Nutritional SafetyNCT00486148

Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS)

A study testing Infant formula (with GOS) in people with Nutritional Safety, run by Heinz Italia SpA at 7 sites in Italy.

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

The purpose of this study is to determine the safety and efficacy of an infant formula supplemented with a "prebiotic" component (GOS) in improving the gut microflora balance, mimicking that of breast-fed infants. Read more about this study

Who is it for?: Ages 1 day to 15 days
Conditions the study is for: Nutritional Safety
What is being tested?: Infant formula (with GOS)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 360 participants
Where: 7 sitesItaly
Study dates: Feb 2006to Jun 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 1 day to 15 days
All sexes
No healthy volunteers
Child

Who may be able to join

Healthy infants of both sexes, born at term with natural labor or cesarean birth
Single birth
Infant born between 37th - 42th gestation week (included)
Infant with birth weight ≥ 2500 g
APGAR score after 5 minutes of life > 7
Infant born from parents of Caucasian race

Show all 9Show fewer

Exclusive breast feeding or formula feeding within 15 days from birth.
Consensus form signed by both parents or by the legal tutor properly informed of the study.
Parents able to understand the protocol requirements and to fill out the infants Diary.

Who cannot join

Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days.
Diseases jeopardizing intrauterine growth.
Infant born from mother suffering from dismetabolic and/or chronic diseases.
Unknown father
Infant with parents who might not report at hospital controls or not follow the protocol.
Infant already enrolled or selected for another clinical trial.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Italy7 sites

"Casa Pia Ospitaliera Uboldo" Unità Operativa di Pediatria e Neonatologia
Cernusco Sul Naviglio (Milan), 20063
Ospedale "Sacra Famiglia del Fatebenefratelli" Unità Operativa di Pediatria e Neonatologia
Erba (Como), 22036
Ospedale "Santa Maria delle Stelle" Unità Operativa di Pediatria e Neonatologia
Melzo (MI), 20066
Azienda ospedaliera "San Paolo", Dipartimento di Pediatria
Milan, 20142
Ospedale "San Carlo Borromeo" Unità Operativa di Pediatria
Milan, 20152
Azienda Ospedaliera "Luigi Sacco" Unità Operativa di Pediatria
Milan, 20157
Ospedale Civile "G. da Saliceto" Unità Operativa di Pediatria
Piacenza, 29100

Other trials in Italy

About this study

Official title: Randomized, Double Blind Study to Evaluate the Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS) in Healthy, Full Term Infants

Read the detailed description

Oligosaccharides are one of the major breast milk components. They are not digested and reach the colon where they're used by selected groups of microflora positive bacteria, specifically bifidobacteria and lactobacilli.

Therefore, oligosaccharides have prebiotic effects accountable for health benefits in infants.

Over the last years the supplementation of infant formulae has been studied to mimic breast milk prebiotic functions enhancing gut microflora growth similar to that of breast fed infants.

However further scientific data are necessary to support the efficacy of the supplementation of oligosaccharide in infant formulae.

Conditions: Nutritional Safety
Being tested: Infant formula (with GOS)
Keywords: Formula, Feeding, Healthy, Full, Term, Infants

What participants receive

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

Infant formula (with GOS)Other
Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides

Study groups in NCT00486148
Study group	Role	What they receive
group "S"	No intervention	Breast milk
group "A"	No intervention	Control Infant formula
group "B"	Experimental	Infant formula supplemented with 0.4 g/100 ml of oligosaccharides Receives: Other: Infant formula (with GOS)

What is being measured

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

The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever.
Measured: Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily.

Secondary outcomes (1)

The prebiotic effect through the control of the feces consistency and frequency, the incidence of gaseous colics and microbiological analyses of the fecal samples.
Measured: Feces consistency and frequency, and incidence of gaseous colics, microbiological analyses of the fecal samples on enrolment and after 1 and 2 months of life.

Timeline

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

Feb 2006Jun 2013

First posted13 Jun 2007 (estimated)
Study startFeb 2006
Primary completionOct 2011
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Nutritional SafetyStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00486148
Sponsor's protocol ID: PLA-1-GOS-05
Status last verified: Mar 2015
First submitted: 12 Jun 2007
Last updated: 18 Mar 2015
Results posted: No
Data monitoring committee: No

