Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Infantile Colics, Constipation, Infantile Diarrhea, Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT07444008

Run by

NovoNatum Ltd

People needed

140

Starts

2026-03-16

Expected to finish

2026-07-30

Last updated by the study team

2026-05-11

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The child's parents/guardians speak Russian, have been informed about the study's purpose, understand its essence, are aware of their rights, and have signed the informed consent form.
• Diarrhea or constipation accompanied by colic and/or regurgitation (gastroesophageal reflux, GER).
• Cutaneous manifestations of food allergy.
• The child was born at term or preterm, but not before the 7th month of gestation.
• Age at the time of parental informed consent: from 1 month to 4 months and 28 days.
• The child is on breastfeeding, formula feeding, or mixed feeding.
• The child has no other health conditions that would require a specialized diet.
• The parents/guardians are able and willing to regularly complete the proposed observation diary form.

You may not qualify if…

• The child has a congenital pathology or any other conditions/diseases/clinical manifestations that may interfere with participation in the study.
• Use of lactase supplements.
• Use of other probiotic products, antibiotics, enteral antiseptics, antifungal, or antiprotozoal medications.
• The child was born preterm (before the 7th month of gestation).

Where it is running

• St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43" — Saint Petersburg, Russia (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.