Celiac DiseaseNCT07915063
Impact of Mediterranean Diet and Processed Food Consumption on Gastrointestinal Symptoms in Coeliac Patients on a Gluten-Free Diet
An observational study of Celiac Disease and Gluten-free Diet, run by Istituti Clinici Scientifici Maugeri SpA at 7 sites in Italy.
Trial summary
Coeliac disease is a lifelong autoimmune condition in which the immune system reacts to gluten, a protein found in wheat, barley and rye, affecting about 1% of the general population. The only currently approved treatment is a strict, lifelong gluten-free diet (GFD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease, Gluten-free Diet, Gastrointestinal Symptoms
- What is being tested?
- Mediterranean Diet Adherence Evaluation and Highly Processed Food Consumption Evaluation
- How many people
- 300 participants
- Where
- 7 sitesItaly
- Study dates
- 1 Jul 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (age > 18 years) with biopsy-confirmed coeliac disease on a strict gluten-free diet for at least 12 months and with histological evidence of mucosal recovery on follow-up duodenal biopsy, consecutively recruited during routine follow-up visits at 10 participating Italian gastroenterology outpatient clinics.
Who may be able to join
- Adult patients (age > 18 years)
- Diagnosis of coeliac disease based on positive IgA tissue transglutaminase / endomysial antibodies and villous atrophy on duodenal biopsy in accordance with major international guidelines
- Strict adherence to a gluten-free diet (GFD) for at least 12 months
- Evidence of duodenal mucosal recovery on a follow-up biopsy
- Regularly attending the participating gastroenterology outpatient clinics for follow-up
Who cannot join
- Coeliac patients with poor gluten-free diet adherence and/or evidence of persistent villous atrophy on follow-up duodenal biopsy
- Patients who follow a vegetarian/vegan diet or other restrictive diets
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Italy7 sites, 7 recruiting
- Recruiting
ASST Spedali Civili di Brescia, Gastroenterologia
Brescia, BS, 25123
Chiara Ricci, MD, chiara.ricci@unibs.it, chiara.ricci@unibs.it
- Recruiting
Università degli Studi di Ferrara
Ferrara, FE, 44121
Giacomo Caio, caigmp@unife.it, caigmp@unife.it
- Recruiting
Center for Prevention and Diagnosis of Celiac Disease - Gastroenterology and Endoscopy Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Michigan, 20122
Principal Investigator, leda.roncoroni@unimi.it, leda.roncoroni@unimi.it
- Recruiting
University of Padua, Department of Surgery, Oncology and Gastroenterology
Padua, PD, 35128
Fabiana Zingone, MD, PhD, fabiana.zingone@unipd.it, fabiana.zingone@unipd.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo, SC Medicina Generale
Pavia, PV, 27100
Principal Investigator, a.disabatino@smatteo.pv.it, a.disabatino@smatteo.pv.it
- Recruiting
ICS Maugeri SpA IRCCS, Gastroenterology Unit
Pavia, PV, 27100
Annalisa Schiepatti, MD, PhD, +39 0382592695, annalisa.schiepatti@icsmaugeri.it
- Recruiting
Gastroenterology Unit, Santa Maria delle Croci Hospital
Ravenna, RA, 48121
Alessandro Mussetto, +390382592695, alessandro.mussetto@auslromagna.it
About this study
Official title: MEDITERRANEAN DIET, HIGHLY PROCESSED FOODS AND THEIR IMPACT ON GASTROINTESTINAL SYMPTOMS, NUTRITIONAL STATUS AND QUALITY OF LIFE IN ADULT COELIAC DISEASE PATIENTS ON A GLUTEN FREE DIET: A MULTICENTRE CROSS-SECTIONAL STUDY
Coeliac disease is a lifelong autoimmune condition in which the immune system reacts to gluten, a protein found in wheat, barley and rye, affecting about 1% of the general population. The only currently approved treatment is a strict, lifelong gluten-free diet (GFD). Although strict adherence to a gluten-free diet leads to mucosal recovery in most patients, up to 20-30% of coeliac patients continue to experience persistent gastrointestinal symptoms (such as abdominal pain, bloating, diarrhoea or constipation). Furthermore, commercially prepared gluten-free products often contain higher amounts of fat, sugar and salt, and lower amounts of fibre, protein, folate and vitamins compared with gluten-containing equivalents.
