Clinical trial NCT04745455: Gastrointestinal Tolerance and Safety of an Infant Formula Containing Prebiotics, Probiotics and Postbiotics.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Nutricia Research
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 31
Sex: ALL
Minimum age (years): 14
Maximum age (years): 84
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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.

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Primary outcomes:
measure: Gastrointestinal tolerance
timeFrame: Baseline
measure: Gastrointestinal tolerance
timeFrame: Day 7
measure: Gastrointestinal tolerance
timeFrame: Day 14
measure: Gastrointestinal tolerance
timeFrame: Day 21
measure: Gastrointestinal tolerance
timeFrame: Day 28
Secondary outcomes:
measure: Stool consistency
timeFrame: Baseline
measure: Stool consistency
timeFrame: Day 7
measure: Stool consistency
timeFrame: Day 14
measure: Stool consistency
timeFrame: Day 21
measure: Stool consistency
timeFrame: Day 28
measure: Stool frequency
timeFrame: Baseline
measure: Stool frequency
timeFrame: Day 7
measure: Stool frequency
timeFrame: Day 14
measure: Stool frequency
timeFrame: Day 21
measure: Stool frequency
timeFrame: Day 28
measure: Incidence, frequency, and severity of (S)AEs, and relatedness to study product of (Serious) Adverse Events.
timeFrame: Through study completion, an average of one month
Other outcomes:
measure: Well being questionnaire
timeFrame: Baseline
measure: Well being questionnaire
timeFrame: Day 28
measure: Study product appreciation questionnaire;
timeFrame: Day 7
measure: Study product appreciation questionnaire;
timeFrame: Day 28
Locations:
city: Białystok
country: Poland
facility: Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K
city: Kraków
country: Poland
facility: Izabela Tarczoń Przylądek Zdrowia Specjalistyczne Poradnie Medyczne
city: Siemianowice-Slaskie
country: Poland
facility: NZLA Michalkowice Jarosz i partnerzy Spolka
Study officials:
References: