Formula Feeding of Healthy Full Term InfantsNCT01197365

Safety and Efficacy of an Infant Formula Supplemented With Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

A study testing Infant formula with GOS, beta-palmitate, acidified milk and Standard infant formula without functional ingredients in people with Formula Feeding of Healthy Full Term Infants, run by Heinz Italia SpA at 1 site 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 galacto-oligosaccharides (GOS), beta-palmitate and acidified milk in improving the gastrointestinal health and immune response in healthy term infants. Read more about this study

Who is it for?: Ages Up to 21 days
Conditions the study is for: Formula Feeding of Healthy Full Term Infants
What is being tested?: Infant formula with GOS, beta-palmitate, acidified milk and Standard infant formula without functional ingredients
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 148 participants
Where: 1 siteItaly
Study dates: Aug 2010to Dec 2014
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 21 days
All sexes
No healthy volunteers
Child

Who may be able to join

Infants of both sexes born to natural or cesarean delivery
Gestational age between 37 and 42 completed weeks
Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts
Single birth
Caucasian parents
Infants being exclusively formula-fed by the 21st day of life

Who cannot join

Infants with genetic and/or congenital diseases
Infants receiving antibiotic therapy
Infants with neonatal diseases requiring hospitalisation for longer than 7 days
Infants at risk for atopy and/or having familial history for atopy
Mothers with metabolic or chronic diseases
Infant selected for another clinical study
Parents refusing to sign a written informed consent

Trial locations and contacts

1 site in 1 country.

Italy1 site

Fondazione Irccs Policlinico "San Matteo" - Struttura Complessa Di Neonatologia, Patologia Neonatale E Terapia Intensiva
Pavia, PV, 27100

Other trials in Italy

About this study

Official title: Double-blind Randomized Controlled Study for the Evaluation of Nutritional Outcomes of a Cow's Milk Based Infant Formula Containing Galacto-oligosaccharides, Beta-palmitate and Acidified Milk

Read the detailed description

Infant formulae are the only alternatives to breast milk for infants when, for whatever reason, human milk becomes unavailable.

New-generation infant formulae contain functional ingredients able to mimic some benefits of human milk.

The study formula is supplemented with galacto-oligosaccharides, which favor intestinal positive microflora growth, beta-palmitate, enhancing fat and calcium absorption and softer stool formation, and acidified milk which contributes to immune system maturation.

The aim of this study is to verify the safety of the study formula in healthy term infants and to deepen the efficacy of the functional ingredient blend in term of prebiotic effect, gastrointestinal tolerance and immune response improvement.

Conditions: Formula Feeding of Healthy Full Term Infants
Being tested: Infant formula with GOS, beta-palmitate, acidified milk, Standard infant formula without functional ingredients
Keywords: Acidified milk, Beta-palmitate, Bifidobacteria, Infant formula, Galacto-oligosaccharides, Growth, Infants, Prebiotics

What participants receive

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

Infant formula with GOS, beta-palmitate, acidified milkOther
Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk.
Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae
Standard infant formula without functional ingredientsOther
Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients

Study groups in NCT01197365
Study group	Role	What they receive
STUDY GROUP	Experimental	Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae Receives: Other: Infant formula with GOS, beta-palmitate, acidified milk
CONTROL GROUP	Other	Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients Receives: Other: Standard infant formula without functional ingredients

What is being measured

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

The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms
Anthropometric parameters: body weight, recumbent length and head circumference change. Gastrointestinal symptoms: diarrhea, constipation, stool frequency and consistency, bowel cramps, abdominal distension, intestinal gas.
Measured: Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary.

