TREE: Gastrointestinal Tolerance and Safety of an Infant Formula Containing Prebiotics, Probiotics and Postbiotics.
Study Details
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Gastrointestinal tolerance [Baseline]
A 13-item questionnaire where each item is scored on a scale of 1 to 5 with higher values indicating greater GI distress.
- Gastrointestinal tolerance [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.
- Gastrointestinal tolerance [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.
- Gastrointestinal tolerance [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.
- Gastrointestinal tolerance [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
- Stool consistency [Baseline]
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
- Stool consistency [Day 7]
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
- Stool consistency [Day 14]
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
- Stool consistency [Day 21]
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
- Stool consistency [Day 28]
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
- Stool frequency [Baseline]
Parent reported daily number of stools
- Stool frequency [Day 7]
Parent reported daily number of stools
- Stool frequency [Day 14]
Parent reported daily number of stools
- Stool frequency [Day 21]
Parent reported daily number of stools
- Stool frequency [Day 28]
Parent reported daily number of stools
- Incidence, frequency, and severity of (S)AEs, and relatedness to study product of (Serious) Adverse Events. [Through study completion, an average of one month]
(S)AE collection
Other Outcome Measures
- Well being questionnaire [Baseline]
A parent reported 3-item questionnaire with individual scores from 1-5 (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree)
- Well being questionnaire [Day 28]
A parent reported 3-item questionnaire with individual scores from 1-5 (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree)
- Study product appreciation questionnaire; [Day 7]
A parent reported evaluation of product characteristics with a categorical rating scale and open questions
- Study product appreciation questionnaire; [Day 28]
A parent reported evaluation of product characteristics with a categorical rating scale and open questions
Eligibility Criteria
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;
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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;
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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);
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Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products concomitantly or prior to study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Poliklinika Ginekologiczno-Poloznicza Sp. Z.O.O Sp.K | Białystok | Poland | 15-435 | |
| 2 | Izabela Tarczoń Przylądek Zdrowia Specjalistyczne Poradnie Medyczne | Kraków | Poland | 30-324 | |
| 3 | NZLA Michalkowice Jarosz i partnerzy Spolka | Siemianowice-Slaskie | Poland | 41-103 |
Sponsors and Collaborators
- Nutricia Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SBB20R&32116