NCT07444008Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 22 Feb 2026
- Start date
- 16 Mar 2026
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- NovoNatum Ltd
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07444008
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 16 Mar 2026 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of other probiotic products, antibiotics, enteral antiseptics, antifungal, or antiprotozoal medications.
Other illness
- The child has a congenital pathology or any other conditions/diseases/clinical manifestations that may interfere with participation in the study.
Other
- Use of lactase supplements.
- The child was born preterm (before the 7th month of gestation).
Who the study is looking for
- 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.
Age in the registry: 1 month to 5 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43" Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.