Celiac DiseaseOMEGA-CDNCT07585669
Effects of Omega-3 Fatty Acids on Inflammation and Gut Microbiota in Celiac Disease
A study testing n-3 Polyunsaturated Fatty Acids (PUFAs) in people with Celiac Disease, run by University of Chile at 1 site in Chile.
Trial summary
The goal of this clinical trial is to learn if omega-3 fatty acid supplements (n-3 PUFAs) can help reduce inflammation and promote intestinal healing in adults newly diagnosed with celiac disease (CD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Celiac Disease
- What is being tested?
- n-3 Polyunsaturated Fatty Acids (PUFAs)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
University of Chile Clinical Hospital
Santiago, Metropolitan Region, 8380000
Paulina Toledo (Clinical Research Coordinator)+569, 987299944, ptoledo@hcuchi.cl
About this study
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
The goal of this clinical trial is to learn if omega-3 fatty acid supplements (n-3 PUFAs) can help reduce inflammation and promote intestinal healing in adults newly diagnosed with celiac disease (CD).
Celiac disease is a chronic autoimmune disorder where eating gluten-a protein found in wheat-triggers an immune response that damages the lining of the small intestine. This damage causes inflammation and symptoms such as stomach pain, diarrhea, and nutrient absorption problems. The only current treatment is a strict gluten-free diet (GFD), which can help most people recover, but some continue to have inflammation and symptoms.
Read more
This study will test whether supplementing with 2.4 grams of n-3 PUFAs daily for three months, alongside starting a gluten-free diet, reduces inflammation in the blood and intestine more effectively than the gluten-free diet alone.
Participants will:
Be adults recently diagnosed with celiac disease who have not yet started a gluten-free diet
Be randomly assigned to one of two groups:
One group will receive omega-3 supplements containing 2,400 mg of n-3 PUFAs daily (2,000 mg DHA and 400 mg EPA) The other group will receive a placebo (a pill with no active ingredients that looks like the supplement) Take the assigned supplement every day for 3 months while following a supervised gluten-free diet Visit the clinic regularly for checkups, blood tests, and monitoring of symptoms and diet adherence Provide blood and stool samples before and after the intervention to measure inflammation and changes in gut bacteria A subgroup of participants will undergo small intestinal biopsies to assess local inflammation and healing
The study aims to answer these main questions:
Does omega-3 supplementation change the fatty acid composition in blood cells? Does it reduce markers of inflammation in the blood and small intestine? Does it improve the diversity and health of gut bacteria in the intestine? Does it help the small intestine heal faster compared to diet alone?
Researchers will measure inflammation by analyzing immune signaling pathways, oxidative stress markers, and antioxidant activity in blood cells. They will also study the composition of the gut microbiota and its metabolites. These detailed measurements will help understand how omega-3 fatty acids may influence the immune response and gut health in celiac disease.
This is a randomized, double-blind, placebo-controlled crossover study. This means participants and researchers will not know who receives the supplement or placebo during the study period, reducing bias and improving the reliability of the results.
This study is important because it could offer a simple, additional treatment to improve recovery in celiac disease beyond the gluten-free diet. If omega-3 supplements are shown to reduce inflammation and support healing, they could become a valuable part of managing this chronic condition.
Participation is voluntary, and participants can leave the study at any time without affecting their medical care. All participants will be closely monitored to ensure safety throughout the study.
- Conditions
- Celiac Disease
- Being tested
- n-3 Polyunsaturated Fatty Acids (PUFAs), Placebo
- Keywords
- Celiac Disease, Intestinal Inflammation, Omega-3 Fatty Acids
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 Polyunsaturated Fatty Acids (PUFAs)Dietary supplement
Also called Omega-3 fatty acids, DHA + EPA
n-3 PUFAs supplementation consisting of 2,400 mg per day (2,000 mg docosahexaenoic acid [DHA] and 400 mg eicosapentaenoic acid [EPA]), administered orally for 3 months in newly diagnosed adult celiac disease patients. The supplementation is given alongside the initiation of a gluten-free diet (GFD). The aim is to assess whether supplementation modulates the inflammatory response and supports intestinal recovery. This is part of a randomized, double-blind, placebo-controlled, crossover trial comparing supplementation versus placebo.
