BridgeMD
New treatment option for Infantile Colics
Official title Randomized, Blinded, Placebo-Controlled Evaluation of BioAmicus Complete
ClinicalTrials.gov ID: NCT07444008
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 5
You may be able to join 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...
- 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.
You likely can't join 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).
See the full eligibility 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.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Saint Petersburg, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 5 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Saint Petersburg, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.