Secondary outcomes (2)

Immune-modulatory activity
Quantification of salivary IgA
Measured: At enrolment, after 60 and 135 days of life
Prebiotic effect
Microbiological analysis of feces
Measured: At enrolment and after 135 days of life

Timeline

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

Aug 2010Dec 2014

First posted9 Sep 2010 (estimated)
Study startAug 2010
Primary completionMar 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Formula Feeding of Healthy Full Term InfantsStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 148 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01197365
Sponsor's protocol ID: PLA-LENI-09
Status last verified: Feb 2015
First submitted: 7 Sep 2010
Last updated: 4 Feb 2015
Results posted: No
Data monitoring committee: No

Publications

Aggett PJ, Agostini C, Goulet O, Hernell O, Koletzko B, Lafeber HL, Michaelsen KF, Rigo J, Weaver LT; European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition. The nutritional and safety assessment of breast milk substitutes and other dietary products for infants: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2001 Mar;32(3):256-8. doi: 10.1097/00005176-200103000-00004. No abstract available.
PubMed 11345171
Carver JD. Advances in nutritional modifications of infant formulas. Am J Clin Nutr. 2003 Jun;77(6):1550S-1554S. doi: 10.1093/ajcn/77.6.1550S.
PubMed 12812153
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
Brunser O, Araya M, Espinoza J, Guesry PR, Secretin MC, Pacheco I. Effect of an acidified milk on diarrhoea and the carrier state in infants of low socio-economic stratum. Acta Paediatr Scand. 1989 Mar;78(2):259-64. doi: 10.1111/j.1651-2227.1989.tb11066.x.
PubMed 2929349
Mullie C, Yazourh A, Thibault H, Odou MF, Singer E, Kalach N, Kremp O, Romond MB. Increased poliovirus-specific intestinal antibody response coincides with promotion of Bifidobacterium longum-infantis and Bifidobacterium breve in infants: a randomized, double-blind, placebo-controlled trial. Pediatr Res. 2004 Nov;56(5):791-5. doi: 10.1203/01.PDR.0000141955.47550.A0. Epub 2004 Sep 3.
PubMed 15347767
Thibault H, Aubert-Jacquin C, Goulet O. Effects of long-term consumption of a fermented infant formula (with Bifidobacterium breve c50 and Streptococcus thermophilus 065) on acute diarrhea in healthy infants. J Pediatr Gastroenterol Nutr. 2004 Aug;39(2):147-52. doi: 10.1097/00005176-200408000-00004.
PubMed 15269618
Lucas A, St James-Roberts I. Crying, fussing and colic behaviour in breast- and bottle-fed infants. Early Hum Dev. 1998 Nov;53(1):9-18. doi: 10.1016/s0378-3782(98)00032-2.
PubMed 10193923
Quinlan PT, Lockton S, Irwin J, Lucas AL. The relationship between stool hardness and stool composition in breast- and formula-fed infants. J Pediatr Gastroenterol Nutr. 1995 Jan;20(1):81-90. doi: 10.1097/00005176-199501000-00014.
PubMed 7884622
Billeaud C, Guillet J, Sandler B. Gastric emptying in infants with or without gastro-oesophageal reflux according to the type of milk. Eur J Clin Nutr. 1990 Aug;44(8):577-83.
PubMed 2209513
Carnielli VP, Luijendijk IH, van Goudoever JB, Sulkers EJ, Boerlage AA, Degenhart HJ, Sauer PJ. Feeding premature newborn infants palmitic acid in amounts and stereoisomeric position similar to that of human milk: effects on fat and mineral balance. Am J Clin Nutr. 1995 May;61(5):1037-42. doi: 10.1093/ajcn/61.4.1037.
PubMed 7733025
Carnielli VP, Luijendijk IH, van Beek RH, Boerma GJ, Degenhart HJ, Sauer PJ. Effect of dietary triacylglycerol fatty acid positional distribution on plasma lipid classes and their fatty acid composition in preterm infants. Am J Clin Nutr. 1995 Oct;62(4):776-81. doi: 10.1093/ajcn/62.4.776.
PubMed 7572708
Carnielli VP, Luijendijk IH, Van Goudoever JB, Sulkers EJ, Boerlage AA, Degenhart HJ, Sauer PJ. Structural position and amount of palmitic acid in infant formulas: effects on fat, fatty acid, and mineral balance. J Pediatr Gastroenterol Nutr. 1996 Dec;23(5):553-60. doi: 10.1097/00005176-199612000-00007.
PubMed 8985844
Lucas A, Quinlan P, Abrams S, Ryan S, Meah S, Lucas PJ. Randomised controlled trial of a synthetic triglyceride milk formula for preterm infants. Arch Dis Child Fetal Neonatal Ed. 1997 Nov;77(3):F178-84. doi: 10.1136/fn.77.3.f178.
PubMed 9462186
Kennedy K, Fewtrell MS, Morley R, Abbott R, Quinlan PT, Wells JC, Bindels JG, Lucas A. Double-blind, randomized trial of a synthetic triacylglycerol in formula-fed term infants: effects on stool biochemistry, stool characteristics, and bone mineralization. Am J Clin Nutr. 1999 Nov;70(5):920-7. doi: 10.1093/ajcn/70.5.920.
PubMed 10539755
Lopez-Lopez A, Castellote-Bargallo AI, Campoy-Folgoso C, Rivero-Urgel M, Tormo-Carnice R, Infante-Pina D, Lopez-Sabater MC. The influence of dietary palmitic acid triacylglyceride position on the fatty acid, calcium and magnesium contents of at term newborn faeces. Early Hum Dev. 2001 Nov;65 Suppl:S83-94. doi: 10.1016/s0378-3782(01)00210-9.
PubMed 11755039

