Coeliac Disease Trial, Recruiting (NCT07362654)

Coeliac Disease Trial, Recruiting NCT07362654 Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud Condition: Coeliac Disease

Printed from Voxsanity (voxsanity.com.au) — NCT07362654 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Coeliac Disease

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Your child is between 8 and 14 years old at the time of joining the study
Your child has been diagnosed with celiac disease following recognised diagnostic guidelines (ESPGHAN 2020 criteria)
Your child has been strictly following a gluten-free diet for at least 18 months
Your child has shown they are sticking to the gluten-free diet, confirmed by a stool test that shows no gluten traces
Your child has had no stomach or digestive symptoms in the weeks before joining
Your child is able to swallow the gluten or placebo preparation used in the study
A parent or legal guardian has given written consent, and the child has also agreed to take part

Who may not be able to join:

Your child is considered obese based on their body weight for their age and height (BMI at or above the 95th percentile by WHO standards)
Your child has been diagnosed with inflammatory bowel disease or diabetes
Your child has an active infection or acute illness at the time of joining
Your child has a long-term condition affecting the liver, lungs, kidneys, or joints
Your child has previously had a severe reaction after accidentally eating gluten
Your child has taken steroid tablets or medicines that affect the immune system in the past 3 months
Your child has any other condition that the study doctors feel could make participation unsafe or affect the study results (confirm with trial site)

⚠️ Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 28 July 2026

This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Rafael Martín Masot, MD, PhD, Hospital Regional Universitario de Málaga / IBIMA-BIONAND

Phone: +34 951290000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07362654

Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Phase: Not Applicable

Status: Recruiting

Condition: Coeliac Disease

Trial contact: +34 951290000

More information: https://clinicaltrials.gov/study/NCT07362654

Eligibility summary (AI generated)

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Your child is between 8 and 14 years old at the time of joining the study
Your child has been diagnosed with celiac disease following recognised diagnostic guidelines (ESPGHAN 2020 criteria)
Your child has been strictly following a gluten-free diet for at least 18 months
Your child has shown they are sticking to the gluten-free diet, confirmed by a stool test that shows no gluten traces
Your child has had no stomach or digestive symptoms in the weeks before joining
Your child is able to swallow the gluten or placebo preparation used in the study
A parent or legal guardian has given written consent, and the child has also agreed to take part

Who may not be able to join:

Your child is considered obese based on their body weight for their age and height (BMI at or above the 95th percentile by WHO standards)
Your child has been diagnosed with inflammatory bowel disease or diabetes
Your child has an active infection or acute illness at the time of joining
Your child has a long-term condition affecting the liver, lungs, kidneys, or joints
Your child has previously had a severe reaction after accidentally eating gluten
Your child has taken steroid tablets or medicines that affect the immune system in the past 3 months
Your child has any other condition that the study doctors feel could make participation unsafe or affect the study results (confirm with trial site)

⚠️ Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Not Applicable

Sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Registry

ClinicalTrials.gov

Start date

7 July 2025

Est. completion

1 April 2026

Where this trial is recruiting

🇪🇸 Spain

Primary endpoints

Change in peripheral blood immune cell gene expression after controlled gluten ingestion; Change in peripheral blood T-cell receptor repertoire after controlled gluten ingestion

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov