Effects of Omega-3 Fatty Acids on Inflammation and Gut Microbiota in Celiac Disease
A legfontosabb adatok
- Ki végzi
- University of Chile
- Hol
- Santiago (Chile)A helyszín megnézése
- Azonosító
- Állapot
- Toboroz
- Résztvevők
- 40 fő, tervezett
- Kezdés
- 2025. okt. 1.
- Várható befejezés
- 2026. dec. 30.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
- A vizsgált kezelések
- n-3 Polyunsaturated Fatty Acids (PUFAs)
- Placebo
- A regiszteradat frissítve
- 2026. május 14.
Ki vehet részt
- Életkor
- 18 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 2 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
Nézd meg, megfelelhetsz-e
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 65 év között vagy?
Helyszínek itt: Chile
- University of Chile Clinical HospitalSantiago, ChileContact: Paulina Toledo (Clinical Research Coordinator)+569Résztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
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).
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- Omega-3 PUFA SupplementA vizsgált kezelés
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.
Kezelés: n-3 Polyunsaturated Fatty Acids (PUFAs)
- PlaceboPlacebo, összehasonlításként
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.
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Modulation of Blood and Small Intestinal Inflammatory Processes and Fecal Microbiota in Celiac Disease Associated With the Intake of n-3 Polyunsaturated Fatty Acids
- Illeszkedési kérdések
- Forrás: NCT07585669: ki vehet részt
- A regiszteradat frissítve
- 2026. május 14.