PlaceboDietary supplement
Also called Placebo supplement, Placebo capsule
Placebo capsules identical in appearance and taste to the active n-3 polyunsaturated fatty acid (PUFA) supplement, administered orally once daily for 3 months in newly diagnosed adult celiac disease patients. Participants will simultaneously begin a supervised gluten-free diet. This intervention serves as a control to evaluate the effect of the active supplement on modulating the inflammatory response and intestinal recovery.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 PUFA Supplement | Experimental | Participants in this group will receive daily oral supplementation with 2,400 mg of omega-3 polyunsaturated fatty acids (2,000 mg DHA and 400 mg EPA) for 3 months. All participants will start a supervised gluten-free diet at the same time. Clinical symptoms, dietary adherence, and safety will be monitored throughout the intervention period. Receives: Dietary Supplement: n-3 Polyunsaturated Fatty Acids (PUFAs) |
| Placebo | Placebo comparator | Participants in this group will receive a daily oral placebo supplement, identical in appearance and taste to the omega-3 supplement, for 3 months. All participants will begin a supervised gluten-free diet at the same time. Clinical symptoms, dietary adherence, and safety will be monitored throughout the intervention period. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of systemic inflammatory response via cytokine levels and NF-κB signaling in peripheral blood mononuclear cells
Levels of proinflammatory cytokines and NF-κB signaling in peripheral blood mononuclear cells will be measured to assess the reduction of systemic inflammation in newly diagnosed adult celiac patients receiving n-3 PUFA supplementation versus placebo.
Measured: From baseline (T0) to 3 months (T3) of supplementation
Secondary outcomes (1)
Changes in fatty acid composition of erythrocyte and peripheral blood mononuclear cell membranes
The fatty acid profiles of erythrocyte and peripheral blood mononuclear cell membranes will be analyzed at baseline and after 3 months to assess the impact of n-3 PUFA supplementation on membrane lipid composition in adult celiac disease patients.
Measured: From baseline (T0) to 3 months (T3) of supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Oct 2025
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Clínica Universidad de los Andes
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585669
- Sponsor's protocol ID
- 11240685
- Acronym
- OMEGA-CD
- Status last verified
- Nov 2025
- First submitted
- 6 May 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) collected during this study will be made available to qualified researchers upon reasonable request after publication of the primary study results. Data sharing requests will be reviewed by the study steering committee to ensure appropriate use and compliance with ethical and privacy regulations. Data will be shared through a secure data repository, and a data use agreement will be required.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07585669
- Acronym / sponsor ID
- OMEGA-CD / 11240685
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, Intestinal Inflammation, Omega-3 Fatty Acids
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ChileUniversity, hospital or other
- Collaborators
- Clínica Universidad de los Andes
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if omega-3 fatty acid supplements (n-3 PUFAs) can help reduce inflammation and promote intestinal healing in adults newly diagnosed with celiac disease (CD).
Celiac disease is a chronic autoimmune disorder where eating gluten-a protein found in wheat-triggers an immune response that damages the lining of the small intestine. This damage causes inflammation and symptoms such as stomach pain, diarrhea, and nutrient absorption problems. The only current treatment is a strict gluten-free diet (GFD), which can help most people recover, but some continue to have inflammation and symptoms.
This study will test whether supplementing with 2.4 grams of n-3 PUFAs daily for three months, alongside starting a gluten-free diet, reduces inflammation in the blood and intestine more effectively than the gluten-free diet alone.
Participants will:
Be adults recently diagnosed with celiac disease who have not yet started a gluten-free diet
Be randomly assigned to one of two groups:
One group will receive omega-3 supplements containing 2,400 mg of n-3 PUFAs daily (2,000 mg DHA and 400 mg EPA) The other group will receive a placebo (a pill with no active ingredients that looks like the supplement) Take the assigned supplement every day for 3 months while following a supervised gluten-free diet Visit the clinic regularly for checkups, blood tests, and monitoring of symptoms and diet adherence Provide blood and stool samples before and after the intervention to measure inflammation and changes in gut bacteria A subgroup of participants will undergo small intestinal biopsies to assess local inflammation and healing
The study aims to answer these main questions:
Does omega-3 supplementation change the fatty acid composition in blood cells? Does it reduce markers of inflammation in the blood and small intestine? Does it improve the diversity and health of gut bacteria in the intestine? Does it help the small intestine heal faster compared to diet alone?
