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Exploratory study to investigate the effects of a new infant formula in healthy term infants during the first 6 months of life.


- candidate number9056
- NTR NumberNTR2726
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-feb-2011
- Secondary IDsCAX.1.C/A Danone Research
- Public TitleExploratory study to investigate the effects of a new infant formula in healthy term infants during the first 6 months of life.
- Scientific TitleExploratory study to investigate the effects of a new infant formula in healthy term infants during the first 6 months of life.
- ACRONYMCOMBI Study
- hypothesisThat 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) studiedHealthy full-term infants
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2011
- planned closingdate30-nov-2012
- Target number of participants350
- InterventionsDuration 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 outcome1. 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 outcomeN/A
- TimepointsTime 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
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESPhD. Jenny Cadée
- CONTACT for SCIENTIFIC QUERIESMD. PhD. MSc. M.J. Mooren, van der
- Sponsor/Initiator Danone Research B.V.
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition , Blédina SA
- PublicationsN/A
- Brief summaryThe 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
- RECORD1-feb-2011 - 31-mrt-2014


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