NCT05916274Completed
Exploration of the Activity of DNA Located Outside of Cellular Nucleus to Amplify Inflammation in Inflammatory Bowel Disease in Children Through Biological Pathway Cyclic GMP-AMP Synthase (cGAS) - Stimulator of Interferon Genes (STING)
Pro-inflammatory Role of Extracellular DNA in Inflammatory Bowel Disease in Children: Study of the cGAS-STING Pathway
Source: ClinicalTrials.gov · Last updated 23 Dec 2025
Brief summary (registry, in English)
Frequency of Inflammatory Bowel Diseases in children (IBD)-Crohn's disease (CD), Ulcerative colitis (UC) is constantly increasing. Pediatric-onset IBD represent a different nosological entity (from adult IBD) because of their major inflammatory activity, their significant anatomical extent and their stenotic and/or fistulizing character sometimes from diagnosis. Intestinal lesions are due to dysregulation of the intestinal immune system but the cause is unknown. The investigators hypothesize that extranuclear DNA participates in the amplification of the inflammatory response at the intestinal and blood levels during pediatric IBD through the cGAS-STING pathway. The investigators will analyse blood and fecal samples, and colonic biopsies issued from ill children and control participants on age of 6 to 17 years. The investigators think that this study will provide a better understanding of the mechanisms involved in pediatric IBD, assess the place of the cGAS-STING pathway, identify potential biomarkers of pediatric IBD and new potential therapeutic targets based in particular on the inhibition of the cGAS-STING pathway.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 5 May 2023
- Start date
- May 2023
- Primary completion date
- Feb 2024
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Diseases
- Crohn's disease, Ulcerative colitis
- NCT number
- NCT05916274
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From May 2023 to the primary completion date, Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Co-existing severe chronic pathology and/or treatment that could interfere with the results of the study; example: trisomy 21, treatment with growth hormone etc.
Lab values
- Blood hemoglobin level less than or equal to 9 g/dl
Other
- Refusal of the participant and/or one of his two parents
- Body weight less than or equal to 20 kg
- Refusal or contraindication to general anesthesia
- Protected person (under guardianship or curatorship)
- Person under legal protection
- Person not affiliated to a social security scheme
- Pregnant or breastfeeding woman
Who the study is looking for
- Participants aged from 6 years inclusive to 17 years inclusive
- Boys and girls
- Presenting an IBD or suspicion of IBD
- Requiring a colonoscopy for diagnosis or follow-up or other reason (abdominal pain, diarrhoea, rectal bleeding, weight loss) not confirming the diagnosis of Crohn's disease or Ulcerative Colitis
- Active IBD if:
- CD: PCDAI score \>5 and CRP\>20mg/L and faecal calprotectin\> 400 µg/g
- UC: PUCAI score\>10 and faecal calprotectin\>250 µg/g
- IBD in remission if:
- CD: PCDAI score\<5 and CRP\<20mg/L and faecal calprotectin\<400 µg/g
- UC: PUCAI score \<10 and faecal calprotectin \< 250 µg/g
- Patients and their parents who gave their consent to participate in the study
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Orléans Coordinator of this site? Confirm its status | Orléans | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.