Publications

Mountzouris KC, McCartney AL, Gibson GR. Intestinal microflora of human infants and current trends for its nutritional modulation. Br J Nutr. 2002 May;87(5):405-20. doi: 10.1079/BJNBJN2002563.
PubMed 12010580
Agostoni C, Axelsson I, Goulet O, Koletzko B, Michaelsen KF, Puntis JW, Rigo J, Shamir R, Szajewska H, Turck D; ESPGHAN Committee on Nutrition. Prebiotic oligosaccharides in dietetic products for infants: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2004 Nov;39(5):465-73. doi: 10.1097/00005176-200411000-00003.
PubMed 15572882
Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995 Jun;125(6):1401-12. doi: 10.1093/jn/125.6.1401.
PubMed 7782892
Macfarlane GT, Cummings JH. Probiotics and prebiotics: can regulating the activities of intestinal bacteria benefit health? BMJ. 1999 Apr 10;318(7189):999-1003. doi: 10.1136/bmj.318.7189.999. No abstract available.
PubMed 10195977
Moro G, Minoli I, Mosca M, Fanaro S, Jelinek J, Stahl B, Boehm G. Dosage-related bifidogenic effects of galacto- and fructooligosaccharides in formula-fed term infants. J Pediatr Gastroenterol Nutr. 2002 Mar;34(3):291-5. doi: 10.1097/00005176-200203000-00014.
PubMed 11964956
Boehm G, Lidestri M, Casetta P, Jelinek J, Negretti F, Stahl B, Marini A. Supplementation of a bovine milk formula with an oligosaccharide mixture increases counts of faecal bifidobacteria in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2002 May;86(3):F178-81. doi: 10.1136/fn.86.3.f178.
PubMed 11978748
Schmelzle H, Wirth S, Skopnik H, Radke M, Knol J, Bockler HM, Bronstrup A, Wells J, Fusch C. Randomized double-blind study of the nutritional efficacy and bifidogenicity of a new infant formula containing partially hydrolyzed protein, a high beta-palmitic acid level, and nondigestible oligosaccharides. J Pediatr Gastroenterol Nutr. 2003 Mar;36(3):343-51. doi: 10.1097/00005176-200303000-00008.
PubMed 12604972
Long SS, Swenson RM. Development of anaerobic fecal flora in healthy newborn infants. J Pediatr. 1977 Aug;91(2):298-301. doi: 10.1016/s0022-3476(77)80836-6.
PubMed 874690
Rotimi VO, Duerden BI. The development of the bacterial flora in normal neonates. J Med Microbiol. 1981 Feb;14(1):51-62. doi: 10.1099/00222615-14-1-51.
PubMed 7463467
Orrhage K, Nord CE. Factors controlling the bacterial colonization of the intestine in breastfed infants. Acta Paediatr Suppl. 1999 Aug;88(430):47-57. doi: 10.1111/j.1651-2227.1999.tb01300.x.
PubMed 10569223
Benno Y, Sawada K, Mitsuoka T. The intestinal microflora of infants: composition of fecal flora in breast-fed and bottle-fed infants. Microbiol Immunol. 1984;28(9):975-86. doi: 10.1111/j.1348-0421.1984.tb00754.x.
PubMed 6513816
Lundequist B, Nord CE, Winberg J. The composition of the faecal microflora in breastfed and bottle fed infants from birth to eight weeks. Acta Paediatr Scand. 1985 Jan;74(1):45-51. doi: 10.1111/j.1651-2227.1985.tb10919.x.
PubMed 3984727
Howie PW. Protective effect of breastfeeding against infection in the first and second six months of life. Adv Exp Med Biol. 2002;503:141-7. doi: 10.1007/978-1-4615-0559-4_16. No abstract available.
PubMed 12026013
Heine W, Mohr C, Wutzke KD. Host-microflora correlations in infant nutrition. Prog Food Nutr Sci. 1992;16(2):181-97.
PubMed 1496120
Kunz C, Rodriguez-Palmero M, Koletzko B, Jensen R. Nutritional and biochemical properties of human milk, Part I: General aspects, proteins, and carbohydrates. Clin Perinatol. 1999 Jun;26(2):307-33.
PubMed 10394490

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Nutritional Safety trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double Blind Study to Evaluate the Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides (GOS) in Healthy, Full Term Infants
ClinicalTrials.gov ID: NCT00486148
Acronym / sponsor ID: PLA-1-GOS-05
Conditions: Nutritional Safety
Keywords: Formula, Feeding, Healthy, Full, Term, Infants
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: Heinz Italia SpAIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Oct 2011 (actual)
Study completion: Jun 2013 (actual)
First posted: 13 Jun 2007 (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.

Detailed description

Therefore, oligosaccharides have prebiotic effects accountable for health benefits in infants.

Over the last years the supplementation of infant formulae has been studied to mimic breast milk prebiotic functions enhancing gut microflora growth similar to that of breast fed infants.

However further scientific data are necessary to support the efficacy of the supplementation of oligosaccharide in infant formulae.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
group "S"	No intervention	–Breast milk
group "A"	No intervention	–Control Infant formula
group "B"	Experimental	Other: Infant formula (with GOS)Infant formula supplemented with 0.4 g/100 ml of oligosaccharides

Who may qualify

Ages: 1 day to 15 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (9 listed)

Healthy infants of both sexes, born at term with natural labor or cesarean birth
Single birth
Infant born between 37th - 42th gestation week (included)
Infant with birth weight ≥ 2500 g
APGAR score after 5 minutes of life > 7

Key exclusion criteria (6 listed)

Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days.
Diseases jeopardizing intrauterine growth.
Infant born from mother suffering from dismetabolic and/or chronic diseases.
Unknown father
Infant with parents who might not report at hospital controls or not follow the protocol.

