Evaluation of the effectiveness of Reuteflor in the treatment of functional constipation in children aged 2 -15 years

Phase 3

Recruiting

• Conditions: constipation.; Constipation, unspecified; K59.00

• Registration Number: IRCT20090124001580N7
• Lead Sponsor: Oroumia University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Two or fewer defecations per week
History of excessive stool retention
History of painful or hard defecation
History of large-diameter stools
Presence of a large fecal mass in the rectum
At least 1 episode/wk of encopresis after the acquisition of toileting skills
History of large-diameter stools that may obstruct the toilet
Age between 2 and 15 years
Abdominal pain during defecation

Exclusion Criteria

Receipt of laxatives in the previous 4 weeks
Mental retardation
Presence of organic etiology for constipation (hypothyroidism, cystic fibrosis, Hirschsprung disease)
History of intestinal surgery
Unwillingness to participate in the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of pain. Timepoint: Two, four, eight weeks after initiation of the study. Method of measurement: Completion of the checklist.;Painful or hard defecation. Timepoint: Two, four, eight weeks after initiation of the study. Method of measurement: Completion of the checklist.;Stool consistency. Timepoint: Two, four, eight weeks after initiation of the study. Method of measurement: Completion of the checklist.;Encopresis. Timepoint: Two, four, eight weeks after initiation of the study. Method of measurement: Completion of the checklist.;Large-diameter defecation. Timepoint: Two, four, eight weeks after initiation of the study. Method of measurement: Completion of the checklist.;Abdominal pain during defecation. Timepoint: Two, four, eight weeks after initiation of the study. Method of measurement: Completion of the checklist.