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Iron infusions may boost gut healing in celiac disease

NCT ID NCT05114278

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial investigates whether adding intravenous iron to standard oral iron supplements can help heal intestinal damage in people with celiac disease who have iron deficiency and gut atrophy. Participants receive either intravenous iron infusions plus oral iron, or oral iron alone. The goal is to see if the IV approach leads to full recovery of the intestinal lining.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ferinject (intravenous iron) plus oral iron
What this could lead to
If it works, this could show that intravenous iron helps heal intestinal damage faster in celiac disease patients who don't absorb iron well from pills alone.
What could go wrong
This is a small, early-phase trial with only one participant enrolled, so results may not apply broadly. Intravenous iron carries risks like allergic reactions or infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1 person

The number who actually took part.

Started

Jul 2022

Finished

Jul 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients free of mental illness, able to sign consent and \>18year * Celiac disease confirmed by presence of serum celiac antibodies and villous atrophy on intestinal biopsy before starting gluten free diet (GFD) * Intestinal villous atrophy on duodenal biopsy (performed within 1 month) showing villous atrophy * Patient under GFD or starting GFD with strict compliance * Hemoglobin level (Hb) \<12g/dL \& Hb\>8g/dL * Well tolerated anemia * Iron deficiency defined by: serum iron level \< 11 µmol/L, ferritinemia \< 20µg/L and/or transferrin saturation index \<0.2 Exclusion Criteria: * Patient not able to sign, mental illness, pregnancy * Complicated celiac disease: intestinal malignancies * Severe anemia (Hb \<8g/dL) and/or poorly tolerated anemia requiring systematic iron IV supplementation or blood transfusion * Serious severe disease having short-term prognostic implication * Contraindication to intravenous iron infusion: known drug allergy * Pregnant or breastfeeding women * Participation in another interventional trial * Patients treated by steroids, immunosuppressors or chemotherapy drugs

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Conditions

The condition(s) this trial relates to.

celiac disease Iron Deficiencies

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Celiac disease

Contacts and locations

Locations

  • Hôpital Cochin

    Paris, 75014, France

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