Prevention av Autoimmunitet Med Laktobaciller

NCT04014660 | Completed

• 1 other identifier: 2019-02322
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Celiac Disease in Children; Type 1 Diabetes; Thyroid

Keywords

celiac disease autoimmunity; islet autoimmunity; auto-antibodies

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Study Arms (2)

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).

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).

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

The probiotic product consists of two different bacterial strains, L.plantarum Heal 9 and L.paracasei 8700:2

Probiotic group

Placebo DIETARY_SUPPLEMENT

The placebo supplement consists of corn starch only.

Placebo group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Clinical Research Center (CRC), Bldng 60:11

Malmo, 20502, Sweden

Location

Related Publications (7)

• 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.

  PMID: 21143526 BACKGROUND

• Falk 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.

  PMID: 17613928 BACKGROUND

• Laparra 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.

  PMID: 20052669 BACKGROUND

• Lavasani 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.

  PMID: 20126401 BACKGROUND

• Llopis 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.

  PMID: 18839424 BACKGROUND

• Wang 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.

  PMID: 15325753 BACKGROUND

• Wang 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.

  PMID: 16332321 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Thyroid Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Daniel Agardh, PhD

  Dep Clinical Sciences, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: October 1, 2019
• Primary Completion: August 1, 2024
• Study Completion: August 12, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)