Functional Gastrointestinal Disorders
Conditions
Brief summary
The goal of this interventional study is the evaluation of a diet low in fodmaps on gastric emptying in celiac patients with functional disorders.
Detailed description
The goal of this interventional study is the evaluation of a diet low in fodmaps on gastric emptying in celiac patients with functional disorders. The aims of the study are: * Evaluation of gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet (T1 and T2) in celiac patients with functional dyspepsia and non-celiac patients with functional dyspepsia. * Evaluation of gastrointestinal symptoms, quality of life, and mental health in patients with non-celiac and celiac functional disorders pre- and post-diet (T1 and T2). Participants: * Will run the 13C-octanoic acid breath test pre- and post-diet * Will complete the VAS, SF-36, and SCL-90 questionnaires pre- and post-diet * Will follow a low fodmap gluten free diet or a regular gluten-free diet for six weeks Researchers will compare celiac and non-celiac patients.
Interventions
OTHERDietary Intervention (Low Fodmap Gluten Free Diet)
The intervention provides the administration of a Low Fodmap Diet to celiac or non celiac patients with functional gastrointestinal disorders
Sponsors
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age: ≥ 18 years old * gender: male or female * patients who have signed informed consent * patients diagnosed with a functional gastrointestinal disorder who meet Rome IV criteria (according to Rome Foundation's latest revision of 2016)
Exclusion criteria
* patients who have not given informed consent * patients without a diagnosis of a functional gastrointestinal disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet (T1 and T2) in celiac patients with functional dyspepsia and non-celiac patients with functional dyspepsia | Six weeks | Evaluating gastric emptying time by a 13C-Octanoic Acid Breath Test, pre and post-diet |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the effects of dietary recommendation for a diet low in Oligo-, Di- and Monosaccharides and Polyols (FODMAPs) or a balanced diet in celiac and non-celiac dyspeptic patients on gastric emptying time | Six weeks | Comparison of the effects of dietary recommendation for a diet low in Oligo-, Di- and Monosaccharides and Polyols (FODMAPs) or a balanced diet in celiac and non-celiac dyspeptic patients on gastric emptying time |
| Evaluation of gastrointestinal symptoms (VAS) | Six weeks | Evaluation of gastrointestinal symptoms through Visual Analogue Scale (VAS) in celiac and non-celiac dyspeptic patients pre- and post-nutritional intervention (t1 and t2) |
| Evaluation of quality of life (SF-36) | Six weeks | Evaluation of quality of life through a questionnaire on the health state (Short Form Health Survey, SF-36) in celiac and non-celiac dyspeptic patients pre- and post-nutritional intervention (t1 and t2) |
| Evaluation of mental health (SCL-90) | Six weeks | Evaluation of mental health through a questionnaire on the health state (Symptom Check List, SCL-90) in celiac and non-celiac dyspeptic patients pre- and post-nutritional intervention (t1 and t2) |
Countries
Italy
Outcome results
None listed