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind Randomized Controlled Study for the Evaluation of Nutritional Outcomes of a Cow's Milk Based Infant Formula Containing Galacto-oligosaccharides, Beta-palmitate and Acidified Milk
ClinicalTrials.gov ID: NCT01197365
Acronym / sponsor ID: PLA-LENI-09
Conditions: Formula Feeding of Healthy Full Term Infants
Keywords: Acidified milk, Beta-palmitate, Bifidobacteria, Infant formula, Galacto-oligosaccharides, Growth, Infants, Prebiotics
Study type: Interventional
Recruitment status: Completed
Enrolment: 148 participants (actual)
Lead sponsor: Heinz Italia SpAIndustry (pharma, biotech, devices)
Collaborators: Fondazione IRCCS Policlinico San Matteo di Pavia, Centro di Immunità e Nutrizione - Università degli Studi di Pavia (Prof.ssa Annamaria Castellazzi), Advanced Analytical Technologies
Study start: Aug 2010
Primary completion: Mar 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 9 Sep 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.

Detailed description

Infant formulae are the only alternatives to breast milk for infants when, for whatever reason, human milk becomes unavailable.

New-generation infant formulae contain functional ingredients able to mimic some benefits of human milk.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
STUDY GROUP	Experimental	Other: Infant formula with GOS, beta-palmitate, acidified milkInfant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae
CONTROL GROUP	Other	Other: Standard infant formula without functional ingredientsStandard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients

Who may qualify

Ages: Up to 21 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Infants of both sexes born to natural or cesarean delivery
Gestational age between 37 and 42 completed weeks
Birth weight between 10th and 90th percentile of birth weight for gestational age, according to the North-Italian growth charts
Single birth
Caucasian parents

Key exclusion criteria (7 listed)

Infants with genetic and/or congenital diseases
Infants receiving antibiotic therapy
Infants with neonatal diseases requiring hospitalisation for longer than 7 days
Infants at risk for atopy and/or having familial history for atopy
Mothers with metabolic or chronic diseases

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, beta-palmitate, acidified milkInfant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk. Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae	Other	STUDY GROUP
Standard infant formula without functional ingredientsStandard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients	Other	CONTROL GROUP

Primary outcome

The nutritional safety of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms
Time frame: Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary.
Anthropometric parameters: body weight, recumbent length and head circumference change. Gastrointestinal symptoms: diarrhea, constipation, stool frequency and consistency, bowel cramps, abdominal distension, intestinal gas.