Conversely, the Mediterranean diet-rich in vegetables, fruits, legumes, fish, nuts and extra-virgin olive oil-is widely recognised for its benefits on cardiovascular, metabolic and gut health, as well as quality of life, in contrast to diets rich in highly or ultra-processed foods.
This multicentre cross-sectional observational study aims to evaluate whether adult coeliac patients on a long-term strict gluten-free diet whose habitual diet more closely aligns with the Mediterranean dietary pattern are less likely to experience persistent gastrointestinal symptoms and have a better quality of life and nutritional status, and conversely whether higher consumption of highly processed foods is associated with worse symptoms, poorer quality of life and less adequate nutritional status. No dietary intervention is provided as part of the study; participants complete validated questionnaires and undergo routine anthropometric and blood assessments during a single regular outpatient follow-up visit.
Read the detailed description
This is a multicentre, observational, cross-sectional, no-profit study promoted and coordinated by ICS Maugeri SpA IRCCS di Pavia (Protocol Code: CTSPV40-24).
Objectives:
- Primary Objective: To evaluate the relationship between adherence to a Mediterranean diet and gastrointestinal symptoms, coeliac disease-related quality of life, and nutritional status in a population of adult coeliac patients on a strict gluten-free diet (GFD) regularly followed at participating gastroenterology outpatient clinics.
- Secondary Objective: To evaluate whether coeliac patients who consume higher amounts of highly processed (ultra-processed) foods have more persistent gastrointestinal symptoms, a worse quality of life, and a less adequate nutritional status.
Study Procedures and Observational Nature:
Patients attending routine gastroenterology outpatient follow-up visits will be invited to participate. All enrolled patients must have been on a strict GFD for at least 12 months with histological evidence of duodenal mucosal recovery on a follow-up biopsy. As clarified with the Ethics Committee (CET Lombardia 6), no specific Mediterranean diet is prescribed or provided within this study: all patients were instructed on how to follow a strict GFD at the time of coeliac disease diagnosis by expert physicians or dietitians as part of standard clinical practice, completely independently of this study. During a single study visit (with no scheduled study follow-up), the degree of adherence to the Mediterranean diet, consumption of highly processed foods, GFD compliance, gastrointestinal symptoms, and quality of life are assessed using standardized, validated questionnaires:
- PyrMDS: 15-item Pyramid-based Mediterranean Diet Score (score range 0-15).
- sQ-HPF: Short screening Questionnaire of Highly Processed Food consumption (score range 0-14 and % HPF).
- Biagi GFD Score: Gluten-free diet adherence score (score range 0-4).
- GSRS-CD (CeD-GSRS): Gastrointestinal Symptom Rating Scale including the 10 items on the Celiac Disease domains (7-point Likert scale per item).
- CDQ (CD-QOL): Celiac Disease-specific Quality of Life scale, Italian validated version (20 items on a 5-point Likert scale).
Nutritional status is evaluated through standard anthropometric measurements (height, weight, BMI, waist circumference) and routine clinical practice biochemical blood tests (hemoglobin, ferritin, folate, vitamin B12, vitamin D, calcium, albumin, ALT, AST, GGT, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, and fasting glucose).
Sample Size and Statistical Plan:
A minimum of 300 adult coeliac patients will be enrolled across 10 Italian centres over approximately 12-18 months (providing ~75% power to detect a small-to-medium effect size of Cohen's d = 0.3 at alpha = 0.05, and >80% power for Cohen's d = 0.5, while supporting multivariable regression models). Descriptive statistics, independent samples t-tests or Mann-Whitney U tests, Chi-square or Fisher's exact tests, Pearson's or Spearman's correlation coefficients, multiple linear regression models (for continuous outcomes), and multivariable logistic regression models (for dichotomous outcomes such as presence/absence of persistent gastrointestinal symptoms) will be used, adjusting for potential confounders including age, sex, duration of GFD, and comorbidities. Missing data on key variables will be addressed via multiple imputation with sensitivity analyses. Two-sided p-values < 0.05 will be considered statistically significant.
