Celiac Disease in ChildrenPreCiSeNCT03562221
Prevention of Celiac Disease in Skåne
A study testing Gluten free diet and Probiotics in people with Celiac Disease in Children, run by Lund University at 1 site in Sweden.
Trial summary
This study aims to investigate the impact of 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. Read more about this study
- Who is it for?
- Ages 4 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children
- What is being tested?
- Gluten free diet and Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteSweden
- Study dates
- 4 Dec 2018to Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- Congenital chronic disorder where intervention with diet or probiotics may be affected.
- Written consent from both caregivers are missing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Celiac Disease in Skåne (in Swedish - Prevention av Celiaki i Skåne)
This study aims to investigate the impact of 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.
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.
Read the detailed description
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.
- Conditions
- Celiac Disease in Children
- Being tested
- Gluten free diet, Probiotics, Placebo
- Keywords
- coeliac disease, celiac disease autoimmunity
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gluten free dietOther
Controlled gluten free diet
ProbioticsDietary supplement
Capsules
PlaceboDietary supplement
Capsules
| Study group | Role | What they receive |
|---|---|---|
| Gluten free diet | Experimental | Gluten free diet Receives: Other: Gluten free diet |
| Probiotics | Active comparator | 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. Receives: Dietary Supplement: Probiotics |
| Placebo | Placebo comparator | Placebo capsules with maize starch and without any bacteria. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children tested positive for persistent tissue transglutaminase (tTG) autoantibodies, defined as celiac disease autoimmunity
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.
Measured: from 4 months of age up until 7 years of age
Secondary outcomes (1)
Number of children diagnosed with celiac disease
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.
Measured: Up until 7 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start4 Dec 2018
- Primary completionAug 2027 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Agardh, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562221
- Sponsor's protocol ID
- 2018/61
- Acronym
- PreCiSe
- Status last verified
- Sep 2026
- First submitted
- 21 May 2018
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39880171
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Celiac Disease in Skåne (in Swedish - Prevention av Celiaki i Skåne)
- ClinicalTrials.gov ID
- NCT03562221
- Acronym / sponsor ID
- PreCiSe / 2018/61
- Conditions
- Celiac Disease in Children
- Keywords
- coeliac disease, celiac disease autoimmunity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the impact of 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.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gluten free diet | Experimental | Other: Gluten free dietGluten free diet |
| Probiotics | Active comparator | Dietary Supplement: ProbioticsCapsules 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. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules with maize starch and without any bacteria. |
Who may qualify
- Ages
- 4 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- Congenital chronic disorder where intervention with diet or probiotics may be affected.
- Written consent from both caregivers are missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gluten free dietControlled gluten free diet | Other | Gluten free diet |
| ProbioticsCapsules | Dietary supplement | Probiotics |
| PlaceboCapsules | Dietary supplement | Placebo |
Primary outcome
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.
1 secondary outcome
Number of children diagnosed with celiac disease
Time frame: Up until 7 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Derived from this study: PubMed 39880171Af 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.
- Individual participant dataSharing planned: No
Related trials for Celiac Disease in Children
Recruiting
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Celiac Disease in Children, Nutrition Disorder, Child
Enrolling by invitation
Assessment of Nutritional Status in Celiac Disease Using Muscle Ultrasound in Pediatric Patients.
Celiac Disease in Children, Nutritional Assessment
Active, not recruiting
Celiac Disease in Childhood-Adulthood Transition
Celiac Disease, Celiac Disease in Children
Enrolling by invitation
Immune Responses to Gluten
Celiac Disease, Malabsorption Syndromes
RecruitingObservational study
Effect of Adherence to a Gluten-Free Diet on Cognitive and Motor Dual-Task Performance in Adolescents Diagnosed With Celiac Disease
Celiac Disease in Children, Celiac Disease in Adolescents
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Agardh, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gluten free diet and Probiotics in people with Celiac Disease in Children, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.