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The effect of probiotic in infantile colic

The effect of probiotics on crying time and frequency in infants with colic compared to placebo, a clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20131217015835N8
Enrollment
76
Registered
2020-08-06
Start date
2015-01-26
Completion date
Unknown
Last updated
2020-08-17

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 Drop from Zist Takhmir Company containing a total of three beneficial bacterial strains L reuteri, L Rhamnosus, and bifidobacterium infantis and also conta

Sponsors

Zanjan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Months

Inclusion criteria

Inclusion criteria: Age less than three months or 13 weeks upon admission The gestational age of more than 36 weeks The birth weight greater than 2500 grams Appropriate weighing more than 100 grams per week

Exclusion criteria

Exclusion criteria: Admission to hospital for any reason Parents uncooperation

Design outcomes

Primary

MeasureTime frame
The duration of the cry of the infant colic. Timepoint: Third week. Method of measurement: Hours a day.;Duration of sleep in 24 hours. Timepoint: In the first, second, third, and fourth weeks of the onset of treatment. Method of measurement: Hours a day.;Crying frequency in a day. Timepoint: In the first, second, third, and fourth weeks of the onset of treatment. Method of measurement: Times in day.

Secondary

MeasureTime frame
Frequency of defecation. Timepoint: In the first, second, third and fourth weeks of the onset of treatment. Method of measurement: Times a day.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParisa Khoshnevisasl

Zanjan University of Medical Sciences

khoshnevis@zums.ac.ir+98 24 3347 2737

Outcome results

None listed

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