Clinical trial

Pro-inflammatory Role of Extracellular DNA in Inflammatory Bowel Disease in Children: Study of the cGAS-STING Pathway

Name
CHRO-2023-01
Description
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.
Trial arms
Trial start
2023-05-31
Estimated PCD
2026-06-01
Trial end
2026-06-01
Status
Recruiting
Treatment
Blood and fecal samples
Blood and fecal samples will be performed
Arms:
Patients with samples
Coolonic biopsies
colonic biopsies will be analysed
Arms:
Patients with samples
Size
40
Primary endpoint
Amount of mRNA specific for colonic cGAS
Baseline
Eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Refusal of the participant and/or one of his two parents * Body weight less than or equal to 20 kg * Blood hemoglobin level less than or equal to 9 g/dl * Refusal or contraindication to general anesthesia * 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. * Protected person (under guardianship or curatorship) * Person under legal protection * Person not affiliated to a social security scheme * Pregnant or breastfeeding woman
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2023-06-23

1 organization

1 product

3 indications

Indication
Crohn's Disease