Celiac Disease in ChildrenPALNCT04014660
Prevention av Autoimmunitet Med Laktobaciller
A study testing Probiotic in people with Celiac Disease in Children and Type 1 Diabetes, run by Lund University at 1 site in Sweden.
Trial summary
The incidence of autoimmune diseases (celiac disease, type 1 diabetes, thyroid disease) have increased over the past 30 years. Although most autoimmune diseases have a strong link to different risk genes, the rapid increase is thought to be due to changes in environmental factors. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease in Children, Type 1 Diabetes, Thyroid
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2019to 12 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Screened persistent positive for any of the auto-antibodies associated with celiac disease (tTGa), type 1 diabetes (IAA, GADA, IA-2A, Zn-T8) and/or thyroid disease (TPOA)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention av Autoimmunitet Med Laktobaciller (in English; Prevention of Autoimmunity With Lactobacilli)
The incidence of autoimmune diseases (celiac disease, type 1 diabetes, thyroid disease) have increased over the past 30 years. Although most autoimmune diseases have a strong link to different risk genes, the rapid increase is thought to be due to changes in environmental factors. There is currently no cure for autoimmune diseases, but the treatment is lifelong and either involves suppressing the inflammation and / or substituting the organs that are affected to maintain vital functions. Being able to predict who is affected and identifying factors that trigger autoimmunity is necessary for developing new treatment methods that prevent the occurrence of autoimmune diseases. The bacterial flora's composition in the gut can affect both the intestinal barrier properties and the immune system's response to various dietary components. An adverse composition of the intestinal flora can activate parts of the immune system that are involved in chronic inflammation in celiac disease and inflammatory bowel disease. Probiotics are defined as living microorganisms which, when ingested in sufficient amounts, produce a health effect (FAO / WHO). The aim of the study is to investigate whether a daily oral intake of a mixture of L.paracasei and L.plantarum can affect the autoimmune process in children who are screened positive for any of the autoantibodies associated with development of celiac disease, type 1 diabetes and / or thyroid disease. Our hypothesis is that lactobacilli can directly regulate the autoimmune process in the small intestinal mucosa by stimulating regulatory T-cells, but also by affecting the permeability of the small intestinal mucosa by of antigen that stimulates specific T-cells.
Read the detailed description
The incidence of autoimmune diseases (celiac disease, type 1 diabetes, thyroid disease) have increased over the past 30 years. Although most autoimmune diseases have a strong link to different risk genes, the rapid increase is thought to be due to changes in environmental factors. There is currently no cure for autoimmune diseases, but the treatment is lifelong and either involves suppressing the inflammation and / or substituting the organs that are affected to maintain vital functions. Being able to predict who is affected and identifying factors that trigger autoimmunity is necessary for developing new treatment methods that prevent the occurrence of autoimmune diseases.
The bacterial flora's composition in the gut can affect both the intestinal barrier properties and the immune system's response to various dietary components. An adverse composition of the intestinal flora can activate parts of the immune system that are involved in chronic inflammation in celiac disease and inflammatory bowel disease.
Probiotics are defined as living microorganisms which, when ingested in sufficient amounts, produce a health effect (FAO / WHO). Certain probiotic strains has been used to hamper pro-inflammatory immune system triggered by gluten protein in conjunction with celiac disease. Earlier studies have shown that Lactobacillus reduced the permeability in the small intestinal mucosa. But to our knowledge, no randomized clinical trials have tested the effect on probiotic supplementation and development of autoimmune disease such as celiac disease.
The aim of the study is to investigate whether a daily oral intake of a mixture of L.paracasei and L.plantarum can affect the autoimmune process in children who are screened positive for any of the autoantibodies associated with development of celiac disease, type 1 diabetes and / or thyroid disease. Our hypothesis is that lactobacilli can directly regulate the autoimmune process in the small intestinal mucosa by stimulating regulatory T-cells, but also by affecting the permeability of the small intestinal mucosa by of antigen that stimulates specific T-cells.