- Conditions
- Celiac Disease, Gluten-free Diet, Gastrointestinal Symptoms
- Being tested
- Mediterranean Diet Adherence Evaluation, Highly Processed Food Consumption Evaluation
- Keywords
- Coeliac disease, Celiac disease, Gluten-free diet, Mediterranean diet, Highly processed foods, Ultra-processed foods, Persistent gastrointestinal symptoms, Quality of life, Nutritional status
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediterranean Diet Adherence EvaluationOther
Also called 15-Items Pyramid-based Mediterranean Diet Score (PyrMDS)
Observational assessment of the degree of adherence to the Mediterranean dietary pattern within the patient's habitual gluten-free diet, measured using the validated 15-item Pyramid-based Mediterranean Diet Score (PyrMDS, continuous score 0 to 15 across 15 food groups: vegetables, legumes, fruits, nuts, cereals, dairy, fish, red meat, processed meat, white meat, eggs, potatoes, sweets, alcohol, and olive oil). No dietary intervention is administered.
Highly Processed Food Consumption EvaluationOther
Also called Short Questionnaire of Highly Processed Food consumption (sQ-HPF), Ultra-Processed Foods (UPF) intake
Observational assessment of habitual consumption of highly processed / ultra-processed foods within the patient's gluten-free diet, measured using the validated short screening Questionnaire of Highly Processed Food consumption (sQ-HPF, score range 0 to 14 and estimated % HPF). No dietary intervention is administered.
| Study group | Role | What they receive |
|---|---|---|
| Adult Coeliac Disease Patients on a Long-Term Gluten-Free Diet | Adult patients (age > 18 years) with biopsy-proven coeliac disease on a strict gluten-free diet for at least 12 months and with documented duodenal mucosal recovery on follow-up biopsy, attending routine gastroenterology outpatient follow-up visits at the participating centres. Receives: Other: Mediterranean Diet Adherence Evaluation; Other: Highly Processed Food Consumption Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Celiac Disease Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score
Severity of gastrointestinal symptoms over the past week, measured with the 10-item CeD-GSRS. Each item is rated on a 7-point Likert scale (1 = no discomfort at all; 7 = very severe discomfort). The score is the mean of the 10 items, ranging from 1 to 7, and higher scores indicate more severe symptoms. The score will be analysed in relation to Mediterranean diet adherence (PyrMDS) and highly processed food consumption (sQ-HPF), using correlation and multivariable linear regression.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Celiac Disease-Specific Quality of Life (CD-QOL) Score
Coeliac disease-specific quality of life over the past 30 days, measured with the Italian validated 20-item CD-QOL. Items are rated on a 5-point Likert scale and the total score is transformed to a 0-100 scale, where higher scores indicate better quality of life. The score will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation and multivariable linear regression.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Pyramid-based Mediterranean Diet Score (PyrMDS)
Adherence to the Mediterranean dietary pattern, measured with the 15-item PyrMDS. The score is continuous and ranges from 0 to 15, where higher scores indicate greater adherence.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Body Mass Index (BMI)
BMI is calculated from measured weight and height (kg/m²). It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation and multivariable linear regression.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Secondary outcomes (9)
Short Questionnaire of Highly Processed Food Consumption (sQ-HPF) Score
Habitual consumption of highly processed foods, measured with the sQ-HPF. The score ranges from 0 to 14, where higher scores indicate greater consumption.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Gluten-Free Diet Adherence (Biagi Score)
Adherence to the gluten-free diet, measured with the Biagi score. The score ranges from 0 to 4, where higher scores indicate stricter adherence.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Percentage of Participants with Persistent Gastrointestinal Symptoms
The proportion of participants with persistent self-reported gastrointestinal symptoms. This proportion will be analysed in relation to PyrMDS and sQ-HPF scores using multivariable logistic regression.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Waist Circumference
Waist circumference (cm), measured according to standard procedures. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Total Cholesterol
Serum total cholesterol (mg/dL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis.
Measured: Baseline (Single cross-sectional study visit, Day 1)
LDL Cholesterol
Serum LDL cholesterol (mg/dL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis.