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
Infant formula (with GOS)Infant formula supplemented with 0.4 g/100 ml of galacto-oligosaccharides	Other	group "B"

Primary outcome

The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever.
Time frame: Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily.

1 secondary outcome

The prebiotic effect through the control of the feces consistency and frequency, the incidence of gaseous colics and microbiological analyses of the fecal samples.
Time frame: Feces consistency and frequency, and incidence of gaseous colics, microbiological analyses of the fecal samples on enrolment and after 1 and 2 months of life.

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 18 Mar 2015.
Background: PubMed 12010580Mountzouris KC, McCartney AL, Gibson GR. Intestinal microflora of human infants and current trends for its nutritional modulation. Br J Nutr. 2002 May;87(5):405-20. doi: 10.1079/BJNBJN2002563.
Background: PubMed 15572882Agostoni C, Axelsson I, Goulet O, Koletzko B, Michaelsen KF, Puntis JW, Rigo J, Shamir R, Szajewska H, Turck D; ESPGHAN Committee on Nutrition. Prebiotic oligosaccharides in dietetic products for infants: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2004 Nov;39(5):465-73. doi: 10.1097/00005176-200411000-00003.
Background: PubMed 7782892Gibson GR, Roberfroid MB. Dietary modulation of the human colonic microbiota: introducing the concept of prebiotics. J Nutr. 1995 Jun;125(6):1401-12. doi: 10.1093/jn/125.6.1401.
Background: PubMed 10195977Macfarlane GT, Cummings JH. Probiotics and prebiotics: can regulating the activities of intestinal bacteria benefit health? BMJ. 1999 Apr 10;318(7189):999-1003. doi: 10.1136/bmj.318.7189.999. No abstract available.
Background: PubMed 11964956Moro G, Minoli I, Mosca M, Fanaro S, Jelinek J, Stahl B, Boehm G. Dosage-related bifidogenic effects of galacto- and fructooligosaccharides in formula-fed term infants. J Pediatr Gastroenterol Nutr. 2002 Mar;34(3):291-5. doi: 10.1097/00005176-200203000-00014.
Background: PubMed 11978748Boehm G, Lidestri M, Casetta P, Jelinek J, Negretti F, Stahl B, Marini A. Supplementation of a bovine milk formula with an oligosaccharide mixture increases counts of faecal bifidobacteria in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2002 May;86(3):F178-81. doi: 10.1136/fn.86.3.f178.
Background: PubMed 12604972Schmelzle H, Wirth S, Skopnik H, Radke M, Knol J, Bockler HM, Bronstrup A, Wells J, Fusch C. Randomized double-blind study of the nutritional efficacy and bifidogenicity of a new infant formula containing partially hydrolyzed protein, a high beta-palmitic acid level, and nondigestible oligosaccharides. J Pediatr Gastroenterol Nutr. 2003 Mar;36(3):343-51. doi: 10.1097/00005176-200303000-00008.
Background: PubMed 874690Long SS, Swenson RM. Development of anaerobic fecal flora in healthy newborn infants. J Pediatr. 1977 Aug;91(2):298-301. doi: 10.1016/s0022-3476(77)80836-6.
Background: PubMed 7463467Rotimi VO, Duerden BI. The development of the bacterial flora in normal neonates. J Med Microbiol. 1981 Feb;14(1):51-62. doi: 10.1099/00222615-14-1-51.
Background: PubMed 10569223Orrhage K, Nord CE. Factors controlling the bacterial colonization of the intestine in breastfed infants. Acta Paediatr Suppl. 1999 Aug;88(430):47-57. doi: 10.1111/j.1651-2227.1999.tb01300.x.
Background: PubMed 6513816Benno Y, Sawada K, Mitsuoka T. The intestinal microflora of infants: composition of fecal flora in breast-fed and bottle-fed infants. Microbiol Immunol. 1984;28(9):975-86. doi: 10.1111/j.1348-0421.1984.tb00754.x.
Background: PubMed 3984727Lundequist B, Nord CE, Winberg J. The composition of the faecal microflora in breastfed and bottle fed infants from birth to eight weeks. Acta Paediatr Scand. 1985 Jan;74(1):45-51. doi: 10.1111/j.1651-2227.1985.tb10919.x.

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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.

Carlo Agostoni, Prof principal investigator

Azienda Ospedaliera San Paolo

Gian Vincenzo Zuccotti, Prof principal investigator

Azienda Ospedaliera "Luigi Sacco"

Giacomo Biasucci, Dr principal investigator

Ospedale Civile "G. da Saliceto"

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Infant formula (with GOS) in people with Nutritional Safety, run by Heinz Italia SpA at 7 sites in Italy.

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 9 inclusion and 6 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 18 Mar 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 Italy. 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?

The nutritional safety through anthropometric controls. Adverse events: diarrhea, crying, gaseous colics, regurgitation, vomit, skin rashes, fever. (time frame: Anthropometric controls at birth, on enrolment, after 1, 2, 3, 4 months of life and just before starting weaning. Adverse events daily.). 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 NCT00486148, which also lists 21 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 18 Mar 2015.