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Investigation of the effects of Probiotics on Infantile Colic

Investigation of probiotic efficacy compared with placebo in decreasing the crying time in infants involved with infantile colic

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201205209808N1
Enrollment
60
Registered
2013-04-20
Start date
2010-01-03
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

Iinfantiel Colics. Other and unspecified abdominal painAbdominal tenderness NOS

Interventions

Intervention 1: In the probiotic group : administration of the probiotic mixture named “protexin” orally in amount of one sachet per day for 30 days. Intervention 2: In the placebo group : administra
Treatment - Drugs
In the probiotic group : administration of the probiotic mixture named “protexin” orally in amount of one sachet per day for 30 days
In the placebo group : administration of the placebo orally in amount of one sachet per day for 30 days

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: Infant ; birth weight between 2 and 4 Kg ; breast mother feeding ; no drug consumption ; diagnosis of the infantile colic (keep crying for 3 hours or more per day and 3 days or more per week) Exclusion Criteria: Infants with age less than 15 or more than 120 days ; birth weight less than 2 or more than 4 Kg ; formula consumption ; antibiotic consumption ; finding another cause for the infant crying

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Duration and frequency of crying. Timepoint: 7 and 30 days after intervention. Method of measurement: duration of crying is measured in minute, based on questionnaires.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Zeinab Noorbakhsh

Mashhad University of Medical Science

Noorbakhsh1362@gmail.com+98 51 1843 2115

Outcome results

None listed

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