Measured: Baseline (Single cross-sectional study visit, Day 1)
HDL Cholesterol
Serum LDL cholesterol (mg/dL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Triglycerides
Serum triglycerides (mg/dL) from routine blood tests. They will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Fasting Glucose
Fasting plasma glucose (mg/dL) from routine blood tests. It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation analysis.
Measured: Baseline (Single cross-sectional study visit, Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Istituti Clinici Scientifici Maugeri SpAThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Salerno, Salerno, Italy, Università degli Studi di Napoli Federico II, Napoli, Italy, Università degli Studi di Ferrara, Ferrara, Italy, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, ASST Spedali Civili di Brescia, Brescia, Italy, University of Padua, Italy, Santa Maria delle Croci Hospital, Ravenna, Italy, Universita degli Studi di Palermo
- Responsible party
- Sponsor
- Investigators
- Annalisa Schiepatti, MD, PhD, Principal investigator, ICS Maugeri SpA IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915063
- Sponsor's protocol ID
- CTSPV40-24
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD not shared due to privacy and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MEDITERRANEAN DIET, HIGHLY PROCESSED FOODS AND THEIR IMPACT ON GASTROINTESTINAL SYMPTOMS, NUTRITIONAL STATUS AND QUALITY OF LIFE IN ADULT COELIAC DISEASE PATIENTS ON A GLUTEN FREE DIET: A MULTICENTRE CROSS-SECTIONAL STUDY
- ClinicalTrials.gov ID
- NCT07915063
- Acronym / sponsor ID
- CTSPV40-24
- Conditions
- Celiac Disease, Gluten-free Diet, Gastrointestinal Symptoms
- Keywords
- Coeliac disease, Celiac disease, Gluten-free diet, Mediterranean diet, Highly processed foods, Ultra-processed foods, Persistent gastrointestinal symptoms, Quality of life
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Istituti Clinici Scientifici Maugeri SpAUniversity, hospital or other
- Collaborators
- Università degli Studi di Salerno, Salerno, Italy, Università degli Studi di Napoli Federico II, Napoli, Italy, Università degli Studi di Ferrara, Ferrara, Italy, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, ASST Spedali Civili di Brescia, Brescia, Italy, University of Padua, Italy, Santa Maria delle Croci Hospital, Ravenna, Italy, Universita degli Studi di Palermo
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coeliac disease is a lifelong autoimmune condition in which the immune system reacts to gluten, a protein found in wheat, barley and rye, affecting about 1% of the general population. The only currently approved treatment is a strict, lifelong gluten-free diet (GFD). Although strict adherence to a gluten-free diet leads to mucosal recovery in most patients, up to 20-30% of coeliac patients continue to experience persistent gastrointestinal symptoms (such as abdominal pain, bloating, diarrhoea or constipation). Furthermore, commercially prepared gluten-free products often contain higher amounts of fat, sugar and salt, and lower amounts of fibre, protein, folate and vitamins compared with gluten-containing equivalents.
Conversely, the Mediterranean diet-rich in vegetables, fruits, legumes, fish, nuts and extra-virgin olive oil-is widely recognised for its benefits on cardiovascular, metabolic and gut health, as well as quality of life, in contrast to diets rich in highly or ultra-processed foods.
This multicentre cross-sectional observational study aims to evaluate whether adult coeliac patients on a long-term strict gluten-free diet whose habitual diet more closely aligns with the Mediterranean dietary pattern are less likely to experience persistent gastrointestinal symptoms and have a better quality of life and nutritional status, and conversely whether higher consumption of highly processed foods is associated with worse symptoms, poorer quality of life and less adequate nutritional status. No dietary intervention is provided as part of the study; participants complete validated questionnaires and undergo routine anthropometric and blood assessments during a single regular outpatient follow-up visit.
Detailed description
This is a multicentre, observational, cross-sectional, no-profit study promoted and coordinated by ICS Maugeri SpA IRCCS di Pavia (Protocol Code: CTSPV40-24).
Objectives:
- Primary Objective: To evaluate the relationship between adherence to a Mediterranean diet and gastrointestinal symptoms, coeliac disease-related quality of life, and nutritional status in a population of adult coeliac patients on a strict gluten-free diet (GFD) regularly followed at participating gastroenterology outpatient clinics.
