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

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

Official Title
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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.

Conditions
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Gastrointestinal Tolerance

Intervention / Treatment
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* Other: Infant formula containing prebiotics, probiotics and postbiotics


Participation Criteria
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Eligibility Criteria
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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; 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; 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); Infants with previous, current or intended participation in any other clinical study involving investigational or marketed products concomitantly or prior to study. -

Ages Eligible for Study
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Minimum Age: 14 Days
Maximum Age: 84 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cow's milk based infant formula containing prebiotics, probiotics and postbiotics<br> | Other: Infant formula containing prebiotics, probiotics and postbiotics<br>* Infant formula containing prebiotics, probiotics and postbiotics<br>|

What is the study measuring?
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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 |