CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 202 enrolled
Drug / intervention
Probiotic +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04014660
NCT04014660N/ACompleted

Prevention av Autoimmunitet Med Laktobaciller (in English; Prevention of Autoimmunity With Lactobacilli)

Lund University·interventional·Posted Jul 10, 2019·Updated Apr 13, 2026

In Brief

A clinical study evaluating Probiotic and Placebo for Celiac Disease in Children and 2 related conditions. Completed, enrolled 202 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 10, 2019
Enrollment StartOct 1, 2019
Primary CompletionAug 1, 2024
Study CompletionAug 12, 2025
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.0 years ago

Interventions

Probioticdietary

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

Placebodietary

The placebo supplement consists of corn starch only.