Skip to content

Change in fiber intake in children and adolescents with celiac disease before and after initiation of a gluten-free diet

Change in fiber intake in children and adolescents with celiac disease before and after initiation of a gluten-free diet - BALANZ

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037418
Enrollment
150
Registered
2025-07-17
Start date
2025-07-28
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K90.0

Interventions

Group 1: Group A: Patients with newly diagnosed celiac disease
haven't started gluten free diet yet Group 2: Group B: Patients who have already been diagnosed with celiac disease
started gluten free diet 3 months ago (10-16 weeks) Group 3: Group C: Patients who have already been diagnosed with celiac disease
started gluten free diet at least 1 year ago Group 4: Group D: Age- and gender-matched patients from the pediatric and adolescent gastroenterology consultation without celiac disease Group 5: Group E:

Sponsors

St. Josef-Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 17 Years

Inclusion criteria

Inclusion criteria: • Group A: newly diagnosed celiac disease in accordance with guidelines while consuming a gluten-containing diet (histological and/or serological) • Group B: celiac disease diagnosed in accordance with guidelines and strict gluten-free diet for 3 months (10–16 weeks) • Group C: Celiac disease diagnosed in accordance with guidelines and strict gluten-free diet for at least 12 months • Group E: Maximum age difference between siblings of 3 years

Exclusion criteria

Exclusion criteria: • Lack of consent from legal guardians and patients • Lack of language comprehension • Age under 3 years • Other accompanying chronic inflammatory bowel diseases • Diabetes mellitus type I/II • Psoriasis • Fructose malabsorption • Other concomitant diseases requiring long-term medication • Parenteral nutrition • Group A: gluten-free diet already started before inclusion in the study • Groups D and E: diagnosed celiac disease or indication of existing celiac disease, gluten-free diet

Design outcomes

Primary

MeasureTime frame
Nutrient profile based on a 7-day food and symptom diary using a nutritional calculation program (GastroSmart, Berlin, Germany) before and after initiation of a GFD, energy content of food, amount of fiber consumed, amount of soluble and insoluble fiber

Secondary

MeasureTime frame
Recording of somatic parameters (height, weight, BMI, head circumference, upper arm circumference, triceps skinfold thickness, Z-values, percentiles, BIA, Tanner stage), Recording of clinical symptoms (intestinal symptoms and stool habits), Laboratory parameters, Bone parameters, Movement protocol (MoMo-AFB), Quality-of-life questionnaire (KIDSCREEN-27 Index), Social status (MacArthur Scale)

Countries

Germany

Contacts

Public ContactAnjona Schmidt-Choudhury

Universitätsklinik für Kinder- und Jugendmedizin, St. Josef-Hospital, Bochum

anjona.schmidt-choudhury@klinikum-bochum.de+49 234 509 2611

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026