K90.0
Conditions
Interventions
Group 1: Relaxed gluten-free diet (rGFD) – cross-contamination up to 200 ppm (Median) tolerated: Single educational video training (approx. 60 minutes) at baseline, weekly food diary over 24 weeks.
Bo
Studerus et al., 2026) identified a category of foods and situations that individuals with celiac disease commonly avoid based on historical assumption rather than measurement data. Participants in th
Sponsors
Schweizer Zöliakie Zantrum am GastroZentrum Hirslanden
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Signed informed consent Men or women between 18 and 80 years of age, inclusively Documented initial biopsy-proven diagnosis of celiac disease or, in case of missing histological documentation, TG2-IgA >10 times the upper limit of normal at diagnosis at least 12 months prior to baseline visit Adherence to a gluten-free diet for at least 12 months prior to baseline visit Biopsy showing Vh:Cd ratio =2.0:1 from distal duodenal biopsies at baseline visit Willingness to follow usual dietary patterns during the trial Willingness to maintain the assigned gluten-free dietary approach throughout participation Willingness to keep a weekly quantitative record of eating behaviours regarding cross-contamination with gluten
Exclusion criteria
Exclusion criteria: Seronegative celiac disease, as celiac-specific antibody measurement serves as safety monitoring Symptoms related to celiac disease with a symptom score >20 points on the Celiac Symptom Index (CSI) in the 4 weeks prior to screening Concomitant intestinal diseases including Crohn's disease, ulcerative colitis, inflammatory bowel disease, severe irritable bowel syndrome, microscopic colitis, small intestinal bacterial overgrowth, exocrine pancreatic insufficiency, or other active intestinal diseases that might interfere with symptom assessment Concomitant metabolic disorders including obesity (BMI >35), diabetes mellitus Type 1 or Type 2 with insulin therapy Concomitant mental disorders including major depression, eating disorders, or anxiety disorders that might interfere with eating habits Existing or intended pregnancy or breast-feeding Close affiliation with the investigator or financial dependence on study site personnel Institutionalisation due to legal or regulatory order Participation in another clinical trial involving modified gluten-free diet or celiac disease-related interventions within 12 months prior to screening Previous enrolment in the current investigation Suspected non-compliance due to alcohol or drug abuse or behavioural concerns during screening Inability to follow investigation procedures due to language barriers, psychological disorders, or dementia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Villus height to crypt depth ratio (Vh:Cd) – histomorphometric analysis by blinded pathologist using calibrated digital microscopy on duodenal biopsies; assessed at baseline (T0) and week 24 (T4). | — |
Secondary
| Measure | Time frame |
|---|---|
| Tissue transglutaminase IgA antibody (tTG-IgA) in blood – ELISA; assessed at T0, T1 (week 6), T2 (week 12), T3 (week 18), T4 (week 24). Modified Marsh-Oberhuber classification and intraepithelial lymphocyte count (IEL) – histology; assessed at T0 and T4. Gluten immunogenic peptides (GIP) in stool – validated immunoassay; assessed at T1, T2, T3, T4. Anti-human tissue transglutaminase secretory IgA antibodies (anti-htTG sIgA) in stool – immunoassay; assessed at T1, T2, T3, T4. Symptoms – Celiac Symptom Index (CSI, Leffler et al., 2009); assessed at T0, T1, T2, T3, T4. Acceptability – Acceptability of Intervention Measure (AIM, Weiner et al., 2017; German version Kien et al., 2021); assessed at T0, T2, T4. Food-related quality of life, anxiety about gluten ingestion, willingness to take risks – visual analogue scale (VAS, 0–100 mm) for each; assessed at T0, T1, T2, T3, T4. Estimated gluten intake – structured weekly food diary; continuously over 24 weeks. | — |
Countries
Switzerland
Contacts
Public ContactJonas Zeitz
Schweizer ZöliakieZentrum am GastroZentrum Hirslanden
Outcome results
None listed