The aims of this study are:
- will supplementation of L.paracasei and L.plantarum during a 12 month period compared to placebo increase the levels of regulatory T-cells (CD4+CD25+) and decrease B-cells and/or NK-cells in children and adolescents screened persistent positive with auto-antibodies associated with celiac disease, type 1 diabetes and / or thyroid disease?
- will supplementation of L.paracasei and L.plantarum during a 12 month period compared to placebo increase the abundance of bacteroides in gut and oral cavity in children and adolescents screened persistent positive with auto-antibodies associated with celiac disease, type 1 diabetes and / or thyroid disease?
- will supplementation of L.paracasei and L.plantarum during a 12 month period compared to placebo lower the levels of auto-antibodies associated with celiac disease, type 1 diabetes and / or thyroid disease in children and adolescents with persistent positive auto-antibodies.
A total of 200 children genetically at-risk for celiac disease, type 1 diabetes and thyroid disease who are persistent positive for any of the following auto-antibodies will be invited to the study.
Participants who signed a informed consent will be randomized (double blinded) into the probiotic or placebo group. A venous blood sample, saliva- and feces sample will be collected at every clinic visit, 3 months apart (0, 3, 6, 9 and 12 months). A short questionnaire collecting information about illnesses, medication- and dietary supplement use, food habits, and demographic factors will be used.
Blood sample will be analyzed for auto-antibodies (tTGA, GADA, IA-2A, IAA, Zn-T8A, and TPOA). FACS analyses will be used for a panel of inflammatory markers (CD3, CD4, CD8, CD25 etc). Feces- and saliva samples will be analysed using T-RFLP (PCR) of 16S rRNA.
The benefit if this study are the increased knowledge about specific probiotics strains impact on autoimmunity in genetically at-risk children, and hopes of reducing the risk for developing autoimmune diseases as celiac disease, type 1 diabetes and thyroid disease.
- Conditions
- Celiac Disease in Children, Type 1 Diabetes, Thyroid
- Being tested
- Probiotic, Placebo
- Keywords
- celiac disease autoimmunity, islet autoimmunity, auto-antibodies
- Medical subject headings
- Diabetes Mellitus, Type 1, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The probiotic product consists of two different bacterial strains, L.plantarum Heal 9 and L.paracasei 8700:2
PlaceboDietary supplement
The placebo supplement consists of corn starch only.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | The participants in this group are provided with a dietary supplement (capsules) containing freeze dried bacteria (active lactobacilli culture) mixed with corn starch, for daily intake (1 capsule per day). Receives: Dietary Supplement: Probiotic |
| Placebo group | Placebo comparator | The participants in this group are provided with a dietary supplement (capsules) containing corn starch only, for daily intake (1 capsule per day). Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autoimmunity
To study levels of auto-antibodies (tTGA, GADA, IA-2, IAA, ZnT8a, TPOA) genetically at-risk children. (Blood sample will be analyzed for auto-antibodies (tTGA, GADA, IA-2A, IAA, Zn-T8A, and TPOA)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Oct 2019
- Primary completion1 Aug 2024
- Study completion12 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Celiac Disease in ChildrenStudies of the same condition, open and under way.
- 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Agardh, PhD, Principal investigator, Dep Clinical Sciences, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014660
- Sponsor's protocol ID
- 2019-02322
- Other IDs
- 2019
- Acronym
- PAL
- Status last verified
- Apr 2026
- First submitted
- 8 Jul 2019
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eun CS, Kim YS, Han DS, Choi JH, Lee AR, Park YK. Lactobacillus casei prevents impaired barrier function in intestinal epithelial cells. APMIS. 2011 Jan;119(1):49-56. doi: 10.1111/j.1600-0463.2010.02691.x. Epub 2010 Oct 25.
