Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
220 participants
INTERVENTIONAL
2018-12-04
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is a three-arm (1:1:1) randomized trial where study participants are randomly allocated to one of the three study groups before the age of 4 months. Regular clinical visits (4 times/year) during the intervention phase and yearly there after, up to the age of 7 years.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Celiac Disease Prevention With Probiotics
NCT03176095
Gluten Reduction and Risk of Celiac Disease
NCT04593888
Glutenfree, Gut Microbiota and Metabolic Regulation
NCT05135923
Serological Identification of Celiac Disease in Kids
NCT03966625
Risk of Celiac Disease and Age at Gluten Introduction
NCT00639444
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The secondary hypothesis tested is that celiac disease can not be prevented, but the onset of the disease will be delayed in children returning to a gluten-containing diet after the intervention period (gluten free diet) or probiotic treatment) during the first three years of life. The intervention period is 3 years and the follow-up period is further 4 years.
The primary aim is to study the proportion of children who develop celiac disease autoimmunity and progression to celiac disease by the age of 3 years. Secondary aim is to study the proportion of children who developed celiac disease at the age of 7 years.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Gluten free diet
Gluten free diet
Gluten free diet
Controlled gluten free diet
Probiotics
Capsules with a combination of two probiotic bacteria with maize starch as excipient and at a total dose of 10(10) colony forming units (CFU)/capsule.
Probiotics
Capsules
Placebo
Placebo capsules with maize starch and without any bacteria.
Placebo
Capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Gluten free diet
Controlled gluten free diet
Probiotics
Capsules
Placebo
Capsules
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Children must be enrolled to the study by 4 months of age (before gluten consumption has started).
Exclusion Criteria
* Written consent from both caregivers are missing
4 Months
4 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lund University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel Agardh, PhD
Role: PRINCIPAL_INVESTIGATOR
Lund University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Research Center (CRC), Bldng 60:11
Malmo, , Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Af Segerstad EMH, Ericson-Hallstrom E, Bokstrom A, Armeni M, Savolainen O, Andren Aronsson C. Plasma Alkylresorcinols Is an Objective Biomarker for Gluten Intake in Young Children. J Nutr. 2025 Mar;155(3):985-993. doi: 10.1016/j.tjnut.2025.01.020. Epub 2025 Jan 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018/61
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.