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Efficacy of probiotic use in pediatric functional constipation

A comparison of Lactobacillus sporogenes with polyethylene glycol vs polyethylene glycol alone in the treatment of functional constipation in children: a non- inferiority trial - na

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083343
Enrollment
50
Registered
2025-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: K590- Constipation

Interventions

Intervention1: Probiotic Lactobacillus sporogenes along with standard therapy of PEG: Children in the intervention arm will be given standard therapy of Polyethylene glycol at the dose of 1-1.75 gm/kg

Sponsors

Dr Samarendra Mahapatra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged 5-14 years with functional constipation defined according to Rome IV criteria Symptomatic for more than 4 weeks

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Frequency of bowel movements per week at the 4th week of treatment in intervention and control armsTimepoint: Baseline, 4th week

Secondary

MeasureTime frame
Comparison of Stool microbiome analysis pre- treatment and at the 4th week of treatment in both the arms Timepoint: At beginning and at 4th week;Comparison of Stool consistency pre- treatment and at the 4th week of treatment in both the arms according to the Bristol Stoo Form ScaleTimepoint: At beginning and at 4th week;Comparison of adverse event between two groupsTimepoint: At 4th week

Countries

India

Contacts

Public ContactDr Samarendra Mahapatra

AIIMS Bhubaneswar

ped_samarendra@aiimsbhubaneswar.edu.in9438884180

Outcome results

None listed

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