NCT04283864Fut, nem toboroz
Decoding Personalized Nutritional, Microbiome and Host Patterns Impacting Clinical and Prognostic Features in Crohn's Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 29.
Rövid összefoglaló (regiszter, angolul)
This is a three-arm, non-interventional observational study designed to investigate the relationship between Crohn's disease (CD), the microbiome, and diet in children.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 267 (tényleges)
- Első benyújtás
- 2019. nov. 19.
- Kezdés
- 2020. nov. 29.
- Elsődleges befejezés
- 2026. dec.
- Fő szponzor
- Weizmann Institute of Science
- Betegségek
- Crohn-betegség
- NCT-szám
- NCT04283864
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 267
- 2020. nov. 29. és az elsődleges befejezés (2026. dec.) között
- 8 helyszín, 7 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalors/creams/ointments should not be excluded from the study.
- Use of systemic antibiotics, probiotics or NSAIDs during 30 days prior to enrollment.
- Gut-related surgery, including bariatric surgery.
- Control group not undergoing colonoscopy:
- Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalors/creams/ointments should not be excluded from the study.
- Use of systemic antibiotics, probiotics or NSAIDs during 30 days prior to enrollment.
- Gut-related surgery, including bariatric surgery.
Más betegség
- Any known autoimmune or rheumatologic disease.
- Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
- Past or present history of malignancy.
- Any known autoimmune or rheumatologic disease.
- Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
- Past or present history of malignancy.
Életkor
- CD study group
- Any known autoimmune or rheumatologic disease.
- Chronic gastro-intestinal disorder (e.g. celiac disease, eosinophilic esophagitis, collagenous gastritis, autoimmune gastritis, etc.).
- Past or present history of malignancy.
- Primary immunodeficiency.
- Pregnancy in the last 6 months, breastfeeding.
- Morbid obesity (BMI > 95th percentile for their age and gender).
- Following particular dietary regimen/dietitian consultation/participation in another study.
- Chronic treatment with any oral/systemic immunosuppressive or anti-inflammatory drugs (e.g. steroids, 5-aminosalicylic acid, immunomodulators, biologics, etc.). Patients receiving these drugs as inhalors/creams/ointments should not be excluded from the study.
- Use of systemic antibiotics, probiotics or NSAIDs during 30 days prior to enrollment.
- Gut-related surgery, including bariatric surgery.
- Inability of the participant and nuclear family to follow and utilize the smartphone application.
- Control group undergoing endoscopy:
- Morbid obesity (BMI > 95th percentile for their age and gender).
- Morbid obesity (BMI > 95th percentile for their age and gender).
Egyéb
- Primary immunodeficiency.
- Pregnancy in the last 6 months, breastfeeding.
- Following particular dietary regimen/dietitian consultation/participation in another study.
- Primary immunodeficiency.
- Pregnancy in the last 6 months, breastfeeding.
- Following particular dietary regimen/dietitian consultation/participation in another study.
Kiket keres a vizsgálat
- CD study group - 'Consent form - Part 1'
- Children with clinical suspicion for CD.
- Between 6 and 18 years of age.
- Naïve to any medical or nutritional intervention.
- CD study group - 'Consent form - Part 2'
- Children with CD confirmed by endoscopy (and based on accepted criteria)
- Between 6 and 18 years of age.
- Naïve to any medical or nutritional intervention.
- Control group undergoing endoscopy children between 6 and 18 years of age undergoing colonoscopy for non-specific abdominal pain or other non-inflammatory gastrointestinal conditions.
- Control group not undergoing colonoscopy
- Children with no symptoms or signs of gastrointestinal disease and no known medical conditions.
- Children between 6 and 18 years of age. These children will be recruited from general pediatric clinics (children attending for routine check-up), orthopedic clinics, ophthalmology clinics or schools.
Életkor a regiszterben: 6 év – 18 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (8)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Alberta | Edmonton | Kanada | Ismeretlen állapot |
| Hospital Sant Joan de Déu | Barcelona | Spanyolország | Ismeretlen állapot |
| Children's Hospital Zagreb | Zagreb | Horvátország | Ismeretlen állapot |
| Schneider Children's Medical Center | Petah Tikva | Izrael | Ismeretlen állapot |
| Dana-Dwek Children's Hospital | Tel Aviv | Izrael | Ismeretlen állapot |
| University of Naples Federico II | Naples | Olaszország | Ismeretlen állapot |
| Amsterdam UMC | Amsterdam | Hollandia | Ismeretlen állapot |
| Sachs' Children and Youth Hospital | Stockholm | Svédország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.