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The efficacy and safety of probiotics in treating children with chronic abdominal pain

Efficacy and Safety of Polystrain Probiotics for Chronic Abdominal Pain in children aged 7-14 years: A Prospective, Open-labelled, Randomised, Parallel Study - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066510
Enrollment
132
Registered
2024-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: K929- Disease of digestive system, unspecified

Interventions

Intervention1: Polystrain Probiotics, BIFILAC HP: Twice a Day as an add on to Standard of care for 2 weeks Control Intervention1: Standard of care: For 2 weeks

Sponsors

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Chronic Abdominal Pain diagnosed according to ROME 4 Criteria. Legally Authorized Representative/Participants willing to give assent/consent for the study.

Exclusion criteria

Exclusion criteria: Organic pain warning signs (includes age under 5, right upper and right lower abdominal pain, failure to thrive). Having organic disease (urinary tract infection, celiac disease, parasites, etc.) and other chronic diseases. Patient on Antibiotics, Prokinetics. Acute Infection. Undergone abdominal surgery within 1 month.

Design outcomes

Primary

MeasureTime frame
1. Changes in pain in study population ï?? Severity/Intensity ï?? Frequency ï?? Duration 2. Change in Quality of Life (QoL) in study populationTimepoint: 2nd week and 4th week

Secondary

MeasureTime frame
1. Number of patients requiring escape treatment 2. Adherence to treatmentTimepoint: 2nd week

Countries

India

Contacts

Public ContactDr Sapna Vashisth

Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak

sapnavashisth.4@gmail.com9817376219

Outcome results

None listed

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