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The Effects of Fermentable Oligo-, Di-, Monosaccharides, and polyols (FODMAPs) Meals on gastric motor function in patients with Functional Dyspepsia: Randomized Cross over study trial

The Effects of Fermentable Oligo-, Di-, Monosaccharides, and polyols (FODMAPs) Meals on gastric motor function in patients with Functional Dyspepsia: Randomized Cross over study trial

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250916010
Enrollment
20
Registered
2025-09-16
Start date
2025-07-04
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

The present study focuses on the effect of a FODMAP-containing meal compared with a low-FODMAP meal on gastric motor function in patients with functional dyspepsia. Gastric motor function will be evaluated by measuring gastric accommodation and gastric emptying parameters after standardized test meals. The aim is to determine whether a high-FODMAP meal induces greater impairment of gastric motor function compared with a low-FODMAP meal, and whether this correlates with symptom generation in func

Interventions

1. High-FODMAP meal: Participants receive a standardized meal containing high levels of fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs). This meal is designed to evaluate the effect of
Active Comparator Other,Active Comparator Other
High FODMAP meal,Low FODMAP meal

Sponsors

King chula memorial hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 65 years 2.Diagnosis of Functional Dyspepsia according to ROME IV criteria Evaluation of postprandial fullness, early satiation, epigastric pain, or epigastric burning using an 11-point (0 to 10) numeric scale 3.Patients must rate their worst symptom intensity daily over the past 24 hours 4.Symptom considered significant if the intensity score is greater than 3 for at least three days per week after a one-week run-in period

Exclusion criteria

Exclusion criteria: 1. Having other functional gastrointestinal disorders 1) Gastroesophageal Reflux Disease 2) Irritable Bowel Syndrome 3) Functional Constipation 4) Functional Bloating 5) Functional Abdominal pain syndrome 2. Active psychiatric disease 3. Use of drugs affecting GI motility within 1 week 1) Proton pump inhibitors 2) H2 blockers 3) Potassium-competitive acid blockers 4) Prokinetics 5) Selective serotonin reuptake inhibitors 6) Antispasmodics 7) Prebiotics and probiotics 8) Antibiotics 4. Co-morbidities that can impair gastric motility include the following:

Design outcomes

Primary

MeasureTime frame
Gastric emptying time 8 hours after taking meal Lag time,Gastric accommodation 4 hours after taking meal delta change in volume as mL

Secondary

MeasureTime frame
Epigastric pain,Epigastric burn, nausea, Fullness, Bloating ,abdominal pain , diarrhea, early satiety, vomitng, diarrhea, acid regurgitation, belching within a day of testing A rating scoring system is used, where patients are asked to rate each symptom on a scale from 0 to 10 by recording form

Countries

Thailand

Contacts

Public ContactPasiri Kerdsinchai

Faculty of Medicine, Chulalongkorn University

bobowob123@gmail.com0816422823

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026