|- candidate number||9056|
|- NTR Number||NTR2726|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-feb-2011|
|- Secondary IDs||CAX.1.C/A Danone Research|
|- Public Title||Exploratory study to investigate the effects of a new infant formula in healthy term infants during the first 6 months of life.|
|- Scientific Title||Exploratory study to investigate the effects of a new infant formula in healthy term infants during the first 6 months of life.|
|- ACRONYM||COMBI Study|
|- hypothesis||That the combination of two known immunologically active ingredients can effectively modulate the intestinal microbiota and immune system and thereby might reduce the incidence of allergy and infections.|
|- Healt Condition(s) or Problem(s) studied||Healthy full-term infants|
|- Inclusion criteria||1. Healthy term infants (gestational age 37 to 42 weeks);|
2. Birth weight within normal range for gestational age and sex (10th to 90th percentile according to applicable growth charts);
3. Age ≤ 7 days at baseline;
4. For infants to be randomised into one of the formula groups: Infants who are fully formula-fed or have started the transition from breast- to formula-feeding (indicated by the feeding of at least one bottle of infant formula in the past);
5. For infants to be recruited into the breast-fed reference group: Infants who are exclusively breast-fed since birth (never received any infant formula) and with the mother's intention to continue exclusive breast-feeding until the infant's age of at least 4 months;
6. Written informed consent from both parents;
7. Parents' willingness and ability to comply with the protocol requirements.
|- Exclusion criteria||1. Infants whose mothers are known to suffer from hepatitis B, Human Immunodeficiency Virus (HIV) or Group B Streptococcal infection (GBS);|
2. Infants whose mothers have taken antibiotics while breast-feeding;
3. Infants having received antibiotics prior to participation in the study;
4. Current or previous illnesses which could interfere with the study (e.g. prolonged severe diarrhoea);
5. Known congenital diseases or malformations which could interfere with the study (gastrointestinal malformations, congenital immunodeficiency);
6. High risk to develop an atopic disease (at least one parent or sibling with manifest atopic symptoms of hay fever, asthma or atopic dermatitis);
7. Need to feed a special diet other than standard cow's milk-based IF;
8. Study pre-feedings which could interfere with the study, e.g. non-cow's milk-based formulas, HA formulas, probiotic formulas.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||30-nov-2012|
|- Target number of participants||350|
|- Interventions||Duration of intervention: 6 months.
Intervention group 1: Healthy infants receiving a standard cow’s milk-based infant formula containing a combination of two known immunologically active ingredients.
Intervention group 2: Healthy infants receiving a standard cow’s milk-based infant formula containing immunologically active ingredient 1.
Intervention group 3: Healthy infants receiving a standard cow’s milk-based infant formula containing immunologically active ingredient 2.
Control group: Healthy infants receiving a standard cow’s milk-based infant formula with the same composition as the Investigational Formula 1, but without supplementation with active ingredients.
Reference group: Exclusively breast-fed infants.
|- Primary outcome||1. To investigate the effects on the composition and metabolic activity of the intestinal microbiota (e.g. percentage of bifidobacteria and potential pathogens, pH and short-chain fatty acids) and on the immune status (e.g. SIgA) in healthy term infants during the first 6 months of life of:|
A. An IF containing immunologically active ingredient 1 and/or immunologically active ingredient 2 compared to a standard IF;
B. The three investigational formulas compared with each other.
2. To assess intestinal tolerance and safety of an infant formula containing immunologically active ingredient 1 and/or immunologically active ingredient 2;
3. As reference, to assess the composition and metabolic activity of the intestinal microbiota (e.g. percentage of bifidobacteria and potential pathogens, pH and short-chain fatty acids) and on the immune status (e.g. SIgA) in healthy term exclusively breast-fed infants during the first 6 months of life.
|- Secondary outcome||N/A|
|- Timepoints||Time points of the outcome: The whole study will take around 1 year and 1 month.|
1. Visit 1: Screening, randomisation and baseline at 1-7 days of age;
2. Visit 2: 2 months of age;
3. Visit 3: 4 months of age;
4. Visit 4: 6 months of age;
5. Follow-up phone call: 6 months and 2 weeks of age.
|- Trial web site|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||PhD. Jenny Cadée|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. MSc. M.J. Mooren, van der|
|- Sponsor/Initiator ||Danone Research B.V.|
(Source(s) of Monetary or Material Support)
|Nutricia Research - Centre for Specialised Nutrition , Blédina SA|
|- Brief summary||The parents are approached in the first 7 days of their infant’s life to participate in the study if their infant is eligible. The study consists of 4 visits and 1 follow-up phone call. During each visit the infants are examined and a stool sample is collected. Also diaries are filled in by the parents in-between visits. The duration of the study participation for each infant is 25 to 26 weeks, depending on the age at baseline. Then 2 weeks after the end of the intervention period a follow-up phone call takes place to record the current feeding regime and any (serious) adverse events which might have occurred after visit 4. |
|- Main changes (audit trail)||31-3-2014: The first subject was included 1Feb2011 and the last subject was out of the study 2Nov2012.
Danone Research changed names into Nutricia Research. - AB|
|- RECORD||1-feb-2011 - 31-mrt-2014|