Actively Recruiting
Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
Led by NovoNatum Ltd · Updated on 2026-05-11
140
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The child's parents or guardians speak Russian, understand the study, and have signed informed consent
- The child has diarrhea or constipation with colic and/or regurgitation (gastroesophageal reflux)
- The child shows skin symptoms of food allergy
- The child was born at term or preterm but not before the 7th month of gestation
- The child is aged from 1 month to 4 months and 28 days at consent
- The child is fed by breastfeeding, formula, or mixed feeding
- The child has no other health conditions needing a special diet
- Parents or guardians can regularly complete the observation diary
You will not qualify if you...
- The child has a congenital pathology or other conditions that interfere with the study
- Use of lactase supplements
- Use of probiotics, antibiotics, enteral antiseptics, antifungal, or antiprotozoal drugs
- The child was born before the 7th month of gestation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43"
Saint Petersburg, Russia, 198207
Actively Recruiting
Research Team
O
Oleg Tyrsin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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