Condition: Infantile Colics · Constipation · Infantile Diarrhea · Sponsor: NovoNatum Ltd
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.
This description comes directly from the study's public registry record.
Oleg Tyrsin · +7 985 784 3151 · vb@novonatum.com
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| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43" | Saint Petersburg, Russia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07444008