Coeliac Disease Trial, Recruiting NCT07563582 Sponsor: Istituto Giannina Gaslini Condition: Coeliac Disease
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Coeliac Disease Trial, Recruiting

NCT07563582
Recruiting Not Applicable

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:

  • You have been diagnosed with celiac disease following current European guidelines, either based on symptoms or a tissue biopsy, and have been found to have low iron levels or iron-deficiency anemia.
  • You were between 8 and 18 years old (inclusive) when you were diagnosed with celiac disease.
  • You have not taken iron supplements by mouth in the 30 days before diagnosis, or iron given through a drip (intravenously) in the 90 days before diagnosis.
  • You had not already started a gluten-free diet before your diagnosis was made.
  • Any other possible causes of your anemia have been ruled out by a doctor.
  • You (and your parent or legal guardian) are willing and able to understand what the study involves and take part.
  • Both parents or legal guardians have given their written agreement (informed consent) for you to take part.

Who may not be able to join:

  • You have only a "potential" celiac disease diagnosis rather than a confirmed one.
  • Your hemoglobin (a measure of red blood cells) is below 8 g/dL at the screening visit (confirm with trial site).
  • You have another known cause of anemia, a blood disorder affecting hemoglobin, or a blood clotting disorder.
  • You have had active bleeding, surgery, or a serious injury in the last 6 months.
  • You have another inflammatory condition, cancer, or a confirmed food allergy driven by the immune system (IgE-mediated).
  • You have a genetic syndrome or abnormal blood vessel formations in your body.
  • You are pregnant or breastfeeding.
  • You have a known or suspected allergy or sensitivity to the study product or any of its ingredients.
  • You have taken iron supplements by mouth in the 30 days before diagnosis, or iron given through a drip in the 90 days before diagnosis.
  • You have taken part in another clinical trial or used another experimental treatment within 30 days before joining this study, or plan to during the study.
  • Your doctor believes there is any other reason that makes you unsuitable for this study.

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

Phone: +3901056362350

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.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Istituto Giannina Gaslini
Registry
ClinicalTrials.gov
Start date
23 December 2025
Est. completion
1 March 2027

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

Time to normalization of iron status

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