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Evaluation of the effect of Lactobacillus reuteri probiotic in functional constipation

Evaluation of the effectiveness of Lactobacillus reuteri probiotic versus placebo in the treatment of functional constipation in children 3 to 18 years old

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20150706023084N13
Enrollment
160
Registered
2021-12-29
Start date
2022-01-21
Completion date
Unknown
Last updated
2022-01-11

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

Conditions

functional constipation in children. Constipation

Interventions

Intervention 1: Intervention group: includes 80 patients who are diagnosed with functional constipation by a pediatric gastroenterologist for 28 days of probiotic Lactobacillus reuteri produced by Far

Sponsors

Faradaro Fanavar Mehr Company
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Shiehmorteza

Islamic Azad University

shiehmorteza@iaups.ac.ir+98 21 2264 0056

Outcome results

None listed

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