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Effect of probiotic in infantile colic

Comparison the effectiveness of probiotic Lactobacillus reuteri and Placebo in reducing the time of restlessness in infants with infantile colic

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014012713489N2
Enrollment
30
Registered
2014-07-04
Start date
2013-08-23
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: Probiotic Lactobacillus reuteri (American Type culture collection Strain 55730) produced by BioGaia company 5 drops orally,every days. until the day 14 of treatment. Intervention 2: Pl
Treatment - Drugs
Placebo
Probiotic Lactobacillus reuteri (American Type culture collection Strain 55730) produced by BioGaia company 5 drops orally,every days. until the day 14 of treatment.
Placebo,(distilled water) 5 drops orally every day for 5-7 days.

Sponsors

Vice chancellor for research,Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Days to 2 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: Restless infants 15 to 60 days of age;With birth weight greater than 2500 g; Breast feeding; No signs or symptoms of chronic disease in history and initial examination; Normal urine analysis; Based on the criteria crying and agitation vessels at least 3 hours a day and more than 3 days a week Exclusion criteria: Use dry milk; use of antibiotics; Taking painkillers or carminative; chronic illnesses in infants

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Restlessness Times. Timepoint: Intervention every day starting two weeks after the intervention. Method of measurement: clinical.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Akbarian Rad

Babol University of Medical Sciences

zhr_akbarian@yahoo.com+98 11 1223 8284

Outcome results

None listed

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