Modified antioxIdants Bacteria for Gut Inflammation

NCT06189599 | Unknown

• 1 other identifier: APHP231159
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

IBD; Treatment acceptability; well-being

Outcome Measures

Primary Outcomes (1)

• Treatments acceptability

  It will be a question of determining which treatment(s) is, or are, the most easily accepted by patients with IBD, understanding why patients prefer this or that treatment, but also "how many" of them say they are ready to use them. In other words, the measures will be based on quantitative declarative questionnaires

  6 months

Secondary Outcomes (3)

• Quality of life

  9 months

• Factors associated with quality of life and well-being, based on the questionnaire

  12 months

• Differential acceptability of the 4 treatments studied

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients suffering from IBD and followed in the gastroenterology and nutrition department of Saint-Antoine hospital

You may qualify if:

• Patients with chronic inflammatory bowel diseases.
• Patients over 18 years old.
• Not opposed to participating in the study. - Patients whose diagnosis of IBD was made more than 6 months ago

You may not qualify if:

• patients with cognitive disorders,
• patients who cannot read and understand French

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

Service de Gastroentérologie en Nutrition - Hôpital St Antoine

Paris, 75012, France

Location

Study Officials

• Philippe Seksik

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 3, 2024
• Study Start: February 1, 2024
• Primary Completion: February 2, 2024
• Study Completion: June 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)