"Comparison of the effectiveness of Simethicone with probiotics in the treatment of infantile Colic

Comparison of the effectiveness of Simethicone with probiotics in the treatment of colic in infants aged 2 weeks to 6 months: A randomized double blinded clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20151020024625N26

Enrollment

Registered

2026-05-01

Start date

2026-05-10

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infantile colic. Colic (bilious) (infantile) (intestinal) (recurrent) (spasmodic)

Interventions

Intervention 1: Intervention group: Probiotic group, they will receive 5 drops daily (equivalent to 10^8 CFU) of the L. reuteri DSM 17938 strain for 28 days. Intervention 2: Simethicone group, they wi

Eligibility

Sex/Gender

All

Age

14 Days to 4 Months

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of Infantile Colic Term delivery

Exclusion criteria

Exclusion criteria: Acute or chronic gastrointestinal disease Presence of active infection Known metabolic, neurological, or cardiovascular diseases

Design outcomes

Primary

Measure	Time frame
Decreasing in the frequency and duration of crying (reduction in crying time to less than 3 hours per day after one week of treatment). Timepoint: 7, 14, 21 and 28 days after initiating of treatment. Method of measurement: Based on Wessel's Rule of Threes for diagnosing of infantile colic.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehri Ayati

Semnan University of Medical Sciences

dr.m.ayati61@gmail.com+98 23 3346 0055

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026