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Effect of dietary modification in patients with functional dyspepsia

To study the effect of low FODMAP diet on symptoms and quality of life in patients with Functional Dyspepsia - FFD

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/06/019852
Enrollment
120
Registered
2019-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: K30- Functional dyspepsia

Interventions

Intervention1: Low FODMAP diet (fermentable oligosaccharides, monosaccharides, disaccharides and polyols): The low FODMAP diet implies a restricted intake of foods containing fermentable oligosacchari

Sponsors

Dept of Gastroenterology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age- 18-70 years 2. FD diagnosed according to ROME IV criteria. 3. Patients having inadequate relief of dyspepsia symptoms on current medications. 4. Upper GI Endoscopy negative for any organic cause for dyspepsia performed in the last 2 years. 5. H pylori infection negative by non-invasive testing or biopsy. 6. Celiac disease excluded by serology and/or biopsy

Exclusion criteria

Exclusion criteria: 1. Presence of alarm symptoms like loss of appetite, loss of weight, dysphagia, anemia, new onset dyspepsia after 50 years age, hematemesis/malena, severe pain abdomen 2. Presence of a severe cardiac, liver, neurological or psychiatric disease 3. Predominant symptoms of another GI disease (e.g. IBS, GERD, gastroparesis, inflammatory bowel disease, Functional constipation/diarrhoea) that could explain the current symptoms. 4. Patients who are already on a diet excessively restricting certain nutrients before entering the study (e.g. low in FODMAPs, gluten-free, lactose free diet). 5. Prescription of bowel preparation for investigative procedures, antibiotic therapy, prebiotics or probiotics, and change of dyspepsia medication during the previous four weeks. 6. History of surgery involving upper GI tract 7. History of lactose/fructose intolerance, unless symptoms persist on a lactose/fructose free diet 8. Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
1. Proportion of responders (symptom relief) Timepoint: 4 weeks

Secondary

MeasureTime frame
Improvement in quality of life Timepoint: four weeks

Countries

India

Contacts

Public ContactDR Omesh Goyal

Dayanand Medical College and Hospital

goyalomesh@yahoo.co.in01614688800

Outcome results

None listed

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