Evaluation of the effect of Lactobacillus reuteri probiotic in functional constipatio

Phase 3

• Conditions: functional constipation in children.; Constipation; K59.0

• Registration Number: IRCT20150706023084N13
• Lead Sponsor: Faradaro Fanavar Mehr Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 January 2022

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

People with functional constipation according to ROME IV criteria
Diagnosis of functional constipation should be based on a pediatric gastroenterologist
Age range 3 to 18 years

Exclusion Criteria

Having other underlying diseases
History of allergies to the studied drugs and their accessories
Use of any probiotics and prebiotics and laxatives other than study drugs and outside the study conditions

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stool stiffness. Timepoint: Stool stiffness is recorded daily in the questionnaire by individuals for 56 days. Method of measurement: Review by Bristol form and registration by the participant in the questionnaire form.;Number of Painful stools. Timepoint: 56 days. Method of measurement: Daily record by individual.;Stool incontinence. Timepoint: 56 days. Method of measurement: Daily record by individual.;Abdominal pain. Timepoint: 56 days. Method of measurement: Daily record by individual.;Appetite. Timepoint: 56 days. Method of measurement: Daily record by individual.;Age. Timepoint: Before starting the intervention. Method of measurement: Registered by a pediatric gastroenterologist.;Sex. Timepoint: Before starting the intervention. Method of measurement: Registered by a pediatric gastroenterologist.;Duration of treatment. Timepoint: At the end of the study. Method of measurement: Registered by a pediatric gastroenterologist.