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

• ClinicalTrials.gov Identifier: NCT04745455
• Recruitment Status: Completed
• First Posted: February 9, 2021
• Last Update Posted: January 25, 2022
• Sponsor: Nutricia Research
• Information provided by (Responsible Party): Nutricia Research

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Gastrointestinal Tolerance	Other: Infant formula containing prebiotics, probiotics and postbiotics	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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.
• Actual Study Start Date: January 22, 2021
• Actual Primary Completion Date: July 12, 2021
• Actual Study Completion Date: July 12, 2021

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Gastrointestinal tolerance [ Time Frame: Baseline ]
   A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
2. Gastrointestinal tolerance [ Time Frame: Day 7 ]
   A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
3. Gastrointestinal tolerance [ Time Frame: Day 14 ]
   A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
4. Gastrointestinal tolerance [ Time Frame: Day 21 ]
   A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
5. 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 Outcome Measures :

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

Other Outcome Measures:

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

Eligibility Criteria

• Ages Eligible for Study: up to 84 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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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Contacts and Locations

Locations

Poland

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

Białystok, Poland, 15-435

Izabela Tarczoń Przylądek Zdrowia Specjalistyczne Poradnie Medyczne

Kraków, Poland, 30-324

NZLA Michalkowice Jarosz i partnerzy Spolka

Siemianowice-Slaskie, Poland, 41-103

Sponsors and Collaborators

Nutricia Research

More Information

• Responsible Party: Nutricia Research
• ClinicalTrials.gov Identifier: NCT04745455
• Other Study ID Numbers: SBB20R&32116
• First Posted: February 9, 2021
• Last Update Posted: January 25, 2022
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No