Menu
Recruiting NCT07444008

Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete

No phase Interventional Infantile Colics Constipation Infantile Diarrhea Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BioAmicus Complete, Placebo.
Who it may be relevant to
Registry conditions: Infantile Colics, Constipation, Infantile Diarrhea, Atopic Dermatitis. Basic parameters: 1 months — 5 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Dietary supplement BioAmicus Complete
    BioAmicus Complete (oral drops; a mixture of 10 strains of lacto- and bifidobacteria)
  • Dietary supplement Placebo
    Sunflower oil

Primary outcome measures

  • Constipation or diarrhea [Time frame: 28 days]
  • Frequency and duration of colic [Time frame: 28 days]
  • Gastroesophageal reflux [Time frame: 28 days]
Secondary outcome measures (2)
  • Cutaneous manifestations of food allergy. [Time frame: 28 days]
  • Weight increase [Time frame: 28 days]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Russia · 1 center
  • St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 43" — Saint Petersburg

Identifiers

NCT: NCT07444008 · BioAmicus-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