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

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.

Study Overview

• Status: Recruiting
• Conditions: Constipation; Atopic Dermatitis; Infantile Diarrhea; Infantile Colics
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: BioAmicus Complete

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oleg Tyrsin; Phone Number: +7 985 784 3151; Email: vb@novonatum.com

Study Locations

• Russia
  • Saint Petersburg, Russia, 198207
    • Recruiting
    • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43"
    • Contact: Sergey Rodygin; Phone Number: +7 (812) 403-03-34; Email: gp43@mail.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Sunflower oil	Dietary supplement: Placebo; Sunflower oil
Experimental: Bioamicus Complete; BioAmicus Complete drops	Dietary supplement: BioAmicus Complete; BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cutaneous manifestations of food allergy.	Number of patientswithhe presence or absence of clinical manifestations of skin symptoms of food allergy (atopic dermatitis/eczema)	28 days
Weight increase	Change in body weight relative to the baseline	28 days

Collaborators and Investigators

• Sponsor: NovoNatum Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Signs and Symptoms, Digestive; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Diarrhea; Dermatitis, Atopic; Constipation; Diarrhea, Infantile
• Other Study ID Numbers: BioAmicus-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No