Recruiting

CTBE2503BioAmicus Complete Probiotic for Infant Gastrointestinal Symptoms

What is being tested

BioAmicus Complete

+ Usual Care (No Probiotic)

Dietary SupplementOther

Who is being recruted

Colic+9

+ Deglutition Disorders

+ Digestive System Diseases

Until 24 Months

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional

Study Start: September 2025

See protocol details

Summary

Principal SponsorHaiphong University of Medicine and Pharmacy

Study ContactNguyen Thi Thu Phuong, MD, PhD

Last updated: January 30, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 5, 2025

Actual date on which the first participant was enrolled.

This study explores whether the probiotic "BioAmicus Complete" can help improve stomach and digestive issues in infants aged 0 to 24 months. Probiotics are good bacteria that can support a healthy gut, and this study focuses on how BioAmicus Complete might help with symptoms like colic, regurgitation, and irregular stooling patterns. The research is important because it might offer a new way to ease these common digestive problems in babies, potentially reducing the stress for caregivers and the need for healthcare visits. In this trial, infants will be divided into groups where some receive the BioAmicus Complete probiotic while others continue with usual care. The probiotic is given orally. Researchers will observe changes in the babies' digestive symptoms, as well as any effects on the gut microbiome—the community of bacteria in the intestines. They will also look at how these changes impact caregivers' quality of life, healthcare visits, and the infants' growth and safety. By comparing these outcomes, the study aims to see if the probiotic is effective and safe for infants dealing with digestive issues.

Official TitleEvaluation of the Efficacy and Safety of the Multistrain Probiotic "BioAmicus Complete" in Improving Gastrointestinal Symptoms in Children Aged 0-24 Months: A Randomized, Open-Label, Parallel-Group, Controlled Trial

NCT07148583

Principal SponsorHaiphong University of Medicine and Pharmacy

Study ContactNguyen Thi Thu Phuong, MD, PhD

Last updated: January 30, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

110 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 24 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ColicDeglutition DisordersDigestive System DiseasesEsophageal DiseasesGastroesophageal RefluxGastrointestinal DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDysbiosis

Criteria

4 inclusion criteria required to participate

Age 0-24 months at enrollment.

Infant has clinician-assessed functional gastrointestinal symptoms (e.g., colic/irritability, regurgitation, constipation, loose stools), judged suitable for study participation.

Parent or legal guardian provides written informed consent and agrees to comply with study procedures (questionnaires/diaries and sample collection, if applicable).

Caregivers agree to avoid other probiotic products during the study period, except as directed by the study team.

7 exclusion criteria prevent from participating

Major congenital gastrointestinal anomalies or known chronic gastrointestinal diseases requiring ongoing prescription therapy (e.g., Hirschsprung disease, inflammatory bowel disease, short-bowel syndrome).

Clinically unstable condition or severe/critical illness that could interfere with participation or safety in the opinion of the investigator.

Known or suspected primary or secondary immunodeficiency, or current immunosuppressive therapy.

History of severe allergy or hypersensitivity to components of the investigational product.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants receive BioAmicus Complete (multistrain probiotic) oral drops in addition to usual care for infant functional GI symptoms. Product is administered by caregivers per protocol/label for 42 days; adherence is recorded. No other probiotic products are permitted during the study. Concomitant medications and routine management are allowed at the investigator's discretion.

Group II

Active Comparator

Participants receive standard clinical management per local practice for infant functional gastrointestinal symptoms. No probiotic supplementation is provided (participants are asked to avoid other probiotic products during the study). Concomitant medications and supportive care may be used as clinically indicated at the investigator's discretion.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Clinical Trial and Bioequivalence Center

Haiphong, VietnamOpen Clinical Trial and Bioequivalence Center in Google Maps

Recruiting

One Study Center