NCT07444008

Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: NovoNatum Ltd · Industry
• Sex: All
• Age: 1 Month – 5 Months
• Healthy volunteers: Not accepted

Summary

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

• Infantile Colics
• Constipation
• Infantile Diarrhea
• Atopic Dermatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	BioAmicus Complete	BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria)
DIETARY_SUPPLEMENT	Placebo	Sunflower oil

Timeline

• Start date: 2026-02-26
• Primary completion: 2026-05-30
• Completion: 2026-06-30
• First posted: 2026-03-02
• Last updated: 2026-03-03

Locations

1 site across 1 country: Russia