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NCT Number: NCT07444008

Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete

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.

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Key information

Conditions

Infantile Colics Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constipation Dermatitis Dermatitis, Atopic Diarrhea Diarrhea, Infantile Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infantile Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

1 month–5 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Saint Petersburg, 198207, Russia

Location status: Recruiting

Location contact

Sergey Rodygin

CONTACT

[email protected]

+7 (812) 403-03-34

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

BioAmicus Complete

Dietary Supplement

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

Placebo

Dietary Supplement

Sunflower oil

Primary outcomes

  1. Constipation or diarrhea

    Time frame: 28 days

    assessed by changes in stool frequency [number of bowel movements] and perceived ease of defecation. Episodes per day.

  2. Frequency and duration of colic

    Time frame: 28 days

    assessed by changes in the number of colic episodes, number of crying episodes, and average duration of crying. Episodes per day and duration in minutes.

  3. Gastroesophageal reflux

    Time frame: 28 days

    GER, assessed by changes in the number of GER episodes per day

Secondary outcomes

  1. Cutaneous manifestations of food allergy.

    Time frame: 28 days

    Number of patientswithhe presence or absence of clinical manifestations of skin symptoms of food allergy (atopic dermatitis/eczema)

  2. Weight increase

    Time frame: 28 days

    Change in body weight relative to the baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Oleg Tyrsin

CONTACT

[email protected]

+7 985 784 3151

Sponsors and collaborators

Lead sponsor

NovoNatum Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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