Gastrointestinal Tolerance and Safety of an Infant Formula Containing Prebiotics, Probiotics and Postbiotics. (TREE)

Nutricia

Status: Completed

Conditions: Gastrointestinal Tolerance

Treatments: Other: Infant formula containing prebiotics, probiotics and postbiotics

Study type: Interventional

Funder types: Industry

Identifiers

NCT04745455

SBB20R&32116

Details and patient eligibility

About

A study to investigate the gastrointestinal tolerance and safety of a new formula containing prebiotics, probiotics and postbiotics.

Enrollment: 31 patients

Sex: All

Ages: 14 to 84 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days;
2. Singleton, healthy infants as judged by the principle investigator;
3. Infants with age at screening ≥2 weeks (14 days) and ≤ 12 weeks (84 days)
4. Infants who are fully formula fed for at least 1 week prior to screening and whose parents have autonomously decided to fully formula feed, i.e. not to breastfeed or have ended breastfeeding, and who are intending to fully formula feed;
5. Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.

Exclusion criteria

1. Infants who require to be fed a special diet other than standard cow's milk-based infant formula;

2. Infants known to have or suspected to have cow's milk protein allergy, lactose intolerance, or galactosaemia including history of any other allergic manifestations or known allergy to any of the study product ingredients;

3. Infants with known or suspected congenital diseases or malformations which could interfere with the study or its outcome parameters, such as but not limited to: GI malformations, congenital metabolic disorders, severe congenital cardiac disorders, immunodeficiency or major surgery, as per the clinical judgment of the Investigator;

4. Infants diagnosed with a gastrointestinal infection within 4 weeks prior to screening;

5. Infants with current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters (e.g. diarrhea requiring treatment, constipation requiring treatment, regurgitation requiring treatment, dental/medical procedures which may impact oral feeding), as per the clinical judgment of the Investigator;

6. Received any of the following products/medication prior to screening: systemic antibiotics, prokinetics, proton pump inhibitors, prebiotic supplements, probiotic supplements, complementary feeding/weaning within 4 weeks prior to screening;

7. Incapability of infants' parents to comply with study protocol as per the judgment of the Investigator (e.g. fluency in local language, access to laptop/smartphone devices and internet connection required for data collection);

8. Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products concomitantly or prior to study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Cow's milk based infant formula containing prebiotics, probiotics and postbiotics

Other group

Treatment:

Other: Infant formula containing prebiotics, probiotics and postbiotics