Premature BirthNCT01177475
Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns
A study testing blood samples , feces samples and blood samples, feces samples in people with Premature Birth, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
It seems important to correlate real consumption in bioactives molecules of natural milk versus pasteurized with gut maturation in very preterm infants during small enteral feeding protocol. This objective will be reached through a clinical trial. Read more about this study
- Who is it for?
- Ages 1 day to 1 week
- Conditions the study is for
- Premature Birth
- What is being tested?
- blood samples , feces samples and blood samples, feces samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2010to Jun 2012
- 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 1 week
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children whose term is understood(included) between 28 (27SA+6j past(over)) and 30 LIMITED COMPANIES (30 SA+6j).
- Children fed by digestive stimulation.
- Children in 1st day of food(supply)
- Term of certain child.
- Children not presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
- Children among whom both holders of the parental authority are of more than 18 years old and are not major protected by the law or deprived of freedom.
- Children among whom the relatives(parents) or the legal representatives accepted the participation of their child in this study, and having signed a lit(enlightened) consent.
Who cannot join
- Children been born > 30 LIMITED COMPANIES and < 28 limited companies.
- Children presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
- Children among whom the relatives(parents) or the legal representatives refused that their child participates in the study.
Trial locations and contacts
1 site in 1 country.
About this study
It seems important to correlate real consumption in bioactives molecules of natural milk versus pasteurized with gut maturation in very preterm infants during small enteral feeding protocol. This objective will be reached through a clinical trial.
Read the detailed description
One hundred infants born between 28 and 30 weeks of gestational age will be enrolled in our clinical trial in two neonatal units of Marseille; they will receive small enteral feeding protocol with natural or pasteurized milk (according to the Neonatology Department). Infants monitoring will be conducted from birth until 32 weeks of gestational age through extra-uterine growth, dietary type evolution and determination of gut maturation markers levels in blood (Triglycerides and Cholesterol, PUFA, GLP-2, I and L-FABP, Gastrin, Citrullin) and faeces (Calprotectine). We will also look for new biological markers of intestinal growth, via metabolomic approach. Consumption of bioactives molecules (PUFA, sphingomyelin, sCD14, insulin, leptin, lactoferrin, sphingomyelinase acid and BSSL activity) will be quantified in milk 24h-representative samples received by each newborn. The benefits on digestive tract physiology evolution due to the molecules consumption will be observed from the 32nd week until the 36th week or the end of hospitalization.
- Conditions
- Premature Birth
- Being tested
- blood samples , feces samples, blood samples, feces samples
- Keywords
- kidney-transplant recipients
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samples , feces samplesOther
After the 32nd week until the 36th week or the end of hospitalization,infants received mother's native milk or substitute.
blood samples, feces samplesOther
After the 32nd week until the 36th week or the end of hospitalization,infants continued mother's native milk or received substitute.
| Study group | Role | What they receive |
|---|---|---|
| natural milk | Active comparator | Not described |
| pasteurized milk | Experimental | Not described Receives: Other: blood samples , feces samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
pasteurized milk
infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with pasteurized milk
Measured: 2 years
Secondary outcomes (1)
natural milk
infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with natural milk
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2012
- Study completionJun 2012
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 Premature BirthStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CATHERINE GIRE, Principal investigator, ASSITANCE PUBLIQUE HOPITAUX DE MARSEILLECATHERINE GIRE, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177475
- Sponsor's protocol ID
- 2009-A00666-51
- Other IDs
- 2009 09
- Status last verified
- Sep 2015
- First submitted
- 18 Mar 2010
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Garcia C, Duan RD, Brevaut-Malaty V, Gire C, Millet V, Simeoni U, Bernard M, Armand M. Bioactive compounds in human milk and intestinal health and maturity in preterm newborn: an overview. Cell Mol Biol (Noisy-le-grand). 2013 Dec 30;59(1):108-31.
PubMed 25326648
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns
- ClinicalTrials.gov ID
- NCT01177475
- Acronym / sponsor ID
- 2009-A00666-51
- Conditions
- Premature Birth
- Keywords
- kidney-transplant recipients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Aug 2010 (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.
It seems important to correlate real consumption in bioactives molecules of natural milk versus pasteurized with gut maturation in very preterm infants during small enteral feeding protocol. This objective will be reached through a clinical trial.
Detailed description
One hundred infants born between 28 and 30 weeks of gestational age will be enrolled in our clinical trial in two neonatal units of Marseille; they will receive small enteral feeding protocol with natural or pasteurized milk (according to the Neonatology Department). Infants monitoring will be conducted from birth until 32 weeks of gestational age through extra-uterine growth, dietary type evolution and determination of gut maturation markers levels in blood (Triglycerides and Cholesterol, PUFA, GLP-2, I and L-FABP, Gastrin, Citrullin) and faeces (Calprotectine). We will also look for new biological markers of intestinal growth, via metabolomic approach. Consumption of bioactives molecules (PUFA, sphingomyelin, sCD14, insulin, leptin, lactoferrin, sphingomyelinase acid and BSSL activity) will be quantified in milk 24h-representative samples received by each newborn. The benefits on digestive tract physiology evolution due to the molecules consumption will be observed from the 32nd week until the 36th week or the end of hospitalization.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| natural milk | Active comparator | – |
| pasteurized milk | Experimental | Other: blood samples , feces samples |
Who may qualify
- Ages
- 1 day to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children whose term is understood(included) between 28 (27SA+6j past(over)) and 30 LIMITED COMPANIES (30 SA+6j).
- Children fed by digestive stimulation.
- Children in 1st day of food(supply)
- Term of certain child.
- Children not presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
Key exclusion criteria (3 listed)
- Children been born > 30 LIMITED COMPANIES and < 28 limited companies.
- Children presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
- Children among whom the relatives(parents) or the legal representatives refused that their child participates 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 |
|---|---|---|
| blood samples , feces samplesAfter the 32nd week until the 36th week or the end of hospitalization,infants received mother's native milk or substitute. | Other | pasteurized milk |
| blood samples, feces samplesAfter the 32nd week until the 36th week or the end of hospitalization,infants continued mother's native milk or received substitute. | Other | – |
Primary outcome
pasteurized milk
Time frame: 2 years
infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with pasteurized milk
1 secondary outcome
natural milk
Time frame: 2 years
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 7 May 2026.
- Background: PubMed 25326648Garcia C, Duan RD, Brevaut-Malaty V, Gire C, Millet V, Simeoni U, Bernard M, Armand M. Bioactive compounds in human milk and intestinal health and maturity in preterm newborn: an overview. Cell Mol Biol (Noisy-le-grand). 2013 Dec 30;59(1):108-31.
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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.
CATHERINE GIRE principal investigator
ASSITANCE PUBLIQUE HOPITAUX DE MARSEILLE
CATHERINE GIRE principal investigator
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood samples , feces samples and blood samples, feces samples in people with Premature Birth, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 3 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 7 May 2026. 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 France. 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?
pasteurized milk (time frame: 2 years). 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 NCT01177475, 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 7 May 2026.