The Microbiome in Uveitis and Pediatric Inflammatory Diseases

NCT07885501 — Not yet recruiting, 500 participants, Assistance Publique - Hôpitaux de Paris

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The Gut Microbiota in Uveitis and Pediatric Inflammatory Diseases: Identification of the Fecal Peptidoglycan Signature

RegistryNCT07885501, acronym MUMIP
StatusNot yet recruiting
Study typeObservational
Enrollment500 (Estimated)
SponsorAssistance Publique - Hôpitaux de Paris (Other)
ConditionsNoninfectious Uveitis
Datesstart 2026-11-01 (estimated), primary completion 2028-11-01 (estimated), completion 2028-12-01 (estimated), first posted 2026-10-21, last updated 2026-10-21
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Noninfectious Uveitis

-Summary

Chronic, noninfectious uveitis in children, associated with various systemic inflammatory diseases, carries a high risk of vision loss. Intestinal dysbiosis and the translocation of bacterial peptidoglycans (PG) that activate innate receptors recognizing PG could represent a common initiating mechanism, independent of the underlying disease. Studying these biological signatures in comparative cohorts could lead to a better understanding of the onset of uveitis and the development of targeted diagnostic and therapeutic strategies.

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+Detailed description

The objectives of this project are to characterize the peptidoglycan (PG) signature in healthy children and in the context of pediatric noninfectious uveitis; to compare the peptidoglycan signatures of patients with noninfectious uveitis to those with pediatric inflammatory diseases without uveitis; and to determine the correlation between these PG signatures, microbiota composition, and disease parameters in the context of uveitis.

Participants will be informed about the study during their routine follow-up visits.

* A stool collection kit, containing all necessary supplies and instructions, will be provided to families.
* Samples will be collected at the hospital or at home and then sent directly to the laboratory by mail.
* For patients, blood samples collected as part of routine care (blood draws for routine laboratory tests) and of which a portion is not used will be collected to establish a biobank dedicated to research.

These procedures do not require any additional medical procedures or visits beyond routine follow-up.

+Arms and interventions

ArmTypeInterventionsDescription
patients with noninfectious uveitisincluding pediatric connective tissue disorders, granulomatosis, idiopathic juvenile arthritis without uveitis, pediatric vasculitis, and chronic inflammatory bowel diseases. These conditions were selected because of their inflammatory and/or autoimmune nature, making it possible to determine whether fecal peptidoglycan signatures
patients with another inflammatory diseasewithout uveitis (connective tissue disease, granulomatosis, juvenile idiopathic arthritis, pediatric vasculitis, chronic inflammatory bowel disease)
healthy children living in the same household as those who are sickSiblings of patients or children of hospital staff, who may be included as healthy control groups

+Outcome measures

Primary outcomes

  • fecal peptidoglycans [Day 1]: the composition and relative abundance of fecal PG fragments in children with uveitis compared to healthy children.

Secondary outcomes

  • Gut Microbiome [Day 1]: * Correlations between the peptidoglycans and the gut microbiota, as determined by sequencing. * Analysis of fecal microRNAs (miRNAs) and their correlations with the peptidoglycans and the microbiota. * Analysis of associations between the peptidoglycans and the microbiota, miRNAs, and clinical parameters: uveitis activity, ophthalmic complications, and patient metadata. * Comparison with the additional control group (non-ocular inflammatory diseases) to identify signatures specific to uveitis versus those associated with a systemic inflammatory condition.

+Eligibility

Sex: All, ages: 1 Day to 17 Years, accepts healthy volunteers

Inclusion Criteria:

* Patients under the age of 18 being treated at Robert-Debré Hospital
* Patients being treated for noninfectious uveitis, or with pediatric inflammatory diseases without uveitis (connective tissue disorders, granulomatosis, juvenile idiopathic arthritis, pediatric vasculitides).
* The child and his or her parents have no objection to participating in the study
* Siblings of patients (family controls) or other healthy controls (children of hospital staff)

Exclusion Criteria:

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+Locations (1)

FacilityCityCountryStatus
Hôpital Robert Debré - APHPParisFrance

+Investigators