PubMed 21143526Falk A, Olsson C, Ahrne S, Molin G, Adawi D, Jeppsson B. Ileal pelvic pouch microbiota from two former ulcerative colitis patients, analysed by DNA-based methods, were unstable over time and showed the presence of Clostridium perfringens. Scand J Gastroenterol. 2007 Aug;42(8):973-85. doi: 10.1080/00365520701204238.
PubMed 17613928Laparra JM, Sanz Y. Bifidobacteria inhibit the inflammatory response induced by gliadins in intestinal epithelial cells via modifications of toxic peptide generation during digestion. J Cell Biochem. 2010 Mar 1;109(4):801-7. doi: 10.1002/jcb.22459.
PubMed 20052669Lavasani S, Dzhambazov B, Nouri M, Fak F, Buske S, Molin G, Thorlacius H, Alenfall J, Jeppsson B, Westrom B. A novel probiotic mixture exerts a therapeutic effect on experimental autoimmune encephalomyelitis mediated by IL-10 producing regulatory T cells. PLoS One. 2010 Feb 2;5(2):e9009. doi: 10.1371/journal.pone.0009009.
PubMed 20126401Llopis M, Antolin M, Carol M, Borruel N, Casellas F, Martinez C, Espin-Basany E, Guarner F, Malagelada JR. Lactobacillus casei downregulates commensals' inflammatory signals in Crohn's disease mucosa. Inflamm Bowel Dis. 2009 Feb;15(2):275-83. doi: 10.1002/ibd.20736.
PubMed 18839424Wang M, Ahrne S, Antonsson M, Molin G. T-RFLP combined with principal component analysis and 16S rRNA gene sequencing: an effective strategy for comparison of fecal microbiota in infants of different ages. J Microbiol Methods. 2004 Oct;59(1):53-69. doi: 10.1016/j.mimet.2004.06.002.
PubMed 15325753Wang M, Ahrne S, Jeppsson B, Molin G. Comparison of bacterial diversity along the human intestinal tract by direct cloning and sequencing of 16S rRNA genes. FEMS Microbiol Ecol. 2005 Oct 1;54(2):219-31. doi: 10.1016/j.femsec.2005.03.012.
PubMed 16332321
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention av Autoimmunitet Med Laktobaciller (in English; Prevention of Autoimmunity With Lactobacilli)
- ClinicalTrials.gov ID
- NCT04014660
- Acronym / sponsor ID
- PAL / 2019-02322
- Conditions
- Celiac Disease in Children, Type 1 Diabetes, Thyroid
- Keywords
- celiac disease autoimmunity, islet autoimmunity, auto-antibodies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 12 Aug 2025 (actual)
- First posted
- 10 Jul 2019 (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.
The incidence of autoimmune diseases (celiac disease, type 1 diabetes, thyroid disease) have increased over the past 30 years. Although most autoimmune diseases have a strong link to different risk genes, the rapid increase is thought to be due to changes in environmental factors. There is currently no cure for autoimmune diseases, but the treatment is lifelong and either involves suppressing the inflammation and / or substituting the organs that are affected to maintain vital functions. Being able to predict who is affected and identifying factors that trigger autoimmunity is necessary for developing new treatment methods that prevent the occurrence of autoimmune diseases. The bacterial flora's composition in the gut can affect both the intestinal barrier properties and the immune system's response to various dietary components. An adverse composition of the intestinal flora can activate parts of the immune system that are involved in chronic inflammation in celiac disease and inflammatory bowel disease. Probiotics are defined as living microorganisms which, when ingested in sufficient amounts, produce a health effect (FAO / WHO). The aim of the study is to investigate whether a daily oral intake of a mixture of L.paracasei and L.plantarum can affect the autoimmune process in children who are screened positive for any of the autoantibodies associated with development of celiac disease, type 1 diabetes and / or thyroid disease. Our hypothesis is that lactobacilli can directly regulate the autoimmune process in the small intestinal mucosa by stimulating regulatory T-cells, but also by affecting the permeability of the small intestinal mucosa by of antigen that stimulates specific T-cells.
