AzTrials
AzTrials

Duration of Parenteral NutritionNCT00290576

Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns

A study testing Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG ) in people with Duration of Parenteral Nutrition, run by Nantes University Hospital at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Symbiotic interaction between probiotics ("Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. Read more about this study

Who is it for?
Ages 1 day to 2 weeks
Conditions the study is for
Duration of Parenteral Nutrition
What is being tested?
Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )
How many people
127 participants
Where
1 siteFrance
Study dates
Apr 2004to Jun 2008
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 2 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • newborns (< 2 weeks of life)
  • 32 Weeks of Gestation,
  • weight < 1500g,
  • Enteral nutrition begun,
  • Clinical stability,
  • Signed consent form from both parents.

Who cannot join

  • newborns (>= 2 weeks of life),
  • weight >= 1500g,
  • pathology avoiding the start of the enteral nutrition,
  • other pathologies of those due to premature and its complications,
  • No signed consent form.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Nantes University Hospital

    Nantes, 44093

Other trials in France

About this study

Official title: Digestive and Nutritional Effects of Probiotics (Bifidobacterium Longum and Lactobacillus GG) Supplementation in Premature Newborns

Symbiotic interaction between probiotics ("Living alimentary microbials supplemental, affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and human digestive tract was amply experimented and seems to be an interesting solution to orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group. Nevertheless, our aim is to test clinical efficiency of two new probiotics strains. Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21) and safety (Adverse Events) in very premature babies.

Being tested
Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )
Keywords
Digestive and Nutritional Effects, Safety and Growth, Feeding Tolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )Dietary supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition

    Measured: at D14 and D21.

Secondary outcomes (4)

  1. Age when Enteral Nutrition reaches 50% of Nutritional needs.

  2. Incidence of Nosocomial Infections.

  3. Composition of Colic Flora.

  4. Fecal Calprotectin as Index of Inflammation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2006 (estimated)
  2. Study startApr 2004
  3. Primary completionApr 2007
  4. Study completionJun 2008

Resources

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
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00290576
Sponsor's protocol ID
BRD/04/2-Y
Status last verified
Jun 2008
First submitted
10 Feb 2006
Last updated
9 Jun 2008
Results posted
No

Publications

  • Bourdon A, Rouge C, Legrand A, Des Robert C, Piloquet H, Vodovar M, Voyer M, Roze JC, Darmaun D. Urinary citrulline in very low birth weight preterm infants receiving intravenous nutrition. Br J Nutr. 2012 Oct;108(7):1150-4. doi: 10.1017/S0007114511006660. Epub 2011 Dec 12.

    PubMed 22152114

  • Rouge C, Piloquet H, Butel MJ, Berger B, Rochat F, Ferraris L, Des Robert C, Legrand A, de la Cochetiere MF, N'Guyen JM, Vodovar M, Voyer M, Darmaun D, Roze JC. Oral supplementation with probiotics in very-low-birth-weight preterm infants: a randomized, double-blind, placebo-controlled trial. Am J Clin Nutr. 2009 Jun;89(6):1828-35. doi: 10.3945/ajcn.2008.26919. Epub 2009 Apr 15.

    PubMed 19369375

Questions about this trial

What is this clinical trial studying?

A study testing Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG ) in people with Duration of Parenteral Nutrition, run by Nantes University Hospital 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 6 inclusion and 5 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 Jun 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. 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?

Success if Patient reaches 50% of Nutritional needs by Enteral Nutrition (time frame: at D14 and D21.). 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 NCT00290576, which also lists 2 linked publications.

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 Jun 2008.

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