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

NCT06458881 | Completed

• 1 other identifier: 196/2023
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The primary endpoint was the infant crying duration at 28 days.

  reatment success was defined as at least 50% reduction in crying time from baseline to day 28 postintervention.

Interventions

Mixture of Simethicone and Tyndallized Bacillus Coagulans COMBINATION_PRODUCT

. 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.

Eligibility Criteria

• Age: 1 Month - 12 Months
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Sample size determination was guided by the primary objective of the study and was based on the approach described in Sung et al. (12), using data subsequently published in Sung et al. (13). Specifically, we considered as a comparison base, and as a proxy for a physiological reduction in crying, the success rate (defined as a reduction in crying time by at least 50%) in the placebo group, which Sung et al. (13) reported to be 39%. In comparison, the success rate observed in subjects treated with probiotics was 66%. Therefore, a sample size of 37 subjects was found sufficient to achieve 90% power to detect a success rate of 0.66 (assuming under the null hypothesis a proportion of 0.39), using a two-sided exact test with a 5% significance level. Considering a dropout rate of 10%, 41 patients were enrolled.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

Marina Russo

Napoli, 80121, Italy

Location

Related Publications (1)

• Saviano M, Russo M, Buono P, La Pietra M, Sorrentino E, Chianese A, Ementato S, Illiano G, Napolitano G, Dolce P, Staiano A. Efficacy of a mixture of simethicone and tyndallized bacillus coagulans in infant colic: a pilot study on behalf of Italian Society of Pediatrics (SIP). Ital J Pediatr. 2025 Nov 12;51(1):300. doi: 10.1186/s13052-025-02140-2.

  PMID: 41225617 DERIVED

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dott. Marina Russo

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: July 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 28, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)