2 secondary outcomes

Immune-modulatory activity
Time frame: At enrolment, after 60 and 135 days of life
Prebiotic effect
Time frame: At enrolment and after 135 days 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 4 Feb 2015.
Background: PubMed 11345171Aggett PJ, Agostini C, Goulet O, Hernell O, Koletzko B, Lafeber HL, Michaelsen KF, Rigo J, Weaver LT; European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) Committee on Nutrition. The nutritional and safety assessment of breast milk substitutes and other dietary products for infants: a commentary by the ESPGHAN Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2001 Mar;32(3):256-8. doi: 10.1097/00005176-200103000-00004. No abstract available.
Background: PubMed 12812153Carver JD. Advances in nutritional modifications of infant formulas. Am J Clin Nutr. 2003 Jun;77(6):1550S-1554S. doi: 10.1093/ajcn/77.6.1550S.
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 2929349Brunser O, Araya M, Espinoza J, Guesry PR, Secretin MC, Pacheco I. Effect of an acidified milk on diarrhoea and the carrier state in infants of low socio-economic stratum. Acta Paediatr Scand. 1989 Mar;78(2):259-64. doi: 10.1111/j.1651-2227.1989.tb11066.x.
Background: PubMed 15347767Mullie C, Yazourh A, Thibault H, Odou MF, Singer E, Kalach N, Kremp O, Romond MB. Increased poliovirus-specific intestinal antibody response coincides with promotion of Bifidobacterium longum-infantis and Bifidobacterium breve in infants: a randomized, double-blind, placebo-controlled trial. Pediatr Res. 2004 Nov;56(5):791-5. doi: 10.1203/01.PDR.0000141955.47550.A0. Epub 2004 Sep 3.
Background: PubMed 15269618Thibault H, Aubert-Jacquin C, Goulet O. Effects of long-term consumption of a fermented infant formula (with Bifidobacterium breve c50 and Streptococcus thermophilus 065) on acute diarrhea in healthy infants. J Pediatr Gastroenterol Nutr. 2004 Aug;39(2):147-52. doi: 10.1097/00005176-200408000-00004.
Background: PubMed 10193923Lucas A, St James-Roberts I. Crying, fussing and colic behaviour in breast- and bottle-fed infants. Early Hum Dev. 1998 Nov;53(1):9-18. doi: 10.1016/s0378-3782(98)00032-2.
Background: PubMed 7884622Quinlan PT, Lockton S, Irwin J, Lucas AL. The relationship between stool hardness and stool composition in breast- and formula-fed infants. J Pediatr Gastroenterol Nutr. 1995 Jan;20(1):81-90. doi: 10.1097/00005176-199501000-00014.
Background: PubMed 2209513Billeaud C, Guillet J, Sandler B. Gastric emptying in infants with or without gastro-oesophageal reflux according to the type of milk. Eur J Clin Nutr. 1990 Aug;44(8):577-83.
Background: PubMed 7733025Carnielli VP, Luijendijk IH, van Goudoever JB, Sulkers EJ, Boerlage AA, Degenhart HJ, Sauer PJ. Feeding premature newborn infants palmitic acid in amounts and stereoisomeric position similar to that of human milk: effects on fat and mineral balance. Am J Clin Nutr. 1995 May;61(5):1037-42. doi: 10.1093/ajcn/61.4.1037.
Background: PubMed 7572708Carnielli VP, Luijendijk IH, van Beek RH, Boerma GJ, Degenhart HJ, Sauer PJ. Effect of dietary triacylglycerol fatty acid positional distribution on plasma lipid classes and their fatty acid composition in preterm infants. Am J Clin Nutr. 1995 Oct;62(4):776-81. doi: 10.1093/ajcn/62.4.776.
Background: PubMed 8985844Carnielli VP, Luijendijk IH, Van Goudoever JB, Sulkers EJ, Boerlage AA, Degenhart HJ, Sauer PJ. Structural position and amount of palmitic acid in infant formulas: effects on fat, fatty acid, and mineral balance. J Pediatr Gastroenterol Nutr. 1996 Dec;23(5):553-60. doi: 10.1097/00005176-199612000-00007.

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.

Mauro Stronati, Prof. principal investigator

FONDAZIONE IRCCS POLICLINICO "SAN MATTEO" - STRUTTURA COMPLESSA DI NEONATOLOGIA, PATOLOGIA NEONATALE E TERAPIA INTENSIVA

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

Questions about this trial

What is this clinical trial studying?

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 7 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 4 Feb 2015. 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 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 of the study formula is evaluated through measure of anthropometric parameters and record of gastrointestinal symptoms (time frame: Anthropometric parameters: at birth, at enrolment, after 60 and 135 days of life. Gastrointestinal symptoms: recorded daily in the infant's diary.). 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 NCT01197365, which also lists 26 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 4 Feb 2015.