InfantBAMBINOLNCT00808756

Study on Fermentable Carbohydrates in Healthy Infants

A study testing Fermentable carbohydrates. and Standard infant formula. in people with Infant and Growth, run by University Rovira i Virgili at 2 sites in Spain.

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 project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants. Read more about this study

Who is it for?: Ages 1 day to 1 monthHealthy volunteers can take part
Conditions the study is for: Infant, Growth, Nutrition
What is being tested?: Fermentable carbohydrates. and Standard infant formula.
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 388 participants
Where: 2 sitesSpain
Study dates: Sep 2008to Mar 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 month
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Infants born in Reus and Tarragona area
Healthy
Normal feeding behaviour

Who cannot join

Serious respiratory, neurological, gastrointestinal or metabolic disorders
Infections or other serious diseases that could interfere in normal feeding or growth
Parents or guardians cannot be expected to comply with protocol
Parents or guardians have not command on Catalan or Spanish language

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43201
Hospital Universitari de Tarragona Joan XXIII
Tarragona, Tarragona, 43005

Other trials in Spain

About this study

The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.

Read the detailed description

Breast-fed infants have a lower occurrence of episodes of sickness compared with formula-fed infants, and this has been ascribed to their different flora composition. The purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants. Additionally, other metabolic parameters will be investigated and compared to breast-fed infants.

Conditions: Infant, Growth, Nutrition, Healthy
Being tested: Fermentable carbohydrates., Standard infant formula.
Keywords: Carbohydrates, Infant, Intestine, Faeces, Growth, Diet

What participants receive

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

Fermentable carbohydrates.Dietary supplement
Infant formula enriched with fermentable carbohydrates.
Standard infant formula.Other
Standard infant formula.

Study groups in NCT00808756
Study group	Role	What they receive
1: Intervention	Experimental	This group will be fed a diet enriched with fermentable carbohydrates. Receives: Dietary Supplement: Fermentable carbohydrates.
2: Placebo.	Placebo comparator	The placebo group will be fed a diet without addition of fermentable carbohydrates. This placebo formula will have the same nutritional values than the intervention (energy, proteins, carbohydrates, fat, vitamins \& minerals). Receives: Other: Standard infant formula.
BF	No intervention	The 2 intervention groups will be compared with a breast-fed infants control group.

What is being measured

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

Children well-being and appropriate growth
Measured: up to 4 months

Secondary outcomes (1)

Secondary outcomes will be metabolic parameters.
Measured: Up to 4 months

Timeline

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

Sep 2008Mar 2012

First posted16 Dec 2008 (estimated)
Study startSep 2008
Primary completionSep 2010
Study completionMar 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 InfantStudies 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
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 388 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00808756
Sponsor's protocol ID: BAMBINOL
Acronym: BAMBINOL
Status last verified: Aug 2012
First submitted: 15 Dec 2008
Last updated: 8 Aug 2012
Results posted: No
Data monitoring committee: Yes

Publications

Closa-Monasterolo R, Gispert-Llaurado M, Luque V, Ferre N, Rubio-Torrents C, Zaragoza-Jordana M, Escribano J. Safety and efficacy of inulin and oligofructose supplementation in infant formula: results from a randomized clinical trial. Clin Nutr. 2013 Dec;32(6):918-27. doi: 10.1016/j.clnu.2013.02.009. Epub 2013 Feb 26.
PubMed 23498848

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?

See locations

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All Infant trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on Fermentable Carbohydrates in Healthy Infants
ClinicalTrials.gov ID: NCT00808756
Acronym / sponsor ID: BAMBINOL / BAMBINOL
Conditions: Infant, Growth, Nutrition, Healthy
Keywords: Carbohydrates, Infant, Intestine, Faeces, Growth, Diet
Study type: Interventional
Recruitment status: Completed
Enrolment: 388 participants (actual)
Lead sponsor: University Rovira i VirgiliUniversity, hospital or other
Collaborators: Hospital Universitari Joan XXIII de Tarragona., Hospital Universitari Sant Joan, Institut Investigacio Sanitaria Pere Virgili
Study start: Sep 2008
Primary completion: Sep 2010 (actual)
Study completion: Mar 2012 (actual)
First posted: 16 Dec 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 purpose of this project is to study the effect of fermentable carbohydrates in the nutrition of healthy infants.

Detailed description

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, investigator)
Number of arms: 3

Arm	Type	Receives
1: Intervention	Experimental	Dietary Supplement: Fermentable carbohydrates.This group will be fed a diet enriched with fermentable carbohydrates.
2: Placebo.	Placebo comparator	Other: Standard infant formula.The placebo group will be fed a diet without addition of fermentable carbohydrates. This placebo formula will have the same nutritional values than the intervention (energy, proteins, carbohydrates, fat, vitamins \& minerals).
BF	No intervention	–The 2 intervention groups will be compared with a breast-fed infants control group.

Who may qualify

Ages: 1 day to 1 month
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Infants born in Reus and Tarragona area
Healthy
Normal feeding behaviour

Key exclusion criteria (4 listed)

Serious respiratory, neurological, gastrointestinal or metabolic disorders
Infections or other serious diseases that could interfere in normal feeding or growth
Parents or guardians cannot be expected to comply with protocol
Parents or guardians have not command on Catalan or Spanish language

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
Fermentable carbohydrates.Infant formula enriched with fermentable carbohydrates.	Dietary supplement	1: Intervention
Standard infant formula.Standard infant formula.	Other	2: Placebo.

Primary outcome

Children well-being and appropriate growth
Time frame: up to 4 months

1 secondary outcome

Secondary outcomes will be metabolic parameters.
Time frame: Up to 4 months

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 8 Aug 2012.
Derived from this study: PubMed 23498848Closa-Monasterolo R, Gispert-Llaurado M, Luque V, Ferre N, Rubio-Torrents C, Zaragoza-Jordana M, Escribano J. Safety and efficacy of inulin and oligofructose supplementation in infant formula: results from a randomized clinical trial. Clin Nutr. 2013 Dec;32(6):918-27. doi: 10.1016/j.clnu.2013.02.009. Epub 2013 Feb 26.

Related trials for Infant

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RecruitingObservational study
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Vestibular Dysfunction, Hearing Loss
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
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Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
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RecruitingObservational study
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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.

Ricardo Closa, PhD, Prof principal investigator

University Rovira i Virgili & Hospital Universitari Joan XXIII

Joaquin Escribano, PhD, Prof principal investigator

Universitat Rovira i Virgili. Hospital Universitari Sant Joan de Reus.

Veronica Luque, PhD study director

University Rovira i Virgili

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

Questions about this trial

What is this clinical trial studying?

A study testing Fermentable carbohydrates. and Standard infant formula. in people with Infant and Growth, run by University Rovira i Virgili at 2 sites in Spain.

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 4 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 8 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. 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?

Children well-being and appropriate growth (time frame: up to 4 months). 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 NCT00808756, 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 8 Aug 2012.