Gastro-intestinal Infections Clinical Trial
Official title:
Effect of Starter Formula With Synbiotics on Prevention of Gastro-intestinal Infections and All Infections With Fever in Full Term Infants
The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.
| Status | Completed |
| Enrollment | 477 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A to 12 Months |
| Eligibility |
Inclusion Criteria: - Healthy newborn infant - Full term infant (= 37 weeks gestation; = 42 weeks gestation) - Age of infant is = 13 days at the time of enrollment - Birth weight = 2500g and = 4500g - For the FF groups: The infant's mother has elected not to breastfeed - For the BF group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age - Having obtained his/her legal representative's informed consent Exclusion Criteria: - Congenital illness or malformation that may affect normal growth (especially immunodeficiencies) - Significant pre-natal and/or post-natal diseases - Perinatal antibiotic or infants on antibiotics at the time of inclusion - Infants whose mother has had an acute infection during the last month of pregnancy - Re-hospitalisation for more than 2 days in the first 14 days of life (exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study) - Receiving infant formula containing probiotics and/or prebiotics at the time of enrollment - Newborn whose parents / caregivers cannot be expected to comply with treatment - Newborn currently participating in another interventional clinical trial |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital de la Croix Rousse, Service de réanimation néonatale | Lyon | |
| France | Hôpital Arnaud de Villeneuve, Service de pédiatrie 2 | Montpellier | |
| France | Maternité régionale de Nancy, Service de Néonatologie | Nancy | |
| Germany | Charité Campus Virchow-Klinikum, Klinik für Geburtsmedizin | Berlin | |
| Germany | Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde und Jugendmedizin | Giessen | |
| Germany | Klinikum Ernest von Bergmann, Klinik für Kinder- und Jugendmedizin | Potsdam | |
| Netherlands | Vrije Universiteit Medisch Centrum, Afdeling Kindergeneeskunde | Amsterdam |
| Lead Sponsor | Collaborator |
|---|---|
| Nestlé |
France, Germany, Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diarrhea and all infections with fever | Mean event rate of diarrhea and all infections with fever per child over 6 months and 1 year | over 6 months and 1 year | No |
| Secondary | Morbidity | Frequency of episodes of morbidity (adverse events), especially mean event rate of respiratory illnesses per child over 6 months and 1 year | over 6 months and 1 year | Yes |
| Secondary | Anthropometry | Anthropometry (weight (kg), length (cm), head circumference (cm) and skin fold) | until 1 year | No |
| Secondary | Digestive tolerance | Digestive tolerance (stool characteristics and frequency, vomiting, regurgitation, frequency of colic) | until 1 year | No |
| Secondary | Stool characteristics | Stool bacterial populations (Bifidobacteria, Lactobacilli Species, Clostridium, Bacteroides, Staphylococci epidermitis, presence or absence of B. lactis) Stool pH Stool and saliva S.IgA Stool Alpha 1-antitrypsine as infection/inflammation marker |
at 3 and 6 months | No |