Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Gluten Free Diet Plus Standard Medical Therapy for 8 weeks: Participants will receive an individualized Gluten Free Diet with counselling by a registered dietitian for eight weeks in ad
Sponsors
Dayanand Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Age 18 to 65 years Patients diagnosed with functional dyspepsia as per Rome IV criteria Normal esophagogastroduodenoscopy (EGD) mucosal findings Duodenal biopsy showing eosinophil count greater than 13 eosinophils per high power field
Exclusion criteria
Exclusion criteria: Patients with organic cause of dyspepsia (Peptic Ulcer Disease (PUD), gastric carcinoma, pancreatico-biliary disease, inflammatory bowel disease, celiac disease, etc.) Patients with advanced comorbidities (uncontrolled diabetes, hypertension or thyroid disorder, chronic liver disease, advanced cardio-pulmonary, CKD, or advanced psychiatric illness) Patients with any eosinophilic condition of any other area of GIT Patients having parasitic infections (diagnosed with stool routine examination) or peripheral eosinophilia on CBC testing Patients with any abdominal surgery within past 6 months Patients on drugs known to cause eosinophilia like anti-epileptics (carbamazepine, phenytoin, lamotrigine, etc.), fluoxetine, captopril and antibiotics (ampicillin, isoniazid, rifampin, linezolid, trimethoprim-sulfamethoxazole, vancomycin, etc.) Patients on drugs known to cause duodenal inflammation such as NSAIDs, aspirin, clopidogrel, olmesartan, etc. Patient tested positive for H. pylori by RUT Pregnant and lactating females Patients not willing to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean duodenal eosinophil count per high power field from baselineTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of symptom responders at Week 4. Proportion of symptom responders at Week 8. Change in individual dyspepsia symptom scores measured using the Short Form Nepean Dyspepsia Index symptom domain from baseline to Week 4. Change in individual dyspepsia symptom scores measured using the Short Form Nepean Dyspepsia Index symptom domain from baseline to Week 8. Change in Health Related Quality of Life measured using the Short Form Nepean Dyspepsia Life Quality Index from baseline to Week 8. Change in anxiety scores measured using the Generalized Anxiety Disorder 7 questionnaire from baseline to Week 8. Change in depression scores measured using the Patient Health Questionnaire 9 from baseline to Week 8. Adherence to assigned intervention assessed by food diaries, weekly telephone follow up and pill counts. Incidence of adverse events during the study period. Incidence of serious adverse events during the study period.Timepoint: 8 week study period | — |
Countries
India
Contacts
Public ContactDr Omesh Goyal
Dayanand Medical College and Hospital
Outcome results
None listed