Infant FormulaNCT01625273
Supplementation of Infant Formula With Synbiotics
A study testing Lactobacillus paracasei paracasei strain F19 in people with Infant Formula, run by Arla Foods at 1 site in Poland.
Trial summary
The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Formula
- What is being tested?
- Lactobacillus paracasei paracasei strain F19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2010to Apr 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 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy infants of mothers who voluntarily resigned completely from breastfeeding
- infant age 28 days
- delivered between 38 and 42 weeks of gestation
- vaginal delivery
- birth weight > 2700 g and < 4200 g
- parent or the subject's legal representative has to speak and understand Polish
Who cannot join
- fully or partially breastfed infants
- malformations, handicaps or congenital diseases that could affect normal growth
- treatment with antibiotics
- fed infant formula with pre- and/or probiotics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplementation of Infant Formula With the Synbiotics (Lactobacillus Paracasei Ssp. Paracasei Strain F19 and Fructo- and Galactooligosaccharides).
The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.
- Conditions
- Infant Formula
- Being tested
- Lactobacillus paracasei paracasei strain F19
- Keywords
- F19, Lactobacillus paracasei paracasei
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus paracasei paracasei strain F19Other
Also called F19
Provided in an infant formula, 10^8 CFU per day from 28 days to 6 months of infant age
| Study group | Role | What they receive |
|---|---|---|
| IF (Infant formula) | No intervention | Not described |
| IF with L. paracasei strain F19 | Experimental | Not described Receives: Other: Lactobacillus paracasei paracasei strain F19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth (body weight, length, head circumference)
Measured: From 28 days to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJan 2010
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infant FormulaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arla Foods
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hania Szajewska, MD, Principal investigator, Samodzielny Publiczny Dziecięcy Szpital, WarsawJacek Witwicki, MD, Principal investigator, Samodzielny Publiczny Dziecięcy Szpital Kliniczny, Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625273
- Sponsor's protocol ID
- KB/205/2010
- Status last verified
- Jan 2017
- First submitted
- 19 Jun 2012
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sjodin KS, Sjodin A, Ruszczynski M, Kristensen MB, Hernell O, Szajewska H, West CE. Targeting the gut-lung axis by synbiotic feeding to infants in a randomized controlled trial. BMC Biol. 2023 Feb 20;21(1):38. doi: 10.1186/s12915-023-01531-3.
PubMed 36803508
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Infant Formula With the Synbiotics (Lactobacillus Paracasei Ssp. Paracasei Strain F19 and Fructo- and Galactooligosaccharides).
- ClinicalTrials.gov ID
- NCT01625273
- Acronym / sponsor ID
- KB/205/2010
- Conditions
- Infant Formula
- Keywords
- F19, Lactobacillus paracasei paracasei
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Arla FoodsIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Jun 2012 (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.
The primary hypothesis is that Lactobacillus paracasei ssp. paracasei strain F19 in an infant formula containing FOS/GOS is safe and tolerable for use in infants from 0 to 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IF (Infant formula) | No intervention | – |
| IF with L. paracasei strain F19 | Experimental | Other: Lactobacillus paracasei paracasei strain F19 |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- healthy infants of mothers who voluntarily resigned completely from breastfeeding
- infant age 28 days
- delivered between 38 and 42 weeks of gestation
- vaginal delivery
- birth weight > 2700 g and < 4200 g
Key exclusion criteria (4 listed)
- fully or partially breastfed infants
- malformations, handicaps or congenital diseases that could affect normal growth
- treatment with antibiotics
- fed infant formula with pre- and/or probiotics
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 |
|---|---|---|
| Lactobacillus paracasei paracasei strain F19Also: F19Provided in an infant formula, 10^8 CFU per day from 28 days to 6 months of infant age | Other | IF with L. paracasei strain F19 |
Primary outcome
Growth (body weight, length, head circumference)
Time frame: From 28 days to 6 months
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 26 Jan 2017.
- Derived from this study: PubMed 36803508Sjodin KS, Sjodin A, Ruszczynski M, Kristensen MB, Hernell O, Szajewska H, West CE. Targeting the gut-lung axis by synbiotic feeding to infants in a randomized controlled trial. BMC Biol. 2023 Feb 20;21(1):38. doi: 10.1186/s12915-023-01531-3.
- Individual participant dataSharing planned: No
Related trials for Infant Formula
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Recruiting
Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
Growth
Recruiting
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
Healthy Term Infants
Not yet recruitingPhase 3
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
Infant ALL
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.
Hania Szajewska, MD principal investigator
Samodzielny Publiczny Dziecięcy Szpital, Warsaw
Jacek Witwicki, MD principal investigator
Samodzielny Publiczny Dziecięcy Szpital Kliniczny, Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus paracasei paracasei strain F19 in people with Infant Formula, run by Arla Foods at 1 site in Poland.
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 6 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: finished, as of the sponsor's last update on 26 Jan 2017. 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 Poland. 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?
Growth (body weight, length, head circumference) (time frame: From 28 days to 6 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 NCT01625273, which also lists 1 linked publication.
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 26 Jan 2017.