Preventive effect of synbiotic supplement on infant colic
Phase 3
Recruiting
- Conditions
- Infant Colic.Other and unspecified abdominal painR10.4
- Registration Number
- IRCT20230123057193N2
- Lead Sponsor
- Research assistant of Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
Having a birth age of 37 to 42 weeks
Birth weight above 2000 grams
Refer to the clinic under 10 days old
The health of the baby in terms of physical examinations
Exclusion Criteria
Taking antibiotics and probiotics before starting the study
Any need for initial hospitalization or readmission
Congenital defects, immunity, metabolic and growth and development
Allergy to gluten, cow's milk protein or any substance in placebo or synbiotic syrup and lactose intolerance
Any known abdominal pain
Participation in any other intervention
Probiotic consumption by mothers
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Colic disease Incidence. Timepoint: The beginning of the intervention (before the start of the intervention), 4 weeks after the intervention and 8 weeks after the intervention. Method of measurement: Based on Rome 4 (ROM IV) criteria and doctor's diagnosis.
- Secondary Outcome Measures
Name Time Method Calprotectin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Fecal quantities using a special kit.;Mother's quality of life. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ???????? SF36.