Dec 2021to 24 May 2023
- 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 1 month
- All sexes
- No healthy volunteers
- Child
- Inclusion Criteria: 1-1) For infants
- Low birth weight infants (defined as a birth weight ≥1,500 g and <2,500 g) during hospitalization and may require milk powder formula as supplement. 1-2) For mothers
- Mothers who do not find serious viral infection ii. Mothers who are willing to provide consent for provision of study required information and specimen(s) from both mothers and infants iii. Mothers who are willing to provide consent as infant's legally acceptable representative (LAR)
- Exclusion Criteria: 2-1) For infants
- Infants who receive any formulas before Informed Consent. ii. Infants with serious infections. iii. Infants with necrotizing enteritis. iv. Infants with gastrointestinal perforation.
- Infants whom the PI determines inappropriate as a study subject (e.g. inflammatory, metabolic abnormalities and difficulty in enteral feeding). 2-2) For mothers
- Mothers the PI determines inappropriate as a study subject ii. Mothers under 18 years old.
- Withdrawal criteria:
A subject must be discontinued from treatment with test formula if any of the following apply:
- If the mother, who is a subject of the study as well as infant's LAR , asks for withdrawal from the study or withdraws consent. ii. When a serious adverse event occurs. iii. When an adverse event occurs, and the PI or co-investigator determines that the study should be discontinued. iv. If it is decided that there is a risk of compromising the safety of the study subject.
- If a subject is found to be ineligible after the start of the study. vi. If it is found that there is a serious or continued non-compliance with the study protocol by a study subject. vii. In addition, if the PI decides to end the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigation of the Influence by Dietary Human Milk Oligosaccharide on Growth Factors and Cytokines in Blood, and Gut Microbiota in Low Birth Weight Infants (a Non-blinded Pilot Clinical Study)
This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO) supplement. Eligible low birth weight infants are allocated to two groups, Investigational formula (with HMO) or Control formula (without HMO). The subjects are taking the assigned formula when they need to be supplemented with formula. After the informed consent was obtained and eligibility was confirmed, the intervention period begins, and ends at the one-month-old medical check-up with the assessment of the various blood growth factors and cytokines, and the gut microbiota.
- Conditions
- Low Birth Weight Infants
- Being tested
- Infant formula with Human Milk Oligosaccharide, Infant formula without Human Milk Oligosaccharide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formula with Human Milk OligosaccharideDietary supplement
Although breastfeeding is encouraged, the shortage is supplemented with the investigational formula. After obtaining the informed consent, the investigational formula is administered to infants under the doctor's direction until a medical check-up at one-month-old.
Infant formula without Human Milk OligosaccharideDietary supplement
Although breastfeeding is encouraged, the shortage is supplemented with the control formula. After obtaining the informed consent, the control formula is administered to infants under the doctor's direction until a medical check-up at one-month-old.
| Study group | Role | What they receive |
|---|---|---|
| Investigational formula | Experimental | Infant formula with Human Milk Oligosaccharide Receives: Dietary Supplement: Infant formula with Human Milk Oligosaccharide |
| Control formula | Placebo comparator | Infant formula without Human Milk Oligosaccharide Receives: Dietary Supplement: Infant formula without Human Milk Oligosaccharide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth factors concentration in infant's plasma
The concentration of NGF-beta (pg/mL), BDNF (pg/mL), etc. in infant's plasma will be measured by immunoassay.
Measured: At one-month-old
Cytokines concentration in infant's plasma
The concentration of IFN-gamma (pg/mL), IL-1alpha (pg/mL), etc. in infant's plasma will be measured by immunoassay.
Measured: At one-month-old
Infant's gut microbiota occupancy
Total bacterial counts and bifidobacterial counts in stool will be measured by RT-PCR (copy/g wet feces). Occupancy of microbiota in infant's stool will be comprehensively analyzed by DNA/RNA Sequencing (percent).
Measured: At one-month-old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start13 Dec 2021
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Birth Weight InfantsStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The number of anticipated participants is 60 mother-infant pairs. The 30 first enrolled mother-infant pairs are assigned to the investigational formula group, and the next 30 enrolled mother-infant pairs are assigned to the control formula group.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203900
- Sponsor's protocol ID
- 2020-003
- Status last verified
- Feb 2023
- First submitted
- 23 Dec 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation of the Influence by Dietary Human Milk Oligosaccharide on Growth Factors and Cytokines in Blood, and Gut Microbiota in Low Birth Weight Infants (a Non-blinded Pilot Clinical Study)
- ClinicalTrials.gov ID
- NCT05203900
- Acronym / sponsor ID
- 2020-003
- Conditions
- Low Birth Weight Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Meiji Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 24 Jan 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.
This study aims to investigate the concentration of various growth factors and cytokines in blood, and to examine the gut microbiota of low birth weight infants fed with formulas with or without Human Milk Oligosaccharide (HMO) supplement. Eligible low birth weight infants are allocated to two groups, Investigational formula (with HMO) or Control formula (without HMO). The subjects are taking the assigned formula when they need to be supplemented with formula. After the informed consent was obtained and eligibility was confirmed, the intervention period begins, and ends at the one-month-old medical check-up with the assessment of the various blood growth factors and cytokines, and the gut microbiota.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The number of anticipated participants is 60 mother-infant pairs. The 30 first enrolled mother-infant pairs are assigned to the investigational formula group, and the next 30 enrolled mother-infant pairs are assigned to the control formula group.
| Arm | Type | Receives |
|---|---|---|
| Investigational formula | Experimental | Dietary Supplement: Infant formula with Human Milk OligosaccharideInfant formula with Human Milk Oligosaccharide |
| Control formula | Placebo comparator | Dietary Supplement: Infant formula without Human Milk OligosaccharideInfant formula without Human Milk Oligosaccharide |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 formula with Human Milk OligosaccharideAlthough breastfeeding is encouraged, the shortage is supplemented with the investigational formula. After obtaining the informed consent, the investigational formula is administered to infants under the doctor's direction until a medical check-up at one-month-old. | Dietary supplement | Investigational formula |
| Infant formula without Human Milk OligosaccharideAlthough breastfeeding is encouraged, the shortage is supplemented with the control formula. After obtaining the informed consent, the control formula is administered to infants under the doctor's direction until a medical check-up at one-month-old. | Dietary supplement | Control formula |
Primary outcome
Growth factors concentration in infant's plasma
Time frame: At one-month-old
The concentration of NGF-beta (pg/mL), BDNF (pg/mL), etc. in infant's plasma will be measured by immunoassay.
Cytokines concentration in infant's plasma
Time frame: At one-month-old
The concentration of IFN-gamma (pg/mL), IL-1alpha (pg/mL), etc. in infant's plasma will be measured by immunoassay.
Infant's gut microbiota occupancy
Time frame: At one-month-old
Total bacterial counts and bifidobacterial counts in stool will be measured by RT-PCR (copy/g wet feces). Occupancy of microbiota in infant's stool will be comprehensively analyzed by DNA/RNA Sequencing (percent).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant formula with Human Milk Oligosaccharide and Infant formula without Human Milk Oligosaccharide in people with Low Birth Weight Infants, run by Meiji Co., Ltd. at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth factors concentration in infant's plasma (time frame: At one-month-old). The study lists 3 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 3 Jul 2023.