Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07585669

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

Led by University of Chile · Updated on 2026-05-14

40

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

Sponsors

U

University of Chile

Lead Sponsor

C

Clínica Universidad de los Andes

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether omega-3 fatty acid supplements can help reduce inflammation and promote healing in adults recently diagnosed with celiac disease. Celiac disease is an autoimmune condition where eating gluten damages the small intestine, causing symptoms like stomach pain and diarrhea. While a gluten-free diet is the current treatment, some patients continue to experience inflammation, so this study aims to see if adding omega-3 supplements can improve recovery. Participants will be randomly assigned to one of two groups: one group will take daily omega-3 supplements containing 2,400 mg of n-3 PUFAs (2,000 mg DHA and 400 mg EPA), while the other group will receive a placebo pill that looks identical. Both groups will follow a supervised gluten-free diet for three months. Throughout this period, clinical symptoms, diet adherence, and safety will be closely monitored, and some participants will have small intestinal biopsies to assess healing. During the study, participants will visit the clinic regularly for checkups, blood tests, and to provide blood and stool samples before and after the intervention. Researchers will analyze inflammation markers in blood cells, study gut bacteria diversity, and assess immune responses and oxidative stress. The main outcome is to measure changes in systemic inflammatory responses, with results helping to understand how omega-3 may influence gut health. Participation is voluntary, with safety monitored throughout, and participants may leave the study at any time without affecting their medical care.

CONDITIONS

Brief Title

Effects of Omega-3 Fatty Acids on Inflammation and Gut Microbiota in Celiac Disease

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Newly diagnosed with celiac disease confirmed by blood tests and intestinal biopsy
  • Not yet started a gluten-free diet
  • Willing to follow a supervised gluten-free diet during the study
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Previous or current adherence to a gluten-free diet
  • Use of omega-3 or other supplements affecting inflammation within the last 3 months
  • Presence of other autoimmune, inflammatory, or gastrointestinal diseases such as Crohn's disease or ulcerative colitis
  • Pregnancy or breastfeeding
  • Severe chronic illnesses like uncontrolled diabetes or cancer
  • Allergy or intolerance to fish oil or supplement components
  • Use of immunosuppressive or anti-inflammatory medications within the last 3 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 months

Participants receive daily oral supplementation with either omega-3 polyunsaturated fatty acids or placebo for 3 months while following a supervised gluten-free diet. Clinical symptoms, dietary adherence, and safety are monitored throughout this period.

Monthly visits during supplementation

Trial Site Locations

Total: 1 location

1

University of Chile Clinical Hospital

Santiago, Metropolitan Region, Chile, 8380000

Actively Recruiting

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Research Team

K

Karla A Bascuñán, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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