Focus on Healthy Infant Growth.NCT00836771
Infant Formula Supplemented With Probiotic Microorganisms and/or Prebiotic.
A study testing Infant Formula in people with Focus on Healthy Infant Growth., run by Materna Laboratories at 1 site in Israel.
Trial summary
Evaluation the nutritional suitability of a based milk infant formula supplemented with friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to healthy, full term infants compare with an otherwise identical widely used commercially available milk based infant formula and/or breast feed Read more about this study
- Who is it for?
- Ages 1 day to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Focus on Healthy Infant Growth.
- What is being tested?
- Infant Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2009to 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 1 day to 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants of both sexes, born in natural labor .
- Single birth.
- Full term infants (born between the 37th and 42nd week of gestation)
- Infants with birth weight >2500 g.
- Recruitment age will be 0-21 days.
- Infants whose mothers are unable to breast feed or have chosen not to breast feed prior to the study enrollment.
Show all 10Show fewer
- Infants whose parents have agreed to participate in the study up to the age of 9 months..
- Infants whose parents have agreed to remain exclusively on the same product for 16 weeks of age..
- Infants whose parents have signed the informed consent form.
- Infants whose parents are able to understand the protocol requirements and to fill out the infant's diary and agree to completely fill out the parents' questionnaires during the period Of 9 months
Who cannot join
- Twins.
- Premature or low birth weight (< 2500 g).
- Chromosomal abnormalities or congenital malformation.
- Suffering jaundice which require phototherapy.
- Proven or suspected family history of allergy to cow's milk.
- Having been treated with antibiotics or other drugs during the last three days or more prior to the commencement of the study.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Neonatology department, Laniado Hospital- Sanz Medical Center, .
Netanya
About this study
Official title: Evaluation of the Effect of Milk Based Infant Formula Supplemented Either With Probiotic Microorganisms and/or With Prebiotic on the Intestinal Microflora During the First 4 Months of Life of Healthy, Full Term Infants and it's Long Term Effect on Morbidity up to the Age of 9 Months
Evaluation the nutritional suitability of a based milk infant formula supplemented with friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to healthy, full term infants compare with an otherwise identical widely used commercially available milk based infant formula and/or breast feed
- Conditions
- Focus on Healthy Infant Growth.
- Being tested
- Infant Formula
- Keywords
- Infant formula, Probiotic microorganisms, prebiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant FormulaDietary supplement
Also called Materna
| Study group | Role | What they receive |
|---|---|---|
| Materna infant formula 1 | Placebo comparator | milk based infant formula powder Receives: Dietary Supplement: Infant Formula |
| Materna infant formula 2 | Experimental | Probiotic supplemented infant formula Receives: Dietary Supplement: Infant Formula |
| Materna infant formula 3 | Experimental | Prebiotic supplemented infant formula Receives: Dietary Supplement: Infant Formula |
| Materna infant formula 4 | Experimental | Prebiotic+ Probiotic supplemented infant formula Receives: Dietary Supplement: Infant Formula |
| Human milk | Other | Human Milk Receives: Dietary Supplement: Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
Measured: 1 to 120 days of age
Secondary outcomes (2)
Anthropometric
Measured: 1-120 days of age
GI tolerance
Measured: 1-120 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focus on Healthy Infant Growth.Studies 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Materna Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nehama Linder, M.D. Ph.D, Principal investigator, Neonatology department, Rabin Medical center, Petach Tikva. IsraelRaanan Shamir, M.D. Ph.D., Principal investigator, Institute of Gastroenterology Nutrition and Liver Diseases Schneider children medical center, Petach Tikva.Kobi Shiff, M.D., Principal investigator, Neonatology department, Laniado Hospital- Sanz Medical Center, Netanya, Israel.Zvi Weizman, M.D. Ph.D, Principal investigator, Department of Pediatrics, Soroka University Medical Center, Beer-Sheva, Israel.Uri Rubenstein, M.D, Principal investigator, clinic, 1 Yehuda Perach St., Natanya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836771
- Sponsor's protocol ID
- 80801
- Status last verified
- May 2012
- First submitted
- 3 Feb 2009
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Milk Based Infant Formula Supplemented Either With Probiotic Microorganisms and/or With Prebiotic on the Intestinal Microflora During the First 4 Months of Life of Healthy, Full Term Infants and it's Long Term Effect on Morbidity up to the Age of 9 Months
- ClinicalTrials.gov ID
- NCT00836771
- Acronym / sponsor ID
- 80801
- Conditions
- Focus on Healthy Infant Growth.
- Keywords
- Infant formula, Probiotic microorganisms, prebiotic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Materna LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Feb 2009 (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.
Evaluation the nutritional suitability of a based milk infant formula supplemented with friendly bacteria (probiotic microorganisms) and or nutritional fibers (prebiotic) to healthy, full term infants compare with an otherwise identical widely used commercially available milk based infant formula and/or breast feed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Materna infant formula 1 | Placebo comparator | Dietary Supplement: Infant Formulamilk based infant formula powder |
| Materna infant formula 2 | Experimental | Dietary Supplement: Infant FormulaProbiotic supplemented infant formula |
| Materna infant formula 3 | Experimental | Dietary Supplement: Infant FormulaPrebiotic supplemented infant formula |
| Materna infant formula 4 | Experimental | Dietary Supplement: Infant FormulaPrebiotic+ Probiotic supplemented infant formula |
| Human milk | Other | Dietary Supplement: Infant FormulaHuman Milk |
Who may qualify
- Ages
- 1 day to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Healthy term infants of both sexes, born in natural labor .
- Single birth.
- Full term infants (born between the 37th and 42nd week of gestation)
- Infants with birth weight >2500 g.
- Recruitment age will be 0-21 days.
Key exclusion criteria (6 listed)
- Twins.
- Premature or low birth weight (< 2500 g).
- Chromosomal abnormalities or congenital malformation.
- Suffering jaundice which require phototherapy.
- Proven or suspected family history of allergy to cow's milk.
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 FormulaAlso: Materna | Dietary supplement | Human milk, Materna infant formula 1, Materna infant formula 2, Materna infant formula 3, Materna infant formula 4 |
Primary outcome
weight gain
Time frame: 1 to 120 days of age
2 secondary outcomes
Anthropometric
Time frame: 1-120 days of age
GI tolerance
Time frame: 1-120 days of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
Related trials for Focus on Healthy Infant Growth.
Enrolling by invitation
Development of Muscle Function in Prepubertal Children As a Response to Growth and Resistance Training
Focus on Healthy Infants
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.
Nehama Linder, M.D. Ph.D principal investigator
Neonatology department, Rabin Medical center, Petach Tikva. Israel
Raanan Shamir, M.D. Ph.D. principal investigator
Institute of Gastroenterology Nutrition and Liver Diseases Schneider children medical center, Petach Tikva.
Kobi Shiff, M.D. principal investigator
Neonatology department, Laniado Hospital- Sanz Medical Center, Netanya, Israel.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Formula in people with Focus on Healthy Infant Growth., run by Materna Laboratories at 1 site in Israel.
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 10 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: status not confirmed, as of the sponsor's last update on 31 Jul 2013. 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 Israel. 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?
Results are not available in the source record.
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?
weight gain (time frame: 1 to 120 days of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2013.