- Secondary Objective: To evaluate whether coeliac patients who consume higher amounts of highly processed (ultra-processed) foods have more persistent gastrointestinal symptoms, a worse quality of life, and a less adequate nutritional status.
Study Procedures and Observational Nature:
Patients attending routine gastroenterology outpatient follow-up visits will be invited to participate. All enrolled patients must have been on a strict GFD for at least 12 months with histological evidence of duodenal mucosal recovery on a follow-up biopsy. As clarified with the Ethics Committee (CET Lombardia 6), no specific Mediterranean diet is prescribed or provided within this study: all patients were instructed on how to follow a strict GFD at the time of coeliac disease diagnosis by expert physicians or dietitians as part of standard clinical practice, completely independently of this study. During a single study visit (with no scheduled study follow-up), the degree of adherence to the Mediterranean diet, consumption of highly processed foods, GFD compliance, gastrointestinal symptoms, and quality of life are assessed using standardized, validated questionnaires:
- PyrMDS: 15-item Pyramid-based Mediterranean Diet Score (score range 0-15).
- sQ-HPF: Short screening Questionnaire of Highly Processed Food consumption (score range 0-14 and % HPF).
- Biagi GFD Score: Gluten-free diet adherence score (score range 0-4).
- GSRS-CD (CeD-GSRS): Gastrointestinal Symptom Rating Scale including the 10 items on the Celiac Disease domains (7-point Likert scale per item).
- CDQ (CD-QOL): Celiac Disease-specific Quality of Life scale, Italian validated version (20 items on a 5-point Likert scale).
Nutritional status is evaluated through standard anthropometric measurements (height, weight, BMI, waist circumference) and routine clinical practice biochemical blood tests (hemoglobin, ferritin, folate, vitamin B12, vitamin D, calcium, albumin, ALT, AST, GGT, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, and fasting glucose).
Sample Size and Statistical Plan:
A minimum of 300 adult coeliac patients will be enrolled across 10 Italian centres over approximately 12-18 months (providing ~75% power to detect a small-to-medium effect size of Cohen's d = 0.3 at alpha = 0.05, and >80% power for Cohen's d = 0.5, while supporting multivariable regression models). Descriptive statistics, independent samples t-tests or Mann-Whitney U tests, Chi-square or Fisher's exact tests, Pearson's or Spearman's correlation coefficients, multiple linear regression models (for continuous outcomes), and multivariable logistic regression models (for dichotomous outcomes such as presence/absence of persistent gastrointestinal symptoms) will be used, adjusting for potential confounders including age, sex, duration of GFD, and comorbidities. Missing data on key variables will be addressed via multiple imputation with sensitivity analyses. Two-sided p-values < 0.05 will be considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Coeliac Disease Patients on a Long-Term Gluten-Free Diet | – | Other: Mediterranean Diet Adherence Evaluation, Other: Highly Processed Food Consumption EvaluationAdult patients (age > 18 years) with biopsy-proven coeliac disease on a strict gluten-free diet for at least 12 months and with documented duodenal mucosal recovery on follow-up biopsy, attending routine gastroenterology outpatient follow-up visits at the participating centres. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age > 18 years) with biopsy-confirmed coeliac disease on a strict gluten-free diet for at least 12 months and with histological evidence of mucosal recovery on follow-up duodenal biopsy, consecutively recruited during routine follow-up visits at 10 participating Italian gastroenterology outpatient clinics.