Detailed description
The incidence of autoimmune diseases (celiac disease, type 1 diabetes, thyroid disease) have increased over the past 30 years. Although most autoimmune diseases have a strong link to different risk genes, the rapid increase is thought to be due to changes in environmental factors. There is currently no cure for autoimmune diseases, but the treatment is lifelong and either involves suppressing the inflammation and / or substituting the organs that are affected to maintain vital functions. Being able to predict who is affected and identifying factors that trigger autoimmunity is necessary for developing new treatment methods that prevent the occurrence of autoimmune diseases.
The bacterial flora's composition in the gut can affect both the intestinal barrier properties and the immune system's response to various dietary components. An adverse composition of the intestinal flora can activate parts of the immune system that are involved in chronic inflammation in celiac disease and inflammatory bowel disease.
Probiotics are defined as living microorganisms which, when ingested in sufficient amounts, produce a health effect (FAO / WHO). Certain probiotic strains has been used to hamper pro-inflammatory immune system triggered by gluten protein in conjunction with celiac disease. Earlier studies have shown that Lactobacillus reduced the permeability in the small intestinal mucosa. But to our knowledge, no randomized clinical trials have tested the effect on probiotic supplementation and development of autoimmune disease such as celiac disease.
The aim of the study is to investigate whether a daily oral intake of a mixture of L.paracasei and L.plantarum can affect the autoimmune process in children who are screened positive for any of the autoantibodies associated with development of celiac disease, type 1 diabetes and / or thyroid disease. Our hypothesis is that lactobacilli can directly regulate the autoimmune process in the small intestinal mucosa by stimulating regulatory T-cells, but also by affecting the permeability of the small intestinal mucosa by of antigen that stimulates specific T-cells.
The aims of this study are:
- will supplementation of L.paracasei and L.plantarum during a 12 month period compared to placebo increase the levels of regulatory T-cells (CD4+CD25+) and decrease B-cells and/or NK-cells in children and adolescents screened persistent positive with auto-antibodies associated with celiac disease, type 1 diabetes and / or thyroid disease?
- will supplementation of L.paracasei and L.plantarum during a 12 month period compared to placebo increase the abundance of bacteroides in gut and oral cavity in children and adolescents screened persistent positive with auto-antibodies associated with celiac disease, type 1 diabetes and / or thyroid disease?
- will supplementation of L.paracasei and L.plantarum during a 12 month period compared to placebo lower the levels of auto-antibodies associated with celiac disease, type 1 diabetes and / or thyroid disease in children and adolescents with persistent positive auto-antibodies.
A total of 200 children genetically at-risk for celiac disease, type 1 diabetes and thyroid disease who are persistent positive for any of the following auto-antibodies will be invited to the study.
Participants who signed a informed consent will be randomized (double blinded) into the probiotic or placebo group. A venous blood sample, saliva- and feces sample will be collected at every clinic visit, 3 months apart (0, 3, 6, 9 and 12 months). A short questionnaire collecting information about illnesses, medication- and dietary supplement use, food habits, and demographic factors will be used.
Blood sample will be analyzed for auto-antibodies (tTGA, GADA, IA-2A, IAA, Zn-T8A, and TPOA). FACS analyses will be used for a panel of inflammatory markers (CD3, CD4, CD8, CD25 etc). Feces- and saliva samples will be analysed using T-RFLP (PCR) of 16S rRNA.
