Preterms With Gestational Age Ranging From 30 to 35 WeeksNCT00711633
Evaluation of Safety, Tolerance and Effects on the Intestinal Flora of a New Fermented Milk for Preterm Infants
A study testing Milk with probiotic and prebiotic activities and Milk without probiotic and prebiotic activities in people with Preterms With Gestational Age Ranging From 30 to 35 Weeks, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The intestinal flora is a complex ecosystem which is known to play various important functions in the gut. Recent data have reported a delay in intestinal colonization in preterm. Read more about this study
- Who is it for?
- Ages 1 day to 15 days
- Conditions the study is for
- Preterms With Gestational Age Ranging From 30 to 35 Weeks
- What is being tested?
- Milk with probiotic and prebiotic activities and Milk without probiotic and prebiotic activities
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2002to Jun 2007
- 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 15 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterms with gestational age ranging from 30 to 35 weeks
- Eutrophic
- Formula feeding
Who cannot join
- Malformation or metabolic disease
- Newborns whose parents did not provide informed consent
- Contraindication to enteral feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Fermented Formula Without Live Bacteria for Preterm Infants: Effects on Microbiota Species and Intestinal Inflammatory Markers
The intestinal flora is a complex ecosystem which is known to play various important functions in the gut. Recent data have reported a delay in intestinal colonization in preterm. Modulating the intestinal flora through dietary supplementation with probiotics or prebiotics has been shown to improve digestive and general outcomes in full-term infants.The aim of this study was to evaluate the clinical tolerance, the effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants.
Read the detailed description
This prospective, randomized, double-blind, controlled study evaluated the safety and effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants. Preterm infants with a gestational age (GA) ranging from 30 to 35 weeks and whose mother chose formula feeding were enrolled during their first three days of life. Both parents provided informed written consent. Infants were randomly assigned to receive either the fermented preterm formula (FPF) or, as a control, a formula adapted for preterm infants (PF). The PF was formulated to meet the nutritional needs of preterm infants. The FPF was identical, except for a manufacturing process including a fermentation step with two probiotic strains, Bifidobacterium breve C50 and Streptococcus thermophilus 065, inactivated by heat at the end of the manufacturing process. This process conferred a probiotic/prebiotic activity.For each neonate, background information about the pregnancy and neonatal parameters were collected. Anthropometric parameters (weight, height, head circumference); gastrointestinal tolerance parameters (abdominal distension, gastric residuals, rectal bleeding, NEC); drug administration; and intake of formula and mother's milk were recorded twice a week until discharge. Stools were collected twice a week from diapers for microbiological analysis and measurement of fecal inflammatory markers. All samples were immediately stored at -80°C.
- Being tested
- Milk with probiotic and prebiotic activities, Milk without probiotic and prebiotic activities
- Keywords
- Premature birth,, infant,, infant formula,, bacterial colonization,, Bifidobacterium,, calprotectin
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk with probiotic and prebiotic activitiesDietary supplement
Comparison of two different formula for preterm infants
Milk without probiotic and prebiotic activitiesDietary supplement
Also called Comparison of formula for preterm infants
Comparison of formula for preterm infants
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | the fermented preterm formula (FPF) Receives: Dietary Supplement: Milk with probiotic and prebiotic activities |
| 2 | Placebo comparator | formula adapted for preterm infants (PF) Receives: Dietary Supplement: Milk without probiotic and prebiotic activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow-up of the number of colonized infants and the bacterial colonization levels
Measured: weekly until hospital discharge
Secondary outcomes (2)
Clinical tolerance
Measured: weekly until hospital discharge
Levels of intestinal immune and inflammatory markers
Measured: weekly until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startDec 2002
- Primary completionFeb 2005
- Study completionJun 2007
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 Preterms With Gestational Age Ranging From 30 to 35 WeeksStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Blédina SA, Villefranche sur Saône, France
- Investigators
- Florence Campeotto, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711633
- Sponsor's protocol ID
- 1977/06-05-02
- Status last verified
- Jun 2008
- First submitted
- 4 Jul 2008
- Last updated
- 9 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Campeotto F, Waligora-Dupriet AJ, Doucet-Populaire F, Kalach N, Dupont C, Butel MJ. [Establishment of the intestinal microflora in neonates]. Gastroenterol Clin Biol. 2007 May;31(5):533-42. doi: 10.1016/s0399-8320(07)89424-3. French.