Researchers will measure inflammation by analyzing immune signaling pathways, oxidative stress markers, and antioxidant activity in blood cells. They will also study the composition of the gut microbiota and its metabolites. These detailed measurements will help understand how omega-3 fatty acids may influence the immune response and gut health in celiac disease.
This is a randomized, double-blind, placebo-controlled crossover study. This means participants and researchers will not know who receives the supplement or placebo during the study period, reducing bias and improving the reliability of the results.
This study is important because it could offer a simple, additional treatment to improve recovery in celiac disease beyond the gluten-free diet. If omega-3 supplements are shown to reduce inflammation and support healing, they could become a valuable part of managing this chronic condition.
Participation is voluntary, and participants can leave the study at any time without affecting their medical care. All participants will be closely monitored to ensure safety throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega-3 PUFA Supplement | Experimental | Dietary Supplement: n-3 Polyunsaturated Fatty Acids (PUFAs)Participants in this group will receive daily oral supplementation with 2,400 mg of omega-3 polyunsaturated fatty acids (2,000 mg DHA and 400 mg EPA) for 3 months. All participants will start a supervised gluten-free diet at the same time. Clinical symptoms, dietary adherence, and safety will be monitored throughout the intervention period. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants in this group will receive a daily oral placebo supplement, identical in appearance and taste to the omega-3 supplement, for 3 months. All participants will begin a supervised gluten-free diet at the same time. Clinical symptoms, dietary adherence, and safety will be monitored throughout the intervention period. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| n-3 Polyunsaturated Fatty Acids (PUFAs)Also: Omega-3 fatty acids, DHA + EPAn-3 PUFAs supplementation consisting of 2,400 mg per day (2,000 mg docosahexaenoic acid [DHA] and 400 mg eicosapentaenoic acid [EPA]), administered orally for 3 months in newly diagnosed adult celiac disease patients. The supplementation is given alongside the initiation of a gluten-free diet (GFD). The aim is to assess whether supplementation modulates the inflammatory response and supports intestinal recovery. This is part of a randomized, double-blind, placebo-controlled, crossover trial comparing supplementation versus placebo. | Dietary supplement | Omega-3 PUFA Supplement |
| PlaceboAlso: Placebo supplement, Placebo capsulePlacebo capsules identical in appearance and taste to the active n-3 polyunsaturated fatty acid (PUFA) supplement, administered orally once daily for 3 months in newly diagnosed adult celiac disease patients. Participants will simultaneously begin a supervised gluten-free diet. This intervention serves as a control to evaluate the effect of the active supplement on modulating the inflammatory response and intestinal recovery. | Dietary supplement | Placebo |
Primary outcome
Modulation of systemic inflammatory response via cytokine levels and NF-κB signaling in peripheral blood mononuclear cells
Time frame: From baseline (T0) to 3 months (T3) of supplementation
Levels of proinflammatory cytokines and NF-κB signaling in peripheral blood mononuclear cells will be measured to assess the reduction of systemic inflammation in newly diagnosed adult celiac patients receiving n-3 PUFA supplementation versus placebo.
1 secondary outcome
Changes in fatty acid composition of erythrocyte and peripheral blood mononuclear cell membranes
Time frame: From baseline (T0) to 3 months (T3) of supplementation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) collected during this study will be made available to qualified researchers upon reasonable request after publication of the primary study results. Data sharing requests will be reviewed by the study steering committee to ensure appropriate use and compliance with ethical and privacy regulations. Data will be shared through a secure data repository, and a data use agreement will be required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3 Polyunsaturated Fatty Acids (PUFAs) in people with Celiac Disease, run by University of Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karla A Bascuñán, PhD (+56 2 9773232, kbascunan@uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modulation of systemic inflammatory response via cytokine levels and NF-κB signaling in peripheral blood mononuclear cells (time frame: From baseline (T0) to 3 months (T3) of supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.