Chronic Inflammatory Small Bowel DiseaseMOBIDICNCT06189599
Modified antioxIdants Bacteria for Gut Inflammation
An observational study of Chronic Inflammatory Small Bowel Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Small Bowel Disease
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2024to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: patients suffering from IBD and followed in the gastroenterology and nutrition department of Saint-Antoine hospital
Who may be able to join
- 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
Who cannot join
- patients with cognitive disorders,
- patients who cannot read and understand French
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gastroentérologie en Nutrition - Hôpital St Antoine
Paris, 75012
About this study
Official title: Modified Bacteria for Mn-based antioxIdants Production and Delivery for Gut Inflammation Control
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.
Read more
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.
Read the 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:
- understand the representations of competing therapies for this type of pathologies, i.e. conventional drug treatments, probiotics, TMF and CMB and GMB;
- measure the acceptability of CMB and GMB by the patients themselves;
- 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.
- Conditions
- Chronic Inflammatory Small Bowel Disease
- Keywords
- IBD, Treatment acceptability, well-being
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Quality of life
Short IBDQ questionnaire (e.g. Williet et al., 2017), cognitive dimension of well-being assessed by the life satisfaction scale (e.g. Duboz et al., 2022, scale validated in French).
Measured: 9 months
Factors associated with quality of life and well-being, based on the questionnaire
Quality of life measured by the short IBDQ questionnaire (e.g. Williet et al., 2017), cognitive dimension of well-being assessed by the life satisfaction scale (e.g. Duboz et al., 2022, scale validated in French).
Research into factors associated with quality of life and well-being, based on the questionnaire: bivariate and multivariate analyses.
Measured: 12 months
Differential acceptability of the 4 treatments studied
Comparison of acceptability rates using Chi2 tests. Cross-analyses between health indicators, socio-demographic factors, quality of life and well-being: based on the questionnaires, dedicated statistical analyses (correlations, Student tests, ANOVA, Chi2, regressions, cluster analyses).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion2 Feb 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Small Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Philippe Seksik, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189599
- Sponsor's protocol ID
- APHP231159
- Acronym
- MOBIDIC
- Status last verified
- Dec 2023
- First submitted
- 19 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be collected and analyzed on site
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Bacteria for Mn-based antioxIdants Production and Delivery for Gut Inflammation Control
- ClinicalTrials.gov ID
- NCT06189599
- Acronym / sponsor ID
- MOBIDIC / APHP231159
- Conditions
- Chronic Inflammatory Small Bowel Disease
- Keywords
- IBD, Treatment acceptability, well-being
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 2 Feb 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 3 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- understand the representations of competing therapies for this type of pathologies, i.e. conventional drug treatments, probiotics, TMF and CMB and GMB;
- measure the acceptability of CMB and GMB by the patients themselves;
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients suffering from IBD and followed in the gastroenterology and nutrition department of Saint-Antoine hospital
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- patients with cognitive disorders,
- patients who cannot read and understand French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatments acceptability
Time frame: 6 months
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
3 secondary outcomes
Quality of life
Time frame: 9 months
Factors associated with quality of life and well-being, based on the questionnaire
Time frame: 12 months
Differential acceptability of the 4 treatments studied
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No. Data will be collected and analyzed on site
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Seksik principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Inflammatory Small Bowel Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatments acceptability (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.