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EFFICACY OF A MIXTURE OF SIMETHICONE AND TYNDALLIZED BACILLUS COAGULANS IN INFANT COLIC: A PILOT STUDY

NCT06458881 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2024-06-14

No results posted yet for this study

Summary

: A pilot study was conducted on a group of 41 infants with diagnosis of Infant Colic according to Rome IV criteria. We administered to all the enrolled infants a mixture of Tyndallized bacillus coagulans and Simethicone for 28 days. The primary outcome was the mean infant crying duration at 28th day. The secondary outcome was the improvement in the quality of sleep and infants' and parents' quality of life

Conditions

  • Infant Colic

Interventions

COMBINATION_PRODUCT

Mixture of Simethicone and Tyndallized Bacillus Coagulans

. Enrolled infants were treated for 28 days with a mixture of Tyndallized B. Coagulans and Simethicone: 20 drops, four times a day. At enrolment, clinical and dietary history, obstetrical data and anthropometry were recorded. The subjects were classified as having IC based on their parents' responses to the validated questionnaires regarding IC according to Rome IV criteria.

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Eligibility

Min Age
1 Month
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-02-01
Completion
2024-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06458881 on ClinicalTrials.gov