Clinical trial NCT06189599: Modified antioxIdants Bacteria for Gut Inflammation
Official title: Modified Bacteria for Mn-based antioxIdants Production and Delivery for Gut Inflammation Control
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Inflammatory Small Bowel Disease
Keywords: IBD
Treatment acceptability
well-being
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Centre National de la Recherche Scientifique, France
First posted: 2024-01-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients suffering from IBD and followed in the gastroenterology and nutrition department of Saint-Antoine hospital

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.

Detailed description: Patients with IBD experience complex treatment pathways. Therapeutic innovations are necessary but can only be effective if they are accepted by the target populations.

It is therefore a question of understanding and measuring the acceptability of innovative treatments for IBD. Through an analysis carried out by the patients regularly followed for a IBD in day hospital will answer questionnaires, to allow us to:

1. understand the representations of competing therapies for this type of pathologies, i.e. conventional drug treatments, probiotics, TMF and CMB and GMB;
2. measure the acceptability of CMB and GMB by the patients themselves;
3. understand the links between the acceptability of treatments and the health status / socio-economic characteristics of patients.

The main criterion for the acceptability of treatments involving bacteria will be the answers to questions relating to this question.

It will be a question of determining which treatment(s) is, or are, the most easily accepted by patients with IBD, understood as a population, 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 declarative quantitative questionnaires.

There will be only one interview with each patient, lasting between 15 and 20 minutes.

Recruitment will take place in the gastroenterology and nutrition department of Saint-Antoine Hospital (Paris) and more specifically among patients followed in day hospital and in consultation. This tertiary center has an active queue of 3,300 patients and therefore has the single-center capacity to allow the inclusion of 500 patients for a questionnaire study.

The information notice and the non-objection form will be delivered and collected on the day of the investigation. Once the non-objection has been collected, the questionnaire will be distributed to the patient and then collected before leaving the day hospital.

The collection sheets will be collected in a medical office of the service then entered over time in the dedicated e-CRF (Redcap), before the analysis phase.

The data will be analyzed once the computer entry has been completed in full. The analysis will be done on site by ANR MoBIDIC partners under the supervision of the PI, Philippe SEKSIK. No data or data analysis will be done outside of APHP.

Statistical analyzes will include bivariate and multivariate, parametric and non-parametric analyses. For the latter, binary logistic regressions will be of major use because they will make it possible to determine the factors influencing the acceptability (or rejection) of the treatments studied, taking into account the influence of all these factors.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Treatments acceptability
timeFrame: 6 months
Secondary outcomes:
measure: Quality of life
timeFrame: 9 months
measure: Factors associated with quality of life and well-being, based on the questionnaire
timeFrame: 12 months
measure: Differential acceptability of the 4 treatments studied
timeFrame: 12 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Gastroentérologie en Nutrition - Hôpital St Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Seksik
role: PRINCIPAL_INVESTIGATOR
References: