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

Evaluation of the effectiveness of Reuteflor in the treatment of functional constipation: double-blind randomized controlled clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090124001580N7

Enrollment

Registered

2022-12-28

Start date

2022-12-06

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

constipation. Constipation, unspecified

Interventions

Intervention 1: Intervention group: Children aged 2-15 years with chronic functional constipation who will orally receive polyethylene glycol 3350 syrup (Kimagaran Eam and Sanat Royan Company) in the

Eligibility

Sex/Gender

All

Age

2 Years to 15 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Leila Kheirollahi Kalvanagh

Oroumia University of Medical Sciences

alisina1386@yahoo.com+98 44 3223 7078

Outcome results

None listed

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