Key inclusion criteria (5 listed)
- Adult patients (age > 18 years)
- Diagnosis of coeliac disease based on positive IgA tissue transglutaminase / endomysial antibodies and villous atrophy on duodenal biopsy in accordance with major international guidelines
- Strict adherence to a gluten-free diet (GFD) for at least 12 months
- Evidence of duodenal mucosal recovery on a follow-up biopsy
- Regularly attending the participating gastroenterology outpatient clinics for follow-up
Key exclusion criteria (2 listed)
- Coeliac patients with poor gluten-free diet adherence and/or evidence of persistent villous atrophy on follow-up duodenal biopsy
- Patients who follow a vegetarian/vegan diet or other restrictive diets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mediterranean Diet Adherence EvaluationAlso: 15-Items Pyramid-based Mediterranean Diet Score (PyrMDS)Observational assessment of the degree of adherence to the Mediterranean dietary pattern within the patient's habitual gluten-free diet, measured using the validated 15-item Pyramid-based Mediterranean Diet Score (PyrMDS, continuous score 0 to 15 across 15 food groups: vegetables, legumes, fruits, nuts, cereals, dairy, fish, red meat, processed meat, white meat, eggs, potatoes, sweets, alcohol, and olive oil). No dietary intervention is administered. | Other | Adult Coeliac Disease Patients on a Long-Term Gluten-Free Diet |
| Highly Processed Food Consumption EvaluationAlso: Short Questionnaire of Highly Processed Food consumption (sQ-HPF), Ultra-Processed Foods (UPF) intakeObservational assessment of habitual consumption of highly processed / ultra-processed foods within the patient's gluten-free diet, measured using the validated short screening Questionnaire of Highly Processed Food consumption (sQ-HPF, score range 0 to 14 and estimated % HPF). No dietary intervention is administered. | Other | Adult Coeliac Disease Patients on a Long-Term Gluten-Free Diet |
Primary outcome
Celiac Disease Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score
Time frame: Baseline (Single cross-sectional study visit, Day 1)
Severity of gastrointestinal symptoms over the past week, measured with the 10-item CeD-GSRS. Each item is rated on a 7-point Likert scale (1 = no discomfort at all; 7 = very severe discomfort). The score is the mean of the 10 items, ranging from 1 to 7, and higher scores indicate more severe symptoms. The score will be analysed in relation to Mediterranean diet adherence (PyrMDS) and highly processed food consumption (sQ-HPF), using correlation and multivariable linear regression.
Celiac Disease-Specific Quality of Life (CD-QOL) Score
Time frame: Baseline (Single cross-sectional study visit, Day 1)
Coeliac disease-specific quality of life over the past 30 days, measured with the Italian validated 20-item CD-QOL. Items are rated on a 5-point Likert scale and the total score is transformed to a 0-100 scale, where higher scores indicate better quality of life. The score will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation and multivariable linear regression.
Pyramid-based Mediterranean Diet Score (PyrMDS)
Time frame: Baseline (Single cross-sectional study visit, Day 1)
Adherence to the Mediterranean dietary pattern, measured with the 15-item PyrMDS. The score is continuous and ranges from 0 to 15, where higher scores indicate greater adherence.
Body Mass Index (BMI)
Time frame: Baseline (Single cross-sectional study visit, Day 1)
BMI is calculated from measured weight and height (kg/m²). It will be analysed in relation to PyrMDS and sQ-HPF scores, using correlation and multivariable linear regression.
9 secondary outcomes
Short Questionnaire of Highly Processed Food Consumption (sQ-HPF) Score
Time frame: Baseline (Single cross-sectional study visit, Day 1)
Gluten-Free Diet Adherence (Biagi Score)
Time frame: Baseline (Single cross-sectional study visit, Day 1)
Percentage of Participants with Persistent Gastrointestinal Symptoms
Time frame: Baseline (Single cross-sectional study visit, Day 1)
Waist Circumference
Time frame: Baseline (Single cross-sectional study visit, Day 1)
Total Cholesterol
Time frame: Baseline (Single cross-sectional study visit, Day 1)
LDL Cholesterol
Time frame: Baseline (Single cross-sectional study visit, Day 1)
HDL Cholesterol
Time frame: Baseline (Single cross-sectional study visit, Day 1)
Triglycerides
Time frame: Baseline (Single cross-sectional study visit, Day 1)
Fasting Glucose
Time frame: Baseline (Single cross-sectional study visit, Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. IPD not shared due to privacy and data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Annalisa Schiepatti, MD, PhD principal investigator
ICS Maugeri SpA IRCCS
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease and Gluten-free Diet, run by Istituti Clinici Scientifici Maugeri SpA at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Schiepatti, MD, PhD (+39 0382592695, annalisa.schiepatti@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Celiac Disease Gastrointestinal Symptom Rating Scale (CeD-GSRS) Score (time frame: Baseline (Single cross-sectional study visit, Day 1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.