A randomized, controlled study to evaluate the safety and tolerance of an infant formula with locust bean gum in infants with regurgitation. (Solar)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
103
Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.
Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics for a period of 8-14 weeks (dependent on infants age at baseline). The intervention last's until the infant's age of 17 weeks.
A.O.U. Ospedali Riuniti di Ancona
Ancona, Italy
Ospedale pediatrico Giovanni XXIII
Bari, Italy
Average stool consistency
The average stool consistency (based on the 4-point Brussels Infant and Toddler Stool Scale \[BITSS\]) of the 8th week of intervention, adjusted for the baseline stool consistency score. Catagories are hard stools, formed stools, loose stools and watery stools. https://bitss-stoolscale.com/ (assessed 31-Jan-19) can be used as a further reference.
Time frame: 8 weeks
To assess the average stool consistency
The average stool consistency based on the BITSS, adjusted for baseline, for every week until the 8th week of intervention and for the week prior to the age of 17 weeks
Time frame: 8 weeks
The average stool frequency
The average stool frequency, adjusted for baseline, for every week until and including the 8th week of intervention and for the week prior to the age of 17 weeks
Time frame: 8 weeks
Incidence of diarrhoea:
1. based on the WHO criteria and derived from the BITSS, for every week (until and including week 8 of intervention, and at the age of 17 weeks) 2. based on investigator's diagnosis of diarrhoea (throughout the entire study)
Time frame: 8 weeks, 17 weeks
IGSQ sum and individual item scores
IGSQ sum and individual item scores, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks
Time frame: 2, 4, 8, 17 weeks
Gut microbiota composition and function
Gut microbiota composition and function (acetate, lactate, pH, calprotectin, ammonium and sIgA) at baseline and at the age of 17 weeks
Time frame: 17 weeks
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Azienda Ospedaliera Universitaria G. Martino
Messina, Italy
Ospedale dei bambini Buzzi
Milan, Italy
Ospedale F. Del Ponte
Varese, Italy
Poliklinika Ginekologiczno-Położnicza Sp. z o.o. Sp. k.
Bialystok, Poland
Osrodek badan Klinicznych IN-VIVO sp. z o.o.
Bydgoszcz, Poland
Gabinet Lekarski
Rzeszów, Poland
NZLA Michalkowice Jarosz
Siemianowice Śląskie, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska sp. z o.o
Tarnów, Poland
...and 6 more locations
Regurgitation
Regurgitation: number of regurgitation episodes per day and the regurgitation volume score, adjusted for baseline, at 2, 4 and 8 weeks of intervention, and at the age of 17 weeks (based on 3-day diaries)
Time frame: 2,4,8,17 weeks