NCT00836771

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 31, 2013

Status Verified

May 1, 2012

Enrollment Period

4.5 years

First QC Date

February 3, 2009

Last Update Submit

July 30, 2013

Conditions

Focus on Healthy Infant Growth.

Keywords

Infant formulaProbiotic microorganismsprebiotic

Outcome Measures

Primary Outcomes (1)

  • weight gain

    1 to 120 days of age

Secondary Outcomes (2)

  • Anthropometric

    1-120 days of age

  • GI tolerance

    1-120 days of age

Other Outcomes (1)

  • Influence on the microbial content of the stool

    3 - 4 times: 1-16 d, 4 w 16 w and 36 w

Study Arms (5)

Materna infant formula 1

PLACEBO COMPARATOR

milk based infant formula powder

Dietary Supplement: Infant Formula

Materna infant formula 2

EXPERIMENTAL

Probiotic supplemented infant formula

Dietary Supplement: Infant Formula

Materna infant formula 3

EXPERIMENTAL

Prebiotic supplemented infant formula

Dietary Supplement: Infant Formula

Materna infant formula 4

EXPERIMENTAL

Prebiotic+ Probiotic supplemented infant formula

Dietary Supplement: Infant Formula

Human milk

OTHER

Human Milk

Dietary Supplement: Infant Formula

Interventions

Infant FormulaDIETARY_SUPPLEMENT
Also known as: Materna
Human milkMaterna infant formula 1Materna infant formula 2Materna infant formula 3Materna infant formula 4

Eligibility Criteria

Age1 Day - 21 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatology department, Laniado Hospital- Sanz Medical Center, .

Netanya, Israel

Location

MeSH Terms

Interventions

Infant Formula

Intervention Hierarchy (Ancestors)

Milk SubstitutesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood, FormulatedFoods, SpecializedFoodInfant FoodFood and Beverages

Study Officials

  • Nehama Linder, M.D. Ph.D

    Neonatology department, Rabin Medical center, Petach Tikva. Israel

    PRINCIPAL INVESTIGATOR

  • Raanan Shamir, M.D. Ph.D.

    Institute of Gastroenterology Nutrition and Liver Diseases Schneider children medical center, Petach Tikva.

    PRINCIPAL INVESTIGATOR

  • Kobi Shiff, M.D.

    Neonatology department, Laniado Hospital- Sanz Medical Center, Netanya, Israel.

    PRINCIPAL INVESTIGATOR

  • Zvi Weizman, M.D. Ph.D

    Department of Pediatrics, Soroka University Medical Center, Beer-Sheva, Israel.

    PRINCIPAL INVESTIGATOR

  • Uri Rubenstein, M.D

    clinic, 1 Yehuda Perach St., Natanya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2014

Study Completion

December 1, 2014

Last Updated

July 31, 2013

Record last verified: 2012-05

Locations

IL(1)