Phase 2 N=87 Randomized Treatment

Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

Infantile Colic

Bottom Line

View on ClinicalTrials.gov: NCT04487834 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

Primary outcome: Primary: Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline — 6; 39 Participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Simethicone Solution (Drug); Vivatlac Baby (Dietary_supplement)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With a Reduction of Days Crying Equal or More Than 50 Percent From Baseline	6; 39	<0.0001 sig
PRIMARY Number of Participants With a Reduction of Average Duration of Evening Crying Equal or More Than 50 Percent	13; 46	0.0001 sig
PRIMARY Number of Participants With a Reduction of Average Number of Crying Phases Per Day Equal or More Than 50 Percent	14; 27	0.4852

Summary

Open trial with two parallel arms, assessing the effects of Simethicone and Vivatlac Baby in babies diagnosed for infantile colic.

Eligibility Criteria

Inclusion Criteria

diagnosed for infantile colic according to Wessel's criteria

Exclusion Criteria

previous treatment with probiotic or synbiotic
previous treatment with antibiotics

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04487834). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.