Celiac Disease Prevention With Probiotics

Celiac Disease in Children Clinical Trial

— CiPP  

Official title:

Celiac Disease Prevention With Probiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03176095
• Other study ID #: 2011/335
• Status: Completed
• Phase: N/A
• Start date: March 1, 2012
• Est. completion date: August 30, 2015

Study information

• Verified date: November 2021
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background/Aim: Celiac disease is a common immune-mediated disorder, and the only currently available treatment is a gluten-free diet. Recent studies have shown several probiotics to carry properties that might positively influence the immunological activity in celiac patients.

The aim of the present study is to investigate how daily consumption of probiotics would affect levels of tissue transglutaminase autoantibodies (tTGA), markers of celiac disease autoimmunity in the periphery, as compared to placebo in children at genetic risk for celiac disease.

Methods: Between 2012 and 2015, 90 children were recruited from two ongoing prospective celiac disease screening studies at the Skåne University Hospital, Sweden. Participants were randomized to either daily consumption of 2 lactobacilli strains or placebo for the duration of 6 months.

Blood samples were drawn at 0, 3 and 6 months and analyzed for both IgA-tTGA and IgG-tTGA using radioligand binding assays.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 30, 2015
• Est. primary completion date: August 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• Carrier of any of the HLA-types DQ2 and/or DQ8 associated with celiac disease.

• Screened positive for tissue transglutaminase autoantibodies (tTGA) in at least 2 consecutive blood draws (<30U/ml).

• No celiac disease diagnose

• Currently on a normal gluten-containing diet

Exclusion Criteria:

• Screened positive for Type 1 diabetes associated autoantibodies (GADA, IAA, IA-2A, ZnT8A).

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Disease in Children

Intervention

Dietary Supplement:
• Probiotic

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

References & Publications (4)

Auricchio R, Troncone R. Can Celiac Disease Be Prevented? Front Immunol. 2021 May 14;12:672148. doi: 10.3389/fimmu.2021.672148. eCollection 2021. Review. — View Citation

Håkansson Å, Andrén Aronsson C, Brundin C, Oscarsson E, Molin G, Agardh D. Effects of Lactobacillus plantarum and Lactobacillus paracasei on the Peripheral Immune Response in Children with Celiac Disease Autoimmunity: A Randomized, Double-Blind, Placebo-C — View Citation

Jedwab CF, Roston BCMB, Toge ABFS, Echeverria IF, Tavares GOG, Alvares MA, Rullo VEV, Oliveira MRM. The role of probiotics in the immune response and intestinal microbiota of children with celiac disease: a systematic review. Rev Paul Pediatr. 2021 Sep 1;40:e2020447. doi: 10.1590/1984-0462/2022/40/2020447. eCollection 2021. English, Portuguese. — View Citation

Oscarsson E, Håkansson Å, Andrén Aronsson C, Molin G, Agardh D. Effects of Probiotic Bacteria Lactobacillaceae on the Gut Microbiota in Children With Celiac Disease Autoimmunity: A Placebo-Controlled and Randomized Clinical Trial. Front Nutr. 2021 Jun 25; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue transglutaminase autoantibodies (tTGA)	To study levels of tTGA in children with ongoing celiac disease autoimmunity	6 months