InfectionNCT04441359
Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula
A study testing Supplemented formula and Standard formula in people with Infection and Microbial Colonization, run by Beneo-Institute at 8 sites in 2 countries.
Trial summary
The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes. Read more about this study
- Who is it for?
- Ages 1 day to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Infection, Microbial Colonization, Healthy
- What is being tested?
- Supplemented formula and Standard formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 1 Jun 2008to 31 Oct 2010
- 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 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97)
- Healthy babies aged between 0 - 4 months of age
- Babies exclusively fed with an infant formula on enrolment into the study
Who cannot join
- The presence of an infection at the moment of the recruitment or 1 week before recruitment
- The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.)
- Any other diseases related to the immune system (primary immunodeficiency)
- Parents not able to comply with the study follow up (according to physician criteria)
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Spain6 sites
CAP Llefià
Barcelona
Hospital de Nens
Barcelona
Hospital Sant Joan de Deu
Barcelona
University Hospital Vall d'Hebron
Barcelona
Hospital San Cecilio
Granada
Equipo Pediátrico San Francisco
Madrid
Belgium2 sites
ZNA Koningin Paola Kinderziekenhuis
Antwerp
Universitair Ziekenhuis
Brussels
About this study
Official title: Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants
The primary objective of the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.
Read the detailed description
The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).
- Conditions
- Infection, Microbial Colonization, Healthy
- Being tested
- Supplemented formula, Standard formula
- Medical subject headings
- Infections, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supplemented formulaOther
standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans
Standard formulaOther
standard infant formula not supplemented with prebiotic inulin-type fructans
| Study group | Role | What they receive |
|---|---|---|
| supplemented formula | Experimental | Standard formula supplemented with prebiotic inulin-type fructans Receives: Other: Supplemented formula |
| standard formula | Placebo comparator | Standard Formula not supplemented with prebiotic inulin-type fructans Receives: Other: Standard formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infections during first year of life
measured through presence of fever, and number and duration of infectious episodes
Measured: until infant reaches age of 1 year
Secondary outcomes (12)
Stool frequency
Number of depositions per day assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)
Measured: until infant reaches age of 1 year
Stool consistency
Assessed via 1-3 scale with pictograms (1=hard, 2=soft/formed, 3=liquid/semi-liquid), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)
Measured: until infant reaches age of 1 year
Digestive tolerance
Number of vomiting and regurgitation episodes per day and presence of excessive flatulence and infantile colic, assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)
Measured: until infant reaches age of 1 year
Growth
Calculation of z-scores of weight-for-age and length-for-age according to the World Health Organisation (WHO) standards using WHO software (WHO Antro software).
Measured: until infant reaches age of 1 year
Body weight
Assessment of weight (kg) of the nude infant via calibrated electronic scales at all study visits.
Measured: until infant reaches age of 1 year
Body height
Assessment of height (cm) in supine position by using a standard measuring board at all study visits.
Measured: until infant reaches age of 1 year
Head circumference
Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits.
Measured: until infant reaches age of 1 year
Sleeping habits
Assessment of total hours slept and total hours of nocturnal sleeping per day (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).
Measured: until infant reaches age of 1 year
Crying episodes
Assessment of crying episodes (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).
Measured: until infant reaches age of 1 year
Effect on fecal microbiota composition
Quantification of dominant bacterial groups
Measured: until infant reaches age of 1 year
Effect on development of allergy
Presence of clinical symptoms compatible with food allergies, atopic dermatitis, exanthema
Measured: until infant reaches age of 1 year
Effect on immunology markers in feces
secretory immunoglobulin A, calprotectin level
Measured: until infant reaches age of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Jun 2008
- Primary completion31 Oct 2010
- Study completion31 Oct 2010
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 InfectionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beneo-Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratorios Ordesa, European Union
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441359
- Sponsor's protocol ID
- Study protocol June 2008 final
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez-Palmero, M.; Campoy, C.; Urraca, O.; Alonso, J.; Maldonado, J.; Varea, V.; Palencia, J.; Veereman-Wauters, G.; Neumer, F.; Rivero, M.; Vandenplas, Y. Effects of long-term supplementation with a mixture of short and long chain inulin-type oligosaccharides (2013), Annals of Nutrition and Metabolism, suppl. 1, (63), 1-1960.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants
- ClinicalTrials.gov ID
- NCT04441359
- Acronym / sponsor ID
- Study protocol June 2008 final
- Conditions
- Infection, Microbial Colonization, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Beneo-InstituteIndustry (pharma, biotech, devices)
- Collaborators
- Laboratorios Ordesa, European Union
- Study start
- 1 Jun 2008 (actual)
- Primary completion
- 31 Oct 2010 (actual)
- Study completion
- 31 Oct 2010 (actual)
- First posted
- 22 Jun 2020 (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 the present study was to evaluate the effects of long-term supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides on immunological-health related outcomes.
