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Treatment of infantile colic with the symbiotic and comparison with Dimethicone

Evaluation and Comparison of symbiotic bifidobacterium lactis and Dimethicone on treatment of Infantile Colic; a controlled randomized trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150423021910N5
Enrollment
100
Registered
2019-01-12
Start date
2017-12-22
Completion date
Unknown
Last updated
2019-01-29

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: Every 12 hours 5 drops of BBcare formulated in Zisttakhmir Pharmacy company. Intervention 2: Control group: Dimethicone 5 drops every 8 hours formulated in Razi Pha

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
21 Days to 2 Months

Inclusion criteria

Inclusion criteria: Age between 3 weeks to 2 months Exclusive breastfeeding Gestational age between 38 to 42 weeks Existence of Wessel criteria Mother with at least diploma degree Consent of parents for participation in study

Exclusion criteria

Exclusion criteria: Lack of Intestinal or other disease Lack of congenital anomalies Lack of previous use of Prebiotics or Probiotics Lack of previous gasteroentritis Lack of previous use of Antibiotics

Design outcomes

Primary

MeasureTime frame
Duration of crying. Timepoint: Before treatment, One and Two and Three weeks after treatment. Method of measurement: Questionnaire.;Number of crying. Timepoint: Before treatment, One and Two and Three weeks after treatment. Method of measurement: Questionnaire.;Duration of sleep. Timepoint: Before treatment, One and Two and Three weeks after treatment. Method of measurement: Questionnaire.;Number of defication. Timepoint: Before treatment, One and Two and Three weeks after treatment. Method of measurement: Questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarinaz Sohrabi

Esfahan University of Medical Sciences

Frinzsohrabi@yahoo.com+98 31 3386 8247

Outcome results

None listed

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