Focus on Healthy Infant Growth. Clinical Trial
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
| Verified date | May 2012 |
| Source | Materna Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Ministry of Health |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 270 |
| Est. completion date | December 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A to 21 Days |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Neonatology department, Laniado Hospital- Sanz Medical Center, . | Netanya, |
| Lead Sponsor | Collaborator |
|---|---|
| Materna Laboratories |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Influence on the microbial content of the stool | Stool were collected to analyze the microbial content of certain bacteria upon enrollment and at the age of 4, 16. and 36 w Stool were collected and delivery to the lab in coolers within 12 h | 3 - 4 times: 1-16 d, 4 w 16 w and 36 w | No |
| Primary | weight gain | 1 to 120 days of age | Yes | |
| Secondary | Anthropometric | 1-120 days of age | Yes | |
| Secondary | GI tolerance | 1-120 days of age | Yes |