IBDNCT06042582
From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD
An observational study of IBD, run by IRCCS San Raffaele.
Trial summary
This study is part of the project funded by the Horizon2020 program for establishing the consortium Algae4IBD (https://algae4ibd.eu/), where OSR participates as a partner. It aims to promote the implementation of the European Crohn's and Colitis Organization (ECCO/FECCO) Directive and the benefit of the Inflammatory… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- IBD
- What is being tested?
- Additional biopsies collection
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 May 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: We will recruit adult patients with CD or UC and without CD and UC, ≥18 and <60 years and without any previously documented gastrointestinal infections in collaboration with the Gastroenterology and Digestive Endoscopy unit (IRCSS Ospedale San Raffaele). CD and UC diagnosis will be determined by clinical and endoscopic scores (described below in inclusion criteria). Control data will come from the same intestinal areas of age-matched no-UC/CD subjects undergoing endoscopic surveillance for not IBD-