Phase 2 Completed N=87 Randomized Treatment

Effects of Vivatlac Baby on Crying Behavior of Colicky Babies

Source: ClinicalTrials.gov NCT04487834 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2023

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

Summary

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

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

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. Informational only — not medical advice.