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Effect of Adding Probiotics to Proton Pump Inhibitors (PPIs) in the Treatment of Functional Dyspepsia in Children

Investigating the Effect of Adding Probiotics to Proton Pump Inhibitors (PPIs) in the Treatment of Functional Dyspepsia in Children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151020024625N25
Enrollment
44
Registered
2026-05-01
Start date
2026-03-21
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Functional dyspepsia. Functional dyspepsia

Interventions

Intervention 1: Intervention group: Probiotic: One sachet of Rotflor containing Lactobacillus reuteri, taken once daily dissolved in water for 4 weeks. PPI: Standard dose of pantoprazole based on the
for weight 40 kg and above: 40 mg once daily). Intervention 2: Control group: PPI: Standard dose of pantoprazole based on the child's age and weight (for weight 15 kg to less than 40 kg: 20 mg once da
for weight 40 kg and above: 40 mg once daily).

Sponsors

Semnan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 12 Years

Inclusion criteria

Inclusion criteria: Diagnosis of functional dyspepsia based on the Rome IV diagnostic criteria.

Exclusion criteria

Exclusion criteria: Organic gastrointestinal diseases Use of antibiotics or any probiotic products in the 4 weeks leading up to the start of the study

Design outcomes

Primary

MeasureTime frame
Common symptoms of dyspepsia include abdominal pain, bloating, early satiety, nausea, vomiting, and diarrhea. Timepoint: 28 days after treatment. Method of measurement: ROME IV score.

Secondary

MeasureTime frame
Quality of life. Timepoint: 28 days after treatment. Method of measurement: PedsQL™ Gastrointestinal Symptoms Module.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehri Ayati

Semnan University of Medical Sciences

dr.m.ayati61@gmail.com+98 23 3346 0055

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026