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Modified antioxIdants Bacteria for Gut Inflammation

NCT06189599 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-01-03

No results posted yet for this study

Summary

Patients with IBD experience complex therapeutic pathways. The development of new treatments, more effective and free of side effects, is a therapeutic need. However, such therapeutic innovations can only be effective if they are accepted by the target populations.

The objective of this study is to analyze, in patients with chronic inflammatory bowel diseases, the acceptability of 4 different treatments: chemically modified bacteria treatment, genetically modified bacteria treatment, probiotics, and fecal microbiota transplantation.

The acceptability of the treatments, i.e. the patients' responses and their rationalizations, will constitute the evaluation criterion and the result of the research.

This study will also allow us to evaluate the impact of IBD on quality of life and well-being. Research factors associated with quality of life and well-being, based on dedicated questions (scales validated and included in the questionnaire), evaluate the differential acceptability of the 4 treatments studied. Finally, cross-analyses between health, socio-demographic factors, quality of life and well-being will be performed.

Conditions

  • Chronic Inflammatory Small Bowel Disease

Sponsors & Collaborators

  • Centre National de la Recherche Scientifique, France

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Philippe Seksik · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2024-02-02
Completion
2024-06-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06189599 on ClinicalTrials.gov