This is a randomized, single-blind, placebo-controlled study to evaluate the efficacy of the dietary supplement BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria) in managing functional gastrointestinal disorders and cutaneous symptoms of food allergy in infants during the first months of life. The aim of the study is to assess clinical effects of BioAmicus Complete drops on the symptoms of infantile colic, constipation, diarrhea, gastroesophageal reflux, atopic dermatitis/eczema in full-term newborns during the first months of life. A prospective study comparing two treatment groups: Group 1 (treatment group) - 70 infants. Group 2 (control group) - 70 infants, placebo. The study drug will be taken in 1 time per day within 25 days. Allowed symptomatic therapy includes defoamers (simethicone-based preparations), carminative preparations (dill water (fenhel)), etc.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria)
Sunflower oil
City outpatient # 43
Saint Petersburg, Russia
Constipation or diarrhea
assessed by changes in stool frequency \[number of bowel movements\] and perceived ease of defecation. Episodes per day.
Time frame: 29 days
Frequency and duration of colic
assessed by changes in the number of colic episodes, number of crying episodes, and average duration of crying. Episodes per day and duration in minutes.
Time frame: 29 days
Gastroesophageal reflux
GER, assessed by changes in the number of GER episodes per day
Time frame: 29 days
Cutaneous manifestations of food allergy.
Time frame: 29 days
Weight increase
Time frame: 29 days
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