NCT02072590

Brief Summary

The main purpose of this study is to improve the diagnostics of celiac disease and reduce the need for invasive endoscopic studies in children. Further, the investigators aim to investigate the natural history and risk of complications in children with celiac disease or gluten sensitivity and to create a large scientific database.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2011

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2014

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2023

Completed
Last Updated

November 24, 2023

Status Verified

November 1, 2023

Enrollment Period

12.3 years

First QC Date

February 20, 2014

Last Update Submit

November 22, 2023

Conditions

Celiac DiseaseEosinophilic Esophagitis

Keywords

Celiac diseaseEosinophilic esophagitisEndomysial antibodiesTransglutaminase antibodiesSmall-bowel

Outcome Measures

Primary Outcomes (1)

  • Transglutaminase 2 antibodies

    Change of the transglutaminase 2 antibody levels on a gluten-free diet

    Baseline and after 3 months, 6 months and 1 year on a gluten-free diet

Secondary Outcomes (5)

  • Serum endomysial antibodies

    Baseline and after 3 months, 6 months and 1 year on a gluten-free diet

  • Visual Analog Scale

    Baseline and after 3 months, 6 months and 1 year on a gluten-free diet

  • Dietary compliance

    After 3 months, 6 months and 1 year on a gluten-free diet

  • Height

    Baseline and after 3 months, 6 months and 1 year on a gluten-free diet

  • Weight

    Baseline and after 3 months, 6 months and 1 year on a gluten-free diet

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Hospital clinic; secondary and tertiary centers

You may qualify if:

  • Suspicion of celiac disease or gluten sensitivity
  • Age below 18 years

You may not qualify if:

  • Study refusal
  • Age 18 years or more

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital

Tampere, 33520, Finland

Location

University of Medicine and Pharmacy "Carol Davila", Bucharest, Romania

Bucharest, Romania

Location

Related Publications (6)

  • Kurppa K, Ashorn M, Iltanen S, Koskinen LL, Saavalainen P, Koskinen O, Maki M, Kaukinen K. Celiac disease without villous atrophy in children: a prospective study. J Pediatr. 2010 Sep;157(3):373-80, 380.e1. doi: 10.1016/j.jpeds.2010.02.070. Epub 2010 Apr 18.

    PMID: 20400102BACKGROUND

  • Popp A, Mihu M, Munteanu M, Ene A, Dutescu M, Colcer F, Raducanu D, Laurila K, Anca I, Maki M. Prospective antibody case finding of coeliac disease in type-1 diabetes children: need of biopsy revisited. Acta Paediatr. 2013 Mar;102(3):e102-6. doi: 10.1111/apa.12117. Epub 2013 Jan 4.

    PMID: 23211000BACKGROUND

  • Taavela J, Koskinen O, Huhtala H, Lahdeaho ML, Popp A, Laurila K, Collin P, Kaukinen K, Kurppa K, Maki M. Validation of morphometric analyses of small-intestinal biopsy readouts in celiac disease. PLoS One. 2013 Oct 11;8(10):e76163. doi: 10.1371/journal.pone.0076163. eCollection 2013.

    PMID: 24146832BACKGROUND

  • Popp A, Taavela J, Arvola T, Kaukinen K, Maki M, Kurppa K. Bulb biopsies for diagnosing celiac disease in children: A prospective multicenter study using quantitative histomorphometry. J Pediatr Gastroenterol Nutr. 2026 Jan;82(1):129-136. doi: 10.1002/jpn3.70255. Epub 2025 Nov 6.

    PMID: 41195622DERIVED

  • Repo M, Lindfors K, Maki M, Huhtala H, Laurila K, Lahdeaho ML, Saavalainen P, Kaukinen K, Kurppa K. Anemia and Iron Deficiency in Children With Potential Celiac Disease. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):56-62. doi: 10.1097/MPG.0000000000001234.

    PMID: 27101536DERIVED

  • Rajalahti T, Repo M, Kivela L, Huhtala H, Maki M, Kaukinen K, Lindfors K, Kurppa K. Anemia in Pediatric Celiac Disease: Association With Clinical and Histological Features and Response to Gluten-free Diet. J Pediatr Gastroenterol Nutr. 2017 Jan;64(1):e1-e6. doi: 10.1097/MPG.0000000000001221.

    PMID: 27035377DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, intestinal mucosal biopsies

MeSH Terms

Conditions

Celiac DiseaseEosinophilic Esophagitis

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesEsophagitisEsophageal DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Kalle Kurppa, MD

    Tampere Centre for Child Health Research, University of Tampere and Tampere University hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2014

First Posted

February 26, 2014

Study Start

August 1, 2011

Primary Completion

November 21, 2023

Study Completion

November 21, 2023

Last Updated

November 24, 2023

Record last verified: 2023-11

Locations

FI(1)RO(1)