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

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.

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

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Tolerance
• Intervention / Treatment: Other: Infant formula containing prebiotics, probiotics and postbiotics

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Białystok, Poland, 15-435
    • Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K
  • Kraków, Poland, 30-324
    • Izabela Tarczoń Przylądek Zdrowia Specjalistyczne Poradnie Medyczne
  • Siemianowice-Slaskie, Poland, 41-103
    • NZLA Michalkowice Jarosz i partnerzy Spolka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 2 months (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

   -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Cow's milk based infant formula containing prebiotics, probiotics and postbiotics	Other: Infant formula containing prebiotics, probiotics and postbiotics; Infant formula containing prebiotics, probiotics and postbiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gastrointestinal tolerance	A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.	Baseline
Gastrointestinal tolerance	A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.	Day 7
Gastrointestinal tolerance	A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.	Day 14
Gastrointestinal tolerance	A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.	Day 21
Gastrointestinal tolerance	A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stool consistency	Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard	Baseline
Stool consistency	Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard	Day 7
Stool consistency	Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard	Day 14
Stool consistency	Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard	Day 21
Stool consistency	Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard	Day 28
Stool frequency	Parent reported daily number of stools	Baseline
Stool frequency	Parent reported daily number of stools	Day 7
Stool frequency	Parent reported daily number of stools	Day 14
Stool frequency	Parent reported daily number of stools	Day 21
Stool frequency	Parent reported daily number of stools	Day 28
Incidence, frequency, and severity of (S)AEs, and relatedness to study product of (Serious) Adverse Events.	(S)AE collection	Through study completion, an average of one month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well being questionnaire	A parent reported 3-item questionnaire with individual scores from 1-5 (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree)	Baseline
Well being questionnaire	A parent reported 3-item questionnaire with individual scores from 1-5 (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree)	Day 28
Study product appreciation questionnaire;	A parent reported evaluation of product characteristics with a categorical rating scale and open questions	Day 7
Study product appreciation questionnaire;	A parent reported evaluation of product characteristics with a categorical rating scale and open questions	Day 28

Collaborators and Investigators

• Sponsor: Nutricia Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 22, 2021
• Primary Completion (ACTUAL): July 12, 2021
• Study Completion (ACTUAL): July 12, 2021

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (ACTUAL): February 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SBB20R&32116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No