Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Omega-3 fats to reduce inflammation in adults with newly diagnosed celiac disease

Official title: Modulation of Blood and Small Intestinal Inflammatory Processes and Fecal Microbiota in Celiac Disease Associated With the Intake of n-3 Polyunsaturated Fatty Acids

Run by University of Chile · NCT07585669 · Data updated 2026-11-12

This study tests whether adding omega-3 fatty acid supplements to a gluten-free plan helps reduce inflammation and promote intestinal healing in adults who have just been diagnosed with celiac disease.

More Celiac Disease trials

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment40 (estimated)
SponsorUniversity of Chile
Academic / other
Locations1 site (Santiago, Metropolitan Region)
StatusRecruiting
StartedOctober 1, 2025
Main results expectedOctober 30, 2026
Study endsDecember 30, 2026
Registry record updatedMay 14, 2026
Trial IDNCT07585669 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 18–65 who have been newly diagnosed with celiac disease, have not started a gluten-free diet, and are willing to adhere to a supervised gluten-free plan.

Probably not a fit

Individuals not experiencing inflammation or intestinal inflammation that responds similarly to diet alone may not see additional benefit from omega-3s.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults 18 to 65 with newly diagnosed celiac disease, who have not yet started a gluten-free diet, will be randomized to receive either 2.4 grams per day of omega-3 fatty acids or a placebo for three months while beginning a supervised gluten-free diet. The trial will measure markers of inflammation in the blood and assess intestinal healing. This is an interventional study conducted alongside standard dietary treatment to see if omega-3s offer additional benefit. The study is led by the University of Chile with collaboration from Clínica Universidad de los Andes and is based at the University of Chile Clinical Hospital in Santiago.

Why it matters

Potential benefit: If successful, omega-3 supplementation could enhance intestinal healing and reduce inflammation beyond diet alone.

How similar studies have gone: Earlier research in other inflammatory conditions suggests omega-3s can modulate inflammation, but results in celiac disease are not yet established.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Adult patients aged 18 to 65 years, Newly diagnosed with celiac disease confirmed by serology and intestinal biopsy, Not yet started gluten-free diet (GFD), Willingness to adhere to a supervised gluten-free diet during the study, Able to provide informed consent

Exclusion Criteria:

* Previous or current adherence to a gluten-free diet, Use of n-3 PUFA supplements or other dietary supplements influencing inflammation within the last 3 months, Presence of other autoimmune, inflammatory, or gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis), Pregnancy or breastfeeding, Severe chronic illnesses that may interfere with the study or outcomes (e.g., uncontrolled diabetes, cancer), Allergy or intolerance to fish oil or components of the supplement, Use of immunosuppressive or anti-inflammatory medication within the last 3 months

Where it's running

  • University of Chile Clinical Hospital
    Santiago, Metropolitan Region, Chile
    Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.