Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete

NCT07444008 | Recruiting

• 1 other identifier: BioAmicus-002
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Constipation or diarrhea

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

  28 days

• Frequency and duration of colic

  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.

  28 days

• Gastroesophageal reflux

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

  28 days

Secondary Outcomes (2)

• Cutaneous manifestations of food allergy.

  28 days

• Weight increase

  28 days

Study Arms (2)

Bioamicus Complete

EXPERIMENTAL

BioAmicus Complete drops

Dietary Supplement: BioAmicus Complete

Placebo

PLACEBO COMPARATOR

Sunflower oil

Dietary Supplement: Placebo

Interventions

BioAmicus Complete DIETARY_SUPPLEMENT

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

Bioamicus Complete

Placebo DIETARY_SUPPLEMENT

Sunflower oil

Placebo

Eligibility Criteria

• Age: 1 Month - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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).

Sponsors & Collaborators

• NovoNatum Ltd: lead

Study Sites (1)

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

Saint Petersburg, 198207, Russia

RECRUITING

MeSH Terms

Conditions

Constipation; Diarrhea, Infantile; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Oleg Tyrsin

CONTACT

+7 985 784 3151; vb@novonatum.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: March 2, 2026
• Study Start: March 16, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 30, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

RU (1)