Detailed description
The study primarily aimed to evaluate the effects of long-term supplementation of an infant formula with a mixture of short and long chain inulin-type oligosaccharides on immunological-health related outcomes, as well as on gastrointestinal function and well-being in infants during the first year of life. Effects on infant growth, tolerance and on the composition of fecal microbiota were further objectives of this study. The study was conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy term infants. The two groups of the study are product group (standard infant formula supplemented with inulin-type fructans) and control group (non-supplemented standard infant formula).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supplemented formula | Experimental | Other: Supplemented formulaStandard formula supplemented with prebiotic inulin-type fructans |
| standard formula | Placebo comparator | Other: Standard formulaStandard Formula not supplemented with prebiotic inulin-type fructans |
Who may qualify
- Ages
- 1 day to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for gestational age (between percentiles 3 and 97)
- Healthy babies aged between 0 - 4 months of age
- Babies exclusively fed with an infant formula on enrolment into the study
Key exclusion criteria (4 listed)
- The presence of an infection at the moment of the recruitment or 1 week before recruitment
- The presence of important pathologies (intestinal, cardiopathy, mental retardation, etc.)
- Any other diseases related to the immune system (primary immunodeficiency)
- Parents not able to comply with the study follow up (according to physician criteria)
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 |
|---|---|---|
| Supplemented formulastandard infant formula supplemented with 8 g/L prebiotic inulin-type fructans | Other | supplemented formula |
| Standard formulastandard infant formula not supplemented with prebiotic inulin-type fructans | Other | standard formula |
Primary outcome
Incidence of infections during first year of life
Time frame: until infant reaches age of 1 year
measured through presence of fever, and number and duration of infectious episodes
12 secondary outcomes
Stool frequency
Time frame: until infant reaches age of 1 year
Stool consistency
Time frame: until infant reaches age of 1 year
Digestive tolerance
Time frame: until infant reaches age of 1 year
Growth
Time frame: until infant reaches age of 1 year
Body weight
Time frame: until infant reaches age of 1 year
Body height
Time frame: until infant reaches age of 1 year
Head circumference
Time frame: until infant reaches age of 1 year
Sleeping habits
Time frame: until infant reaches age of 1 year
Crying episodes
Time frame: until infant reaches age of 1 year
Effect on fecal microbiota composition
Time frame: until infant reaches age of 1 year
Effect on development of allergy
Time frame: until infant reaches age of 1 year
Effect on immunology markers in feces
Time frame: until infant reaches age of 1 year
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 22 Jun 2020.
- Results publicationRodriguez-Palmero, M.; Campoy, C.; Urraca, O.; Alonso, J.; Maldonado, J.; Varea, V.; Palencia, J.; Veereman-Wauters, G.; Neumer, F.; Rivero, M.; Vandenplas, Y. Effects of long-term supplementation with a mixture of short and long chain inulin-type oligosaccharides (2013), Annals of Nutrition and Metabolism, suppl. 1, (63), 1-1960.
- 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.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supplemented formula and Standard formula in people with Infection and Microbial Colonization, run by Beneo-Institute at 8 sites in 2 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 3 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 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Belgium. 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?
Incidence of infections during first year of life (time frame: until infant reaches age of 1 year). 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 NCT04441359, 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 22 Jun 2020.