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

NCT ID: NCT04745455

Last Updated: 2022-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-22
• Study Completion Date: 2021-07-12

Brief Summary

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

Conditions

Gastrointestinal Tolerance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Infant formula containing prebiotics, probiotics and postbiotics

Intervention Type: OTHER

Infant formula containing prebiotics, probiotics and postbiotics

Interventions

Infant formula containing prebiotics, probiotics and postbiotics

Infant formula containing prebiotics, probiotics and postbiotics

Intervention Type: OTHER

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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• Minimum Eligible Age: 14 Days
• Maximum Eligible Age: 84 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nutricia Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K

Bialystok, , Poland

Izabela Tarczoń Przylądek Zdrowia Specjalistyczne Poradnie Medyczne

Krakow, , Poland

NZLA Michalkowice Jarosz i partnerzy Spolka

Siemianowice Śląskie, , Poland

Countries

Poland

Other Identifiers

SBB20R&32116

Identifier Type: -

Identifier Source: org_study_id