Effect of dietary modification in patients with functional dyspepsia
- Conditions
- Health Condition 1: K30- Functional dyspepsia
- Registration Number
- CTRI/2019/06/019852
- Lead Sponsor
- Dept of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 105
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Proportion of responders (symptom relief) <br/ ><br>Timepoint: 4 weeks
- Secondary Outcome Measures
Name Time Method Improvement in quality of life <br/ ><br>Timepoint: four weeks