PubMed 17541346
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Fermented Formula Without Live Bacteria for Preterm Infants: Effects on Microbiota Species and Intestinal Inflammatory Markers
- ClinicalTrials.gov ID
- NCT00711633
- Acronym / sponsor ID
- 1977/06-05-02
- Keywords
- Premature birth,, infant,, infant formula,, bacterial colonization,, Bifidobacterium,, calprotectin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Blédina SA, Villefranche sur Saône, France
- Study start
- Dec 2002
- Primary completion
- Feb 2005 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 9 Jul 2008 (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 intestinal flora is a complex ecosystem which is known to play various important functions in the gut. Recent data have reported a delay in intestinal colonization in preterm. Modulating the intestinal flora through dietary supplementation with probiotics or prebiotics has been shown to improve digestive and general outcomes in full-term infants.The aim of this study was to evaluate the clinical tolerance, the effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants.
Detailed description
This prospective, randomized, double-blind, controlled study evaluated the safety and effect on gut microbiota, and the mucosal inflammatory responses to a fermented milk in preterm infants. Preterm infants with a gestational age (GA) ranging from 30 to 35 weeks and whose mother chose formula feeding were enrolled during their first three days of life. Both parents provided informed written consent. Infants were randomly assigned to receive either the fermented preterm formula (FPF) or, as a control, a formula adapted for preterm infants (PF). The PF was formulated to meet the nutritional needs of preterm infants. The FPF was identical, except for a manufacturing process including a fermentation step with two probiotic strains, Bifidobacterium breve C50 and Streptococcus thermophilus 065, inactivated by heat at the end of the manufacturing process. This process conferred a probiotic/prebiotic activity.For each neonate, background information about the pregnancy and neonatal parameters were collected. Anthropometric parameters (weight, height, head circumference); gastrointestinal tolerance parameters (abdominal distension, gastric residuals, rectal bleeding, NEC); drug administration; and intake of formula and mother's milk were recorded twice a week until discharge. Stools were collected twice a week from diapers for microbiological analysis and measurement of fecal inflammatory markers. All samples were immediately stored at -80°C.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Milk with probiotic and prebiotic activitiesthe fermented preterm formula (FPF) |
| 2 | Placebo comparator | Dietary Supplement: Milk without probiotic and prebiotic activitiesformula adapted for preterm infants (PF) |
Who may qualify
- Ages
- 1 day to 15 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterms with gestational age ranging from 30 to 35 weeks
- Eutrophic
- Formula feeding
Key exclusion criteria (3 listed)
- Malformation or metabolic disease
- Newborns whose parents did not provide informed consent
- Contraindication to enteral feeding
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 |
|---|---|---|
| Milk with probiotic and prebiotic activitiesComparison of two different formula for preterm infants | Dietary supplement | 1 |
| Milk without probiotic and prebiotic activitiesAlso: Comparison of formula for preterm infantsComparison of formula for preterm infants | Dietary supplement | 2 |
Primary outcome
Follow-up of the number of colonized infants and the bacterial colonization levels
Time frame: weekly until hospital discharge
2 secondary outcomes
Clinical tolerance
Time frame: weekly until hospital discharge
Levels of intestinal immune and inflammatory markers
Time frame: weekly until hospital discharge
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 9 Jul 2008.
- Background: PubMed 17541346Campeotto F, Waligora-Dupriet AJ, Doucet-Populaire F, Kalach N, Dupont C, Butel MJ. [Establishment of the intestinal microflora in neonates]. Gastroenterol Clin Biol. 2007 May;31(5):533-42. doi: 10.1016/s0399-8320(07)89424-3. French.
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.
Florence Campeotto, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milk with probiotic and prebiotic activities and Milk without probiotic and prebiotic activities in people with Preterms With Gestational Age Ranging From 30 to 35 Weeks, run by Assistance Publique - Hôpitaux de Paris 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 3 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 9 Jul 2008. 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. 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?
Follow-up of the number of colonized infants and the bacterial colonization levels (time frame: weekly until hospital discharge). 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 NCT00711633, 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 9 Jul 2008.