The comparison of the efficacy of two different synbiotics in the treatment of infantile functional constipatio
- Conditions
- Infantie functional constipation.Other diseases of intestinesk59.0
- Registration Number
- IRCT20160827029535N7
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
Must include 1 month of at least 2 of the following in infants up to 4 years of age:1.Two or fewer defecations per week 2.History of excessive stool retention 3. History of painful or hard bowel movements 4. History of large-diameter stools 5. Presence of a large fecal mass in the rectum
GI Obstraction or previous GI surgery ; Recieving opiates, muscle relaxants and sedatives ; Mechanical ventilation; Underlying diseases, Central and Pripheral nervous system diseases ; Irritable bowel syndrome ;Endocrine Diseases( Hypothyroidism) ; anorectal abnormalities; recieving probiotics products since one week before intervention
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate of clinical manifestations of infantile constipation to each synbiotic in each group. Timepoint: One week and one month after beginning of intervention. Method of measurement: Questionnaire according to the new Rome IV criteria.
- Secondary Outcome Measures
Name Time Method Complications of each drug ( diarrhea, vomiting and skin rush) during intervention. Timepoint: One week and one month after intervention. Method of measurement: Questionnaire according to the occurance of diarrhea, vomiting and skin rush.