Prevention of Celiac Disease in Skåne (PreCiSe)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03562221|
Recruitment Status : Not yet recruiting
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
This study aims to investigate the impact on being on a gluten free diet the first three years of life compared to a daily intake of a probiotic supplementation or placebo on the risk of developing celiac disease autoimmunity or celiac disease in genetically susceptible children.
Study participants will be randomly allocated to one of the three study groups before the age of 4 months and will remain in that group with the corresponding intervention during the three first years of life.
Regular visits to a study nurse and contact with study dietician will be scheduled. The dietician will support the families in keeping the correct diet intended for each study group.
|Condition or disease||Intervention/treatment||Phase|
|Celiac Disease in Children||Other: Gluten free diet Dietary Supplement: Probiotics Dietary Supplement: Placebo||Not Applicable|
The primary hypothesis to be tested is that a strictly gluten free diet during the first three years of life with a slow introduction of gluten during the follow-up period will induce tolerance to gluten. A similar hypothesis is tested if a daily supply of two different lactobacillus (LB) strains can suppress an inflammatory response to gluten in the intestine by stimulating regulatory T-cells and reduced permeability of gluten peptides in the intestine.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Prevention of Celiac Disease in Skåne (in Swedish - Prevention av Celiaki i Skåne)|
|Estimated Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||August 2024|
|Estimated Study Completion Date :||August 2027|
Experimental: Gluten free diet
Gluten free diet
Other: Gluten free diet
Controlled gluten free diet
Active Comparator: 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.
Dietary Supplement: Probiotics
Placebo Comparator: Placebo
Placebo capsules with maize starch and without any bacteria.
Dietary Supplement: Placebo
- Number of children tested positive for persistent tissue transglutaminase (tTG) autoantibodies, defined as celiac disease autoimmunity [ Time Frame: from 4 months of age up until 7 years of age ]Radioligand binding assays (RBA) will be used to measure tTG autoantibodies in serum samples collected every third months up until the age of 3 years and then annually up until the age of 7 years.
- Number of children diagnosed with celiac disease [ Time Frame: Up until 7 years of age ]A celiac disease diagnose will be defined by an intestinal biopsy showing a Marsh score of 2 or higher or by high levels of tTG autoantibodies (> 100 units) in at least 2 consecutive blood samples.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03562221
|Contact: Carin A Aronsson, PhDfirstname.lastname@example.org|
|Principal Investigator:||Daniel Agardh, PhD||Lund University|