Gastro-intestinal InfectionsNCT01880970
Effect of Starter Formula on Infection Prevention
A study testing starter infant formula with pro and prebiotics in people with Gastro-intestinal Infections and Infections With Fever, run by Société des Produits Nestlé (SPN) at 7 sites in 3 countries.
Trial summary
The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections. Read more about this study
- Who is it for?
- Ages Up to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Gastro-intestinal Infections, Infections With Fever
- What is being tested?
- starter infant formula with pro and prebiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 477 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Oct 2008to Oct 2013
- 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 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn infant
- Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
- Age of infant is ≤ 13 days at the time of enrollment
- Birth weight ≥ 2500g and ≤ 4500g
- For the FF groups: The infant's mother has elected not to breastfeed
- For the BF group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
- Having obtained his/her legal representative's informed consent
Who cannot join
- Congenital illness or malformation that may affect normal growth (especially immunodeficiencies)
- Significant pre-natal and/or post-natal diseases
- Perinatal antibiotic or infants on antibiotics at the time of inclusion
- Infants whose mother has had an acute infection during the last month of pregnancy
- Re-hospitalisation for more than 2 days in the first 14 days of life (exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study)
- Receiving infant formula containing probiotics and/or prebiotics at the time of enrollment
- Newborn whose parents / caregivers cannot be expected to comply with treatment
- Newborn currently participating in another interventional clinical trial
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
France3 sites
Hôpital de la Croix Rousse, Service de réanimation néonatale
Lyon, 69317
Hôpital Arnaud de Villeneuve, Service de pédiatrie 2
Montpellier, 34295
Maternité régionale de Nancy, Service de Néonatologie
Nancy, 54042
Germany3 sites
Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin
Berlin, 13353
Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin
Giessen, 35392
Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin
Potsdam, 14467
Netherlands1 site
Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde
Amsterdam, 1007 MB
About this study
Official title: Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants
The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.
- Being tested
- starter infant formula with pro and prebiotics, Placebo comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
starter infant formula with pro and prebioticsOther
Placebo comparatorOther
| Study group | Role | What they receive |
|---|---|---|
| Starter infant formula with pro and prebiotics | Active comparator | starter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age Receives: Other: starter infant formula with pro and prebiotics |
| starter infant formula without pro and prebiotics | Placebo comparator | starter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age Receives: Other: Placebo comparator |
| Breastfeeding group | No intervention | exclusively breastfeeding during the first 3 months of age, followed by a commercially available Nestlé starter infant formula from 4 to 6 months of age (if applicable) and the follow-up infant formula from 6 to 12 months of age |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea and all infections with fever
Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year
Measured: over 6 months and 1 year
Secondary outcomes (4)
Morbidity
Frequency of episodes of morbidity (adverse events), especially mean event rate of respiratory illnesses per child over 6 months and 1 year
Measured: over 6 months and 1 year
Anthropometry
Anthropometry (weight (kg), length (cm), head circumference (cm) and skin fold)
Measured: until 1 year
Digestive tolerance
Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic)
Measured: until 1 year
Stool characteristics
- Stool bacterial populations (Bifidobacteria, Lactobacilli Species, Clostridium, Bacteroides, Staphylococci epidermitis, presence or absence of B. lactis)
- Stool pH
- Stool and saliva S.IgA
- Stool Alpha 1-antitrypsine as infection/inflammation marker
Measured: at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startOct 2008
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-intestinal InfectionsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- 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
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean Michel Hascoet, Prof., Principal investigator, Maternité régionale de Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880970
- Sponsor's protocol ID
- 07.20.INF
- Status last verified
- Jul 2014
- First submitted
- 17 Jun 2013
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants
- ClinicalTrials.gov ID
- NCT01880970
- Acronym / sponsor ID
- 07.20.INF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 19 Jun 2013 (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 aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Starter infant formula with pro and prebiotics | Active comparator | Other: starter infant formula with pro and prebioticsstarter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age |
| starter infant formula without pro and prebiotics | Placebo comparator | Other: Placebo comparatorstarter infant formula from enrollment till 6 months of age, followed by a commercially available Nestlé follow-up formula from 6 to 12 months of age |
| Breastfeeding group | No intervention | –exclusively breastfeeding during the first 3 months of age, followed by a commercially available Nestlé starter infant formula from 4 to 6 months of age (if applicable) and the follow-up infant formula from 6 to 12 months of age |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy newborn infant
- Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
- Age of infant is ≤ 13 days at the time of enrollment
- Birth weight ≥ 2500g and ≤ 4500g
- For the FF groups: The infant's mother has elected not to breastfeed
Key exclusion criteria (8 listed)
- Congenital illness or malformation that may affect normal growth (especially immunodeficiencies)
- Significant pre-natal and/or post-natal diseases
- Perinatal antibiotic or infants on antibiotics at the time of inclusion
- Infants whose mother has had an acute infection during the last month of pregnancy
- Re-hospitalisation for more than 2 days in the first 14 days of life (exceptionally, infants re-hospitalized because of jaundice may be enrolled in the 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 |
|---|---|---|
| starter infant formula with pro and prebiotics | Other | Starter infant formula with pro and prebiotics |
| Placebo comparator | Other | starter infant formula without pro and prebiotics |
Primary outcome
Diarrhea and all infections with fever
Time frame: over 6 months and 1 year
Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year
4 secondary outcomes
Morbidity
Time frame: over 6 months and 1 year
Anthropometry
Time frame: until 1 year
Digestive tolerance
Time frame: until 1 year
Stool characteristics
Time frame: at 3 and 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 21 Oct 2015.
Related trials for Gastro-intestinal Infections
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingPhase 3
VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
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.
Jean Michel Hascoet, Prof. principal investigator
Maternité régionale de Nancy
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing starter infant formula with pro and prebiotics in people with Gastro-intestinal Infections and Infections With Fever, run by Société des Produits Nestlé (SPN) at 7 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 7 inclusion and 8 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 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France, Germany, Netherlands. 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?
Diarrhea and all infections with fever (time frame: over 6 months and 1 year). 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 21 Oct 2015.