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Probiotics in the Management of Functional Constipation in Children

Evaluating the Therapeutic Effectiveness of Probiotics on Pediatric Functional Constipation in a Cohort Aged 2 to 12 Years

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231004059611N1
Enrollment
170
Registered
2024-01-08
Start date
2024-01-20
Completion date
Unknown
Last updated
2024-01-22

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

Conditions

Functional Constipation. Constipation

Interventions

Intervention 1: Intervention group: Reuteflor oral sachet, each Reuteflor sachet contains 800 million active lyophilized cells of Lactobacillus roteri (equivalent to 8*10^8 CFU), 1 to 2 sachets per da

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 2 to 12 years Having functional constipation based on Rome criteria 4 Not using probiotics, prebiotics or antibiotics 4 weeks before the start of the research No history of gastrointestinal surgery Lack of sensitivity or tolerance to Lactobacillus roteri (Reuteflor) Interest in participating in the study and consent of family/guardian

Exclusion criteria

Exclusion criteria: Children with organic digestive disorders or any other underlying disease that can affect bowel function. Children with mental disability Current use of medications that affect bowel function such as laxatives or antidiarrheals History of using probiotics, prebiotics or antibiotics 4 weeks before the start of the research Inability or unwillingness to comply with the study protocol or follow-up History of participating in a different clinical trial in the last 3 months

Design outcomes

Primary

MeasureTime frame
Functional Constipation based on ROME IV Criteria. Timepoint: Initial Presentation and Subsequent Observations on Days 7, 14, 21, and 28, as well as Two Months Post-Administration of Probiotics. Method of measurement: ROME IV Criteria.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamira Zakeri Shahvari

Bandare-abbas University of Medical Sciences

samirashahvari@gmail.com+98 76 3366 7200

Outcome results

None listed

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