Inflammatory Bowel DiseasesBiomHostNCT05704413
Digestive Biobank for Exploring Microbiota-host Interactions
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jun 2021to 17 Sep 2026
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years-old. With an Ulcerative colitis, Crohn's Disease or colorectal cancer Operated in the Departement of digestive surgery of Saint-Antoine Hospital After signature of the information consent
Who may be able to join
- Ulcerative colitis, Crohn's disease or colorectal disease
- Digestive resection with useless tissue available
- Information consent signed
Who cannot join
- Patients < 18 years
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Viscérale - Hôpital Saint Antoine
Paris, 75012
Jérémie LEFEVRE, PU-PH, +33 (0)1 49 28 25 63, jeremie.lefevre@aphp.fr
Harry SOKOL, PU-PH, +33 (0)1 49 28 25 63, harry.sokol@aphp.fr
About this study
Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.
Read the detailed description
Inflammatory Bowel disease (Crohn, Ulcerative colitis) and colorectal cancer are frequent affections and the microbiota plays a major role in their physiopathology involving the immune system. In this setting, the interplay between gut microbiota and brain is still unexplored.
To evaluate the interaction of the microbiota and the immune system with the host in these two chronic diseases, we aim to create a prospective biobank.
A small amount of tissue will be taken during surgery. A whole blood, plasma and stoll samples will also be taken from the patient.
All samples will be anonymized.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Colorectal Cancer, Indeterminate Colitis
- Keywords
- Microbiota, inflammatory bowel disease, Crohn's disease, ulcerative colitis, colorectal cancer, post-operative cognitive disorders, mood disorders, immune system.
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Colorectal Neoplasms, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| digestive cancer or IBD | Patient with digestive cancer or IBD having surgery with intestinal resection planned in the Visceral Surgery Department of St Antoine Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
identify relations between serumon response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.
Measured: up to 12 months after the incusion
Secondary outcomes (7)
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
identify relations between plasma on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.
Measured: up to 12 months after the incusion
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
identify relations between DNA on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.
Measured: up to 12 months after the incusion
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
identify relations between faeces) on response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.
Measured: up to 12 months after the incusion
Exploratory study on the physiopathology of host-microbiota interactions to determinate the occurrence of intestinal and extra-intestinal complications
genetic polymorphisms, serum markers, intestinal microbiota markers to determining the occurrence of intestinal and extra-intestinal complications
Measured: up to two months after the incusion
Exploratory study on the physiopathology of host-microbiota interactions to determinate the response to treatments
genetic polymorphisms, serum markers, intestinal microbiota markers determining : response to treatments
Measured: up to two months after the incusion
Exploratory study on the physiopathology of host-microbiota interactions
genetic polymorphisms, serum markers, intestinal microbiota markers determining : interactions between host and microbiota
Measured: up to two months after the incusion
Brain-microbiota interaction
Exploring the pathophysiology of host-microbiota interactions in postoperative cognitive or behavioral changes involving inflammation pathways
Measured: up to two months after the incusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start17 Jun 2021
- Primary completion17 Sep 2026 (estimated)
- Study completion17 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérémie LEFEVRE, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704413
- Sponsor's protocol ID
- APHP180540
- Acronym
- BiomHost
- Status last verified
- Jan 2023
- First submitted
- 18 Feb 2019
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digestive Biobank for Exploring Microbiota-host Interactions
- ClinicalTrials.gov ID
- NCT05704413
- Acronym / sponsor ID
- BiomHost / APHP180540
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Colorectal Cancer, Indeterminate Colitis
- Keywords
- Microbiota, inflammatory bowel disease, Crohn's disease, ulcerative colitis, colorectal cancer, post-operative cognitive disorders, mood disorders, immune system.
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 17 Sep 2026 (estimated)
- Study completion
- 17 Sep 2026 (estimated)
- First posted
- 30 Jan 2023 (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.
Constitution of a biobank of tissues, whole blood and plasma samples and stools to identify markers associated with treatment response, postoperative morbidity including neuro-cognitive and mood complications and prognosis of Inflammatory Bowel disease or colorectal cancer.
Detailed description
Inflammatory Bowel disease (Crohn, Ulcerative colitis) and colorectal cancer are frequent affections and the microbiota plays a major role in their physiopathology involving the immune system. In this setting, the interplay between gut microbiota and brain is still unexplored.
To evaluate the interaction of the microbiota and the immune system with the host in these two chronic diseases, we aim to create a prospective biobank.
A small amount of tissue will be taken during surgery. A whole blood, plasma and stoll samples will also be taken from the patient.
All samples will be anonymized.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| digestive cancer or IBD | – | –Patient with digestive cancer or IBD having surgery with intestinal resection planned in the Visceral Surgery Department of St Antoine Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years-old. With an Ulcerative colitis, Crohn's Disease or colorectal cancer Operated in the Departement of digestive surgery of Saint-Antoine Hospital After signature of the information consent
Key inclusion criteria (3 listed)
- Ulcerative colitis, Crohn's disease or colorectal disease
- Digestive resection with useless tissue available
- Information consent signed
Key exclusion criteria (1 listed)
- Patients < 18 years
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
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
Time frame: up to 12 months after the incusion
identify relations between serumon response to treatment, postoperative outcomes including neuro-cognitive and mood complications and prognosis.
7 secondary outcomes
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
Time frame: up to 12 months after the incusion
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
Time frame: up to 12 months after the incusion
Relation between biological parameters and outcomes of digestive disease (IBD, CRC)
Time frame: up to 12 months after the incusion
Exploratory study on the physiopathology of host-microbiota interactions to determinate the occurrence of intestinal and extra-intestinal complications
Time frame: up to two months after the incusion
Exploratory study on the physiopathology of host-microbiota interactions to determinate the response to treatments
Time frame: up to two months after the incusion
Exploratory study on the physiopathology of host-microbiota interactions
Time frame: up to two months after the incusion
Brain-microbiota interaction
Time frame: up to two months after the incusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Inflammatory Bowel Diseases
Not yet recruitingObservational study
Longitudinal Registry of Difficult-to-Treat Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), Crohn Disease
Recruiting
Multi-omics Dissection of Gut Microbiome Engraftment During FMT
Recurrent C. Difficile (rCDI), Ulcerative Colitis (UC)
RecruitingPhase 4
Open-label Single-arm Study to Assess the Efficacy of Mirikizumab in Patients With Inflammatory Strictures Due to CD
Crohn Disease
Not yet recruiting
Online Pain Education for Crohn's Disease and Ulcerative Colitis
Crohn's Disease, Ulcerative Colitis (UC)
RecruitingObservational study
Immune Regulation in Ulcerative Colitis or Crohn s Disease
Inflammatory Bowel Disease, Ulcerative Colitis
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.
Jérémie LEFEVRE, PU-PH 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 Inflammatory Bowel Diseases and Crohn 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 1 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 30 Jan 2023. 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?
Contact Jérémie LEFEVRE, PU-PH (+33 (0)1 49 28 25 63, jeremie.lefevre@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between biological parameters and outcomes of digestive disease (IBD, CRC) (time frame: up to 12 months after the incusion). 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 30 Jan 2023.