Infant NutritionNCT03513744
Study Evaluating Growth and Tolerance of Infant Formula Containing HMOs
A study testing human milk oligosaccharides in people with Infant Nutrition, run by Jennewein Biotechnologie GmbH at 9 sites in 3 countries.
Trial summary
The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the… Read more about this study
- Who is it for?
- Ages 1 day to 13 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- human milk oligosaccharides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 19 Nov 2018to 5 Apr 2021
- 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 1 day to 13 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton birth
- Full-term infant (37 - 42 weeks of gestational age)
- APGAR score of 9 or 10
- Birth weight 2500 - 4500 g
Who cannot join
- clinically significant condition/ disorder
- Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula
- readmission to hospital (except for hyperbilirubinemia)
- allergy to cow's milk
- participation in another study
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Spain5 sites
Hospital HM Puerta del Sur
Madrid, 28015
Hospital HM Monteprincipe
Madrid, 28660
Hospital HM Nuevo Belen
Madrid, 28938
Hospital Universitario Sant Joan de Reus
Reus, 43204
Hospital Joan XXII of Tarragona
Tarragona, 43005
Germany2 sites
Facharzt für Kinder und Jugendmedizin
Mannheim, 68161
Klinikum Südstadt Rostock
Rostock, 18059
Italy2 sites
ASST Spedali Civili di Brescia - Presidio Ospedale dei Bambini
Brescia, 25123
Ospedale San Raffaele
Milan, 20132
About this study
Official title: Evaluation of Nutritional Suitability and Tolerability of a Human Milk Oligosaccharide (HMO) Mix in Infant Formula for Term Infants
The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.
Read the detailed description
The main goal of the study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth of term infants (evaluated per weight gain, body length and head circumference), in comparison with infant formula without human milk oligosaccharides, when the formula is fed exclusivly in the first four month of life. Additionally, a comparison of the two formula fed groups against a reference group with breastfed infants as well as the WHO growth standard reference tables will be performed. An assessment of safety and tolerability will be performed as well.
As a secondary out come of the study, we will examine the effect of the formula on the infant microbiome, as well as the HMO status of the mother's milk towards the microbial composition of the infant microbiome.
- Conditions
- Infant Nutrition
- Being tested
- human milk oligosaccharides
- Keywords
- human milk oligosaccharides, infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human milk oligosaccharidesDietary supplement
mixture of five different human milk oligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| infant formula containing five HMOs | Experimental | Not described Receives: Dietary Supplement: human milk oligosaccharides |
| infant formula | No intervention | Not described |
| breast milk group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of body weight (in grams) of term infants
growth, assessed by body weight gain, of term infants from enrollment to 4 month of life
Measured: 4 month
Secondary outcomes (2)
assessment of body length (in centimeter) of term infants
growth, assessed as body length, of term infants from enrollment to 4 month of life
Measured: 4 month
assessment of head circumference (in centimeter) of term infants
growth, assessed as head circumference, of term infants from enrollment to 4month of life
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start19 Nov 2018
- Primary completion3 Mar 2021
- Study completion5 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant NutritionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jennewein Biotechnologie GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
- Investigators
- Frank Jochum, Dr. med., Principal investigator, Universitaetsmedizin Berlin, Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513744
- Sponsor's protocol ID
- JEN/008017
- Status last verified
- Oct 2023
- First submitted
- 12 Apr 2018
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutritional Suitability and Tolerability of a Human Milk Oligosaccharide (HMO) Mix in Infant Formula for Term Infants
- ClinicalTrials.gov ID
- NCT03513744
- Acronym / sponsor ID
- JEN/008017
- Conditions
- Infant Nutrition
- Keywords
- human milk oligosaccharides, infant formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Jennewein Biotechnologie GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 3 Mar 2021 (actual)
- Study completion
- 5 Apr 2021 (actual)
- First posted
- 2 May 2018 (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.
The primary objective of this clinical study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth (evaluated per weight gain), in comparison with infant formula without human milk oligosaccharides, when the formula is fed as the sole source of nutrition.
Detailed description
The main goal of the study is to investigate the suitability of an infant formula containing five different human milk oligosaccharides to support normal physical growth of term infants (evaluated per weight gain, body length and head circumference), in comparison with infant formula without human milk oligosaccharides, when the formula is fed exclusivly in the first four month of life. Additionally, a comparison of the two formula fed groups against a reference group with breastfed infants as well as the WHO growth standard reference tables will be performed. An assessment of safety and tolerability will be performed as well.
As a secondary out come of the study, we will examine the effect of the formula on the infant microbiome, as well as the HMO status of the mother's milk towards the microbial composition of the infant microbiome.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| infant formula containing five HMOs | Experimental | Dietary Supplement: human milk oligosaccharides |
| infant formula | No intervention | – |
| breast milk group | No intervention | – |
Who may qualify
- Ages
- 1 day to 13 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Singleton birth
- Full-term infant (37 - 42 weeks of gestational age)
- APGAR score of 9 or 10
- Birth weight 2500 - 4500 g
Key exclusion criteria (5 listed)
- clinically significant condition/ disorder
- Adverse maternal of fetal medical history that may influence growth/development of the subject or tolerance of the infant formula
- readmission to hospital (except for hyperbilirubinemia)
- allergy to cow's milk
- participation in another study
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 |
|---|---|---|
| human milk oligosaccharidesmixture of five different human milk oligosaccharides | Dietary supplement | infant formula containing five HMOs |
Primary outcome
assessment of body weight (in grams) of term infants
Time frame: 4 month
growth, assessed by body weight gain, of term infants from enrollment to 4 month of life
2 secondary outcomes
assessment of body length (in centimeter) of term infants
Time frame: 4 month
assessment of head circumference (in centimeter) of term infants
Time frame: 4 month
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 16 Oct 2023.
Related trials for Infant Nutrition
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Not yet recruitingObservational study
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Cardiac Abnormalities, Nutrient Intake
RecruitingObservational study
Longitudinal Prospective Study of Maternal and Child Nutrition in Arkansas
Maternal Nutrition, Infant Nutrition
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Recruiting
Protocol-driven Nutrition in Preterm Infants
Preterm Infants
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.
Frank Jochum, Dr. med. principal investigator
Universitaetsmedizin Berlin, Charité
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human milk oligosaccharides in people with Infant Nutrition, run by Jennewein Biotechnologie GmbH at 9 sites in 3 countries.
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 5 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: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Germany, Italy. 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?
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?
assessment of body weight (in grams) of term infants (time frame: 4 month). 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 16 Oct 2023.