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Tests treatment safety and results for Infantile Colic
Official title Study to Evaluate the Efficacy of a Probiotic in Infantile Colic Symptoms Relief
ClinicalTrials.gov ID: NCT05432479
What this study is testing
- What it's testing
- This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 12
You may be able to join if
- Gestational age of minimum 37 weeks.
- Birthweight of minimum 2500 g (5.5 lb.).
- Age of greater than 3 weeks and less than 12 weeks at enrolment.
- Confirmed Infantile colic defined as: parental report of crying and/or fussing ≥3 hours/day for ≥3 days/week, confirmed prior to enrolment with an...
- Participant Informed Consent form signed by parent or legal guardian.
You likely can't join if
- Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial.
- Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics).
- Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).
- Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract.
- Failure to thrive.
- Known lactose or gluten intolerance.
See the full eligibility criteria
- Gestational age of minimum 37 weeks.
- Birthweight of minimum 2500 g (5.5 lb.).
- Age of greater than 3 weeks and less than 12 weeks at enrolment.
- Confirmed Infantile colic defined as: parental report of crying and/or fussing ≥3 hours/day for ≥3 days/week, confirmed prior to enrolment with an infant behaviour diary recording \>3 hours of crying in a 24-hour period...
- Participant Informed Consent form signed by parent or legal guardian.
- Infant is considered healthy following physical exam.
- Parents/Caregivers are willing to comply with the trial procedures, and the mother of the infant can attend all three trial visits
- Use of antibiotics by the infant within 2-weeks prior to the screening visit or during the run-in period of the trial.
- Use of probiotic supplements from child's birth to enrolment (this includes infant formulas containing probiotics).
- Need for hospitalization (defined as readmission to a hospital ward after initial discharge following delivery).
- Congenital disorders that, in the opinion of the investigator, would impact the gastrointestinal tract.
- Failure to thrive.
- Known lactose or gluten intolerance.
- Known allergy to cow's milk proteins, fish, or any of the substances of the trial product or placebo.
- Known other causes for abdominal pain (e.g., pyloric stenosis).
- Participation in any other treatment clinical study.
- Immuno-compromised participant or participant with other severe chronic disorder.
- Use of probiotic supplements by breastfeeding mother from child's birth to enrolment.
- Use of antibiotics by breastfeeding mother within 2-weeks prior to the screening visit or during the run-in period of the trial.
- Any Participant/Parent/Caregiver who is an employee of the investigational site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Pune, Maharashtra, India
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 3 weeks to 12 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Pune, Maharashtra, India. 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.