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New treatment option for Infantile Colic
Official title BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months
ClinicalTrials.gov ID: NCT07148583
What this study is testing
- What it's testing
- Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome. This study evaluates whether the multistrain probiotic BioAmicus Complete can improve caregiver-reported gastrointestinal symptoms in infants 0-24 months and is safe for use in this population.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 24
You may be able to join if
- Age 0-24 months at enrollment.
- Infant has clinician-assessed functional gastrointestinal symptoms (e.g., colic/irritability, regurgitation, constipation, loose stools), judged...
- Parent or legal guardian provides written informed consent and agrees to comply with study procedures (questionnaires/diaries and sample collection...
- Caregivers agree to avoid other probiotic products during the study period, except as directed by the study team.
You likely can't join if
- Major congenital gastrointestinal anomalies or known chronic gastrointestinal diseases requiring ongoing prescription therapy (e.g., Hirschsprung...
- 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.
- Recent use of systemic antibiotics within 14 days prior to baseline, or use of probiotic supplements within 14 days prior to baseline (per protocol).
- Participation in another treatment clinical trial within 30 days prior to enrollment or during the study.
See the full eligibility criteria
- 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.
- 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.
- Recent use of systemic antibiotics within 14 days prior to baseline, or use of probiotic supplements within 14 days prior to baseline (per protocol).
- Participation in another treatment clinical trial within 30 days prior to enrollment or during the study.
- Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or confound outcome assessments.
The study team makes the final eligibility decision.
Where it's taking place
- Haiphong, Hai Phong, Vietnam
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, 0 days to 24 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Haiphong, Hai Phong, Vietnam. 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.