non-ulcer dyspepsia. Functional dyspepsia
Conditions
Interventions
Intervention 1: Control group: The control group will continue their regular weight-maintenance diet without any restrictions on FODMAP intake for 12 weeks. Clinical symptoms and quality of life will
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age over 18 years Diagnosis of functional dyspepsia based on Rome IV criteria History of dyspeptic symptoms for at least 6 months Willingness and ability to adhere to the Low FODMAP Diet (LFD) No other gastrointestinal diseases, such as Crohn’s disease, ulcerative colitis, or celiac disease No regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) Not pregnant or breastfeeding
Exclusion criteria
Exclusion criteria: Unwillingness to continue the study Non-adherence to the intervention The occurrence of any serious adverse effects Becoming pregnant Development of any new gastrointestinal disease Regular use of NSAIDs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical symptoms. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia.;Quality of life. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI). | — |
Secondary
| Measure | Time frame |
|---|---|
| Upper Abdominal Pain. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia.;Bloating. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia.;Early Satiety. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia.;Nausea. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia.;Belching. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: GSRS Scale for Functional Dyspepsia.;Has your general emotional well-being been disturbedby your stomach problems in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI).;Have you been irritable, tense or frustrated in thelast 2 weeks because of your stomach problems?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI).;Has your ability to engage in things you usually do for fun (recreations, going out, hobbies, sports, etc.) been disturbed by your stomach problems in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI).;Has your enjoyment of things you usually do for fun (recreations, going out, hobbies, sports, etc.) been disturbed by your stomach problems in the last 2 weeks?. Timepoint: At the beginning of the study, the first month, and the third month. Method of measurement: Short-Form Nepean Dyspepsia Index (SF-NDI).;Has your ability to eat or drink (including when, what, and how much) been disturbed by your stomach problems in the | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzita Hekmatdoost
Shahid Beheshti University of Medical Sciences
Outcome results
None listed