Status:

NOT_YET_RECRUITING

Association Between the Occurrence of a Clinical RElapse and Gut MIcrobiota Modifications: a Cohort Study of Patients With pSOriasis

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Conditions:

Psoriasis

Microbial Colonization

Eligibility:

All Genders

18+ years

Brief Summary

The human microbiota corresponds to an extremely rich and varied set of microorganisms that colonize our various epitheliums from birth, including the intestine, lungs and skin, where they interact co...

Eligibility Criteria

Inclusion

  • Subject over 18 years of age
  • Subject diagnosed with psoriasis considered in remission (as defined by absolute PASI\<2 within 6 months of follow-up)
  • Subject who has stopped his biologic agent including IL-17 inhibitors or IL-23 inhibitors for 2 to 4 weeks.
  • Written informed consent for participation in the study

Exclusion

  • Subject currently experiencing or having a history of other concomitant skin conditions that would interfere with evaluation of psoriasis
  • Subject treated by NSAIDs, antibiotics, antifungals, antivirals or proton-pump inhibitors within 4 weeks before inclusion (or foreseeable use during the study)
  • Subject with a concomitant diagnosis of cirrhosis, coeliac disease or signs of bacterial infection
  • Subject has concurrent acute or chronic viral hepatitis B or C or human immunodeficiency virus (HIV) infection
  • Subject having a personal or familial history of psoriatic arthritis or inflammatory bowel disease
  • Subject with BMI\<18.5 or BMI\>35
  • Subject consuming probiotics or using specific diet with many dietary exclusions according to the discretion of the investigator
  • Pregnant and /or breastfeeding woman,
  • Subject deprived of liberty by judicial or administrative decision or patient under guardianship
  • Subject unable to understand the purpose and conditions of the study and unable to give consent

Key Trial Info

Start Date :

March 1 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

March 1 2028

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06055699

Start Date

March 1 2024

End Date

March 1 2028

Last Update

September 28 2023

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