Gluten Reduction and Risk of Celiac Disease

NCT04593888 | Active Not Recruiting

• 1 other identifier: 2020-00446
• Study Type: interventional
• Target: 1,141
• Locations: 1 country
• Sites: 1

Brief Summary

Celiac disease shares many features of other autoimmune diseases such as type 1 diabetes. Recently, it was published that higher amounts of gluten intake increased the risk for celiac disease. Optimal amounts of gluten to be introduced during weaning have not yet been established. The aim is to investigate if a gluten-restricted diet (e.g. below 3 gram per day) during the first 3 years of life will reduce the risk of develop CDA and IA in genetically predisposed children by the age of 7 years. Children who screened positive for HLA DQ2/X (X is neither DQ2 nor DQ8) in the GPPAD-02 (ASTR1D \[ClinicalTrials.gov Identifier NCT03316261\]) screening will be contacted by a study nurse.

Conditions

Celiac Disease in Children; Autoimmune Diseases; type1diabetes

Keywords

gluten; diet

Outcome Measures

Primary Outcomes (1)

• Celiac disease autoimmunity (CDA)

  Children tested positive for tissue transglutaminase autoantibodies (tTGA) in two consecutive serum samples 3-6 months apart.

  from 6 months of age up until 7 years of age

Secondary Outcomes (1)

• Celiac disease (CD)

  from 6 months of age up until 7 years of age

Other Outcomes (1)

• Islet autoimmunity

  from 6 months of age up until 7 years of age

Study Arms (2)

No intervention

NO INTERVENTION

The group will be followed without any intervention, with regular visits at the research clinic.

Gluten reduced diet

EXPERIMENTAL

Subjects will follow a diet that does not exceed a daily intake of 3 gram gluten. The group will be followed with regular visits at the research clinic.

Behavioral: Gluten reduced diet

Interventions

Gluten reduced diet BEHAVIORAL

Dietary advice focusing on reducing gluten intake in children

Gluten reduced diet

Eligibility Criteria

• Age: 6 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children screened positive for HLA DQ2/X (X is neither DQ2 or DQ8)
• children who refused enrolment to the on-going study PreSiCe (ClinicalTrials.gov Identifier NCT03562221)

You may not qualify if:

• congenital chronic disorder where intervention with diet may be affected
• written informed consent from both caregivers are missing

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Clinical Research Center (CRC), Bldng 60:11

Malmo, 20502, Sweden

Location

Related Publications (5)

• Andren Aronsson C, Lee HS, Hard Af Segerstad EM, Uusitalo U, Yang J, Koletzko S, Liu E, Kurppa K, Bingley PJ, Toppari J, Ziegler AG, She JX, Hagopian WA, Rewers M, Akolkar B, Krischer JP, Virtanen SM, Norris JM, Agardh D; TEDDY Study Group. Association of Gluten Intake During the First 5 Years of Life With Incidence of Celiac Disease Autoimmunity and Celiac Disease Among Children at Increased Risk. JAMA. 2019 Aug 13;322(6):514-523. doi: 10.1001/jama.2019.10329.

  PMID: 31408136 RESULT

• Marild K, Dong F, Lund-Blix NA, Seifert J, Baron AE, Waugh KC, Taki I, Stordal K, Tapia G, Stene LC, Johnson RK, Liu E, Rewers MJ, Norris JM. Gluten Intake and Risk of Celiac Disease: Long-Term Follow-up of an At-Risk Birth Cohort. Am J Gastroenterol. 2019 Aug;114(8):1307-1314. doi: 10.14309/ajg.0000000000000255.

  PMID: 31082869 RESULT

• Vriezinga SL, Auricchio R, Bravi E, Castillejo G, Chmielewska A, Crespo Escobar P, Kolacek S, Koletzko S, Korponay-Szabo IR, Mummert E, Polanco I, Putter H, Ribes-Koninckx C, Shamir R, Szajewska H, Werkstetter K, Greco L, Gyimesi J, Hartman C, Hogen Esch C, Hopman E, Ivarsson A, Koltai T, Koning F, Martinez-Ojinaga E, te Marvelde C, Pavic A, Romanos J, Stoopman E, Villanacci V, Wijmenga C, Troncone R, Mearin ML. Randomized feeding intervention in infants at high risk for celiac disease. N Engl J Med. 2014 Oct 2;371(14):1304-15. doi: 10.1056/NEJMoa1404172.

  PMID: 25271603 RESULT

• Lionetti E, Castellaneta S, Francavilla R, Pulvirenti A, Tonutti E, Amarri S, Barbato M, Barbera C, Barera G, Bellantoni A, Castellano E, Guariso G, Limongelli MG, Pellegrino S, Polloni C, Ughi C, Zuin G, Fasano A, Catassi C; SIGENP (Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition) Working Group on Weaning and CD Risk. Introduction of gluten, HLA status, and the risk of celiac disease in children. N Engl J Med. 2014 Oct 2;371(14):1295-303. doi: 10.1056/NEJMoa1400697.

  PMID: 25271602 RESULT

• Andren Aronsson C, Lee HS, Koletzko S, Uusitalo U, Yang J, Virtanen SM, Liu E, Lernmark A, Norris JM, Agardh D; TEDDY Study Group. Effects of Gluten Intake on Risk of Celiac Disease: A Case-Control Study on a Swedish Birth Cohort. Clin Gastroenterol Hepatol. 2016 Mar;14(3):403-409.e3. doi: 10.1016/j.cgh.2015.09.030. Epub 2015 Nov 25.

  PMID: 26453955 RESULT

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Daniel Agardh, MD, PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: study participants will be randomized to either the "gluten-reduced" or "no intervention" arm on-going after enrolment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: May 5, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2035
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)