Irritable bowel syndrome Digestive System
Conditions
Interventions
Participants will be enrolled after providing written informed consent and will be randomly assigned (by computer-generated random numbers) in a 1:1 ratio to one of two treatment groups:
Group 1: Pat
Sponsors
Magna Graecia University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age = 18 years 2. Diagnosis of irritable bowel syndrome (IBS)
Exclusion criteria
Exclusion criteria: 1. Confirmed diagnosis of celiac disease or wheat allergy 2. Organic gastrointestinal disorders 3. Severe systemic conditions 4. Malnutrition 5. Psychiatric disorders 6. Adherence to specific dietary regimes 7. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal symptoms measured using the Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) at baseline and after 4 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at baseline and after 4 weeks of treatment: 1. Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) 2. Quality of life measured using the SF-36 scale (IQOLA SF-36 Italian version 1.6) | — |
Countries
Italy
Contacts
Public ContactTiziana Montalcini
Outcome results
None listed