The benefit if this study are the increased knowledge about specific probiotics strains impact on autoimmunity in genetically at-risk children, and hopes of reducing the risk for developing autoimmune diseases as celiac disease, type 1 diabetes and thyroid disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Dietary Supplement: ProbioticThe participants in this group are provided with a dietary supplement (capsules) containing freeze dried bacteria (active lactobacilli culture) mixed with corn starch, for daily intake (1 capsule per day). |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThe participants in this group are provided with a dietary supplement (capsules) containing corn starch only, for daily intake (1 capsule per day). |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Screened persistent positive for any of the auto-antibodies associated with celiac disease (tTGa), type 1 diabetes (IAA, GADA, IA-2A, Zn-T8) and/or thyroid disease (TPOA)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ProbioticThe probiotic product consists of two different bacterial strains, L.plantarum Heal 9 and L.paracasei 8700:2 | Dietary supplement | Probiotic group |
| PlaceboThe placebo supplement consists of corn starch only. | Dietary supplement | Placebo group |
Primary outcome
Autoimmunity
Time frame: 12 months
To study levels of auto-antibodies (tTGA, GADA, IA-2, IAA, ZnT8a, TPOA) genetically at-risk children. (Blood sample will be analyzed for auto-antibodies (tTGA, GADA, IA-2A, IAA, Zn-T8A, and TPOA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 21143526Eun CS, Kim YS, Han DS, Choi JH, Lee AR, Park YK. Lactobacillus casei prevents impaired barrier function in intestinal epithelial cells. APMIS. 2011 Jan;119(1):49-56. doi: 10.1111/j.1600-0463.2010.02691.x. Epub 2010 Oct 25.
- Background: PubMed 17613928Falk A, Olsson C, Ahrne S, Molin G, Adawi D, Jeppsson B. Ileal pelvic pouch microbiota from two former ulcerative colitis patients, analysed by DNA-based methods, were unstable over time and showed the presence of Clostridium perfringens. Scand J Gastroenterol. 2007 Aug;42(8):973-85. doi: 10.1080/00365520701204238.
- Background: PubMed 20052669Laparra JM, Sanz Y. Bifidobacteria inhibit the inflammatory response induced by gliadins in intestinal epithelial cells via modifications of toxic peptide generation during digestion. J Cell Biochem. 2010 Mar 1;109(4):801-7. doi: 10.1002/jcb.22459.
- Background: PubMed 20126401Lavasani S, Dzhambazov B, Nouri M, Fak F, Buske S, Molin G, Thorlacius H, Alenfall J, Jeppsson B, Westrom B. A novel probiotic mixture exerts a therapeutic effect on experimental autoimmune encephalomyelitis mediated by IL-10 producing regulatory T cells. PLoS One. 2010 Feb 2;5(2):e9009. doi: 10.1371/journal.pone.0009009.
- Background: PubMed 18839424Llopis M, Antolin M, Carol M, Borruel N, Casellas F, Martinez C, Espin-Basany E, Guarner F, Malagelada JR. Lactobacillus casei downregulates commensals' inflammatory signals in Crohn's disease mucosa. Inflamm Bowel Dis. 2009 Feb;15(2):275-83. doi: 10.1002/ibd.20736.
- Background: PubMed 15325753Wang M, Ahrne S, Antonsson M, Molin G. T-RFLP combined with principal component analysis and 16S rRNA gene sequencing: an effective strategy for comparison of fecal microbiota in infants of different ages. J Microbiol Methods. 2004 Oct;59(1):53-69. doi: 10.1016/j.mimet.2004.06.002.
- Background: PubMed 16332321Wang M, Ahrne S, Jeppsson B, Molin G. Comparison of bacterial diversity along the human intestinal tract by direct cloning and sequencing of 16S rRNA genes. FEMS Microbiol Ecol. 2005 Oct 1;54(2):219-31. doi: 10.1016/j.femsec.2005.03.012.
- Individual participant dataSharing planned: No
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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
Dep Clinical Sciences, 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 Probiotic in people with Celiac Disease in Children and Type 1 Diabetes, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Autoimmunity (time frame: 12 months). 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 NCT04014660, which also lists 7 linked publications.
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 13 Apr 2026.