RecruitingNot ApplicableNCT07444008

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


Sponsor

NovoNatum Ltd

Enrollment

140 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 MonthMax Age: 5 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying BioAmicus Complete and Placebo for people with atopic dermatitis, constipation, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DIETARY_SUPPLEMENTBioAmicus Complete

BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria)

DIETARY_SUPPLEMENTPlacebo

Sunflower oil


Locations(1)

St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43"

Saint Petersburg, Russia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07444008


Related Trials