An Open-label Single-arm Study to Investigate Gastrointestinal Tolerance, Safety, and Acceptability of a New Infant Formula Containing Prebiotics, Probiotics and Postbiotics, in Healthy Term Infants.

Nutricia Research3 sites in 1 country31 target enrollmentJanuary 22, 2021

ConditionsGastrointestinal Tolerance

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastrointestinal Tolerance
Sponsor: Nutricia Research
Enrollment: 31
Locations: 3
Primary Endpoint: Gastrointestinal tolerance
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 22, 2021

End Date

July 12, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Nutricia Research

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Term infants with a gestational age at birth of ≥37 weeks + 0 days and ≤41 weeks + 6 days;
•Singleton, healthy infants as judged by the principle investigator;
•Infants with age at screening ≥2 weeks (14 days) and ≤ 12 weeks (84 days)
•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;
•Written informed consent from the parent(s) and/or legally acceptable representative(s), aged ≥ 18 years.

Exclusion Criteria

•Infants who require to be fed a special diet other than standard cow's milk-based infant formula;
•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;
•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;
•Infants diagnosed with a gastrointestinal infection within 4 weeks prior to screening;
•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;
•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;
•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);
•Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products concomitantly or prior to study.

Outcomes

Primary Outcomes

Gastrointestinal tolerance

Time Frame: Day 28

A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.

Secondary Outcomes

Stool frequency(Day 28)
Stool consistency(Day 28)
Incidence, frequency, and severity of (S)AEs, and relatedness to study product of (Serious) Adverse Events.(Through study completion, an average of one month)