Preventing celiac disease in children through diet and probiotics
Prevention of Celiac Disease in Skåne (in Swedish - Prevention av Celiaki i Skåne)
This study tests if a gluten-free diet or daily probiotics can help prevent celiac disease in children who are at risk by the time they turn 3 years old.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 4 Months to 4 Months |
| Sex | All |
| Sponsor | Lund University Academic / other |
| Locations | 1 site (Malmö) |
| Trial ID | NCT03562221 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a gluten-free diet during the first three years of life can reduce the risk of developing celiac disease autoimmunity in genetically susceptible children. Participants are randomly assigned to one of three groups: a gluten-free diet, a daily probiotic supplement, or a placebo. The study includes regular clinical visits during the intervention phase and annual follow-ups until the age of 7 years. The primary goal is to assess the development of celiac disease autoimmunity by age 3, while secondary outcomes include the incidence of celiac disease by age 7.
Who should consider this trial
Good fit: Ideal candidates are children under 4 months of age who are genetically predisposed to celiac disease.
Not a fit: Patients with congenital chronic disorders that may interfere with dietary interventions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of celiac disease in genetically predisposed children.
How similar studies have performed: Other studies have explored dietary interventions for celiac disease prevention, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children screened positive for human leucocyte antigen (HLA) DR3-DQ2/DR3-DQ2 * Children must be enrolled to the study by 4 months of age (before gluten consumption has started). Exclusion Criteria: * Congenital chronic disorder where intervention with diet or probiotics may be affected. * Written consent from both caregivers are missing
Where this trial is running
Malmö
- Clinical Research Center (CRC), Bldng 60:11 — Malmö, Sweden (Recruiting)
Study contacts
- Principal investigator: Daniel Agardh, PhD — Lund University
- Study coordinator: Carin A Aronsson, PhD
- Email: carin.andren_aronsson@med.lu.se
- Phone: +46708876649
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.