The effect of probiotic in treatment of infantile colic

The effect of probiotic compared with placebo in decreasing the duration of crying in infants with colic

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015031611145N16

Enrollment

100

Registered

2015-12-05

Start date

2015-12-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Infantile colic. Other and unspecified abdominal pain

Interventions

Intervention 1: Intervention group: Pedilact 5 drops daily for 21 days. Intervention 2: Control group: Placebo 5 drops daily for 21 days.

Treatment - Drugs

Intervention group: Pedilact 5 drops daily for 21 days

Control group: Placebo 5 drops daily for 21 days

Eligibility

Sex/Gender

All

Age

1 Months to 3 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: Well babies aged 1-3 months; Having Wessel criteria; Birth weight more than 2500 grams; Gestational age of 37-42 weeks; 5-minute Apgar score more than 7; Parental consent Exclusion criteria: Chronic gastrointestinal diseases; Immune deficiency; A history of antibiotic or probiotics therapy; Acute disease; Allergies to materials used in the study; Lack of parental involvement

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Duration of infantile crying in 24 hours. Timepoint: Before the intervention and 7th, 14th and 21th days after intervention. Method of measurement: Recording of crying time by mother.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammad Reza Sharif

Kashan University of Medical Sciences

mrsharifmd@yahoo.com+98 31 5554 0026

Outcome results

None listed

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