---
title: Treatment of Screen-detected Celiac Disease
nct_id: NCT01116505
overall_status: COMPLETED
phase: NA
sponsor: Tampere University Hospital
study_type: INTERVENTIONAL
primary_condition: Celiac Disease
countries: Finland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01116505.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01116505"
ct_last_update_post_date: 2012-08-27
last_seen_at: "2026-05-12T07:07:13.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Treatment of Screen-detected Celiac Disease

**Official Title:** Treatment of Screen-detected Celiac Disease in Adults

**NCT ID:** [NCT01116505](https://clinicaltrials.gov/study/NCT01116505)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Tampere University Hospital
- **Conditions:** Celiac Disease
- **Start Date:** 2008-08
- **Completion Date:** 2012-08
- **CT.gov Last Update:** 2012-08-27

## Brief Summary

The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.

## Detailed Description

Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Positive endomysial antibodies
* Adults

Exclusion Criteria:

* Previous celiac disease diagnosis
* Significant clinical symptoms
* Suspicion of any serious celiac disease-associated complication
* Suspected or diagnosed severe illness other than celiac disease
* Consuming oral corticosteroids or immune suppressants
* Marked laboratory abnormalities
```

## Arms

- **gluten-containing diet** (NO_INTERVENTION)
- **Active comparator, gluten-free diet** (ACTIVE_COMPARATOR)

## Interventions

- **Gluten-free diet** (DIETARY_SUPPLEMENT) — gluten-containing cereals removed from diet

## Primary Outcomes

- **Small-bowel mucosal morphology and inflammation** _(time frame: One year)_

## Secondary Outcomes

- **Endomysial antibodies** _(time frame: one year)_
- **Tissue transglutaminase antibodies** _(time frame: one year)_
- **Antibodies to deamidated gliadin** _(time frame: one year)_
- **Intestinal tissue transglutaminase-specific IgA deposits** _(time frame: one year)_
- **Bone mineral density** _(time frame: one year)_
- **Body composition** _(time frame: one year)_
- **Health-related quality of life** _(time frame: one year)_
- **Laboratory parameters** _(time frame: one year)_

## Locations (1)

- Pediatric Research Centre, Tampere University Hospital and University of Tampere, Tampere, Pirkanmaa, Finland

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pediatric research centre, tampere university hospital and university of tampere|tampere|pirkanmaa|finland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01116505.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01116505*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*