A study to investigate the gastrointestinal tolerance and safety of a new formula containing prebiotics, probiotics and postbiotics.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
31
Infant formula containing prebiotics, probiotics and postbiotics
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 28
Stool consistency
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
Time frame: Baseline
Stool consistency
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
Time frame: Day 7
Stool consistency
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Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
Time frame: Day 14
Stool consistency
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
Time frame: Day 21
Stool consistency
Parent reported daily stool consistency using stool scales with categories 1; watery, 2; loose, 3; formed, 4; hard
Time frame: Day 28
Stool frequency
Parent reported daily number of stools
Time frame: Baseline
Stool frequency
Parent reported daily number of stools
Time frame: Day 7
Stool frequency
Parent reported daily number of stools
Time frame: Day 14
Stool frequency
Parent reported daily number of stools
Time frame: Day 21
Stool frequency
Parent reported daily number of stools
Time frame: Day 28
Incidence, frequency, and severity of (S)AEs, and relatedness to study product of (Serious) Adverse Events.
(S)AE collection
Time frame: Through study completion, an average of one month