Determining and Comparing The Effects of Simethicone and Gripe mixture with Probiotics on the Severity of Colic Symptoms in Infants Younger than 5 Months.

Comparison of the Effectiveness of Simethicone and Gripe mixture with Probiotics on the Severity of Colic Symptoms in Infants Younger than 5 Months.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250626066262N1

Enrollment

120

Registered

2025-08-08

Start date

2025-08-06

Completion date

Unknown

Last updated

2025-08-19

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

Conditions

Infantile Colic. Infantile colic

Interventions

Intervention 1: First Intervention group: The First Intervention Group is Given Two Bottles, one containing activated dimethicone syrup (40 mg per ml) at a dose of 20 mg 4 Times a Day for 20 Days, and

Eligibility

Sex/Gender

All

Age

21 Days to 5 Months

Inclusion criteria

Inclusion criteria: Age between 1 month old to 5 months old Diagnosis of Infantile Colic Based on the Rome IV Criteria Mother being alive

Exclusion criteria

Exclusion criteria: Premature Infants,Infants with chronic disease or Fever, Infants with congenital Anomalies Babies born to mothers with chronic disease or who are drug addicts, smokers or Suffer from Depression

Design outcomes

Primary

Measure	Time frame
Number of Hours of Crying per Day. Timepoint: At the Beginning of The Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Checklist.;Weight. Timepoint: At the Beginning of The Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Digital Scale.;Number of Feedings per Day. Timepoint: At the Beginning of The Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Checkist.;Sleeping hours per Day. Timepoint: At the Beginning of The Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Checklist.;Frequency of vomiting and diarrhea. Timepoint: At the Beginning of The Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Checklist.	—

Measure

Time frame

Number of Hours of Crying per Day. Timepoint: At the Beginning of The Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Checklist.;Weight. Timepoint: At the Beginning of The Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Digital Scale.;Number of Feedings per Day. Timepoint: At the Beginning of The Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Checkist.;Sleeping hours per Day. Timepoint: At the Beginning of The Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Checklist.;Frequency of vomiting and diarrhea. Timepoint: At the Beginning of The Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Checklist.

—

Secondary

Measure	Time frame
Number of medical consultations. Timepoint: At the Beginning of the Study (Before the Intervention) and 14 and 20 Days After Starting the Drug. Method of measurement: Checklist.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Morteza Rasti Sani

Sabzevar University of Medical Sciences

rastisanimorteza@gmail.com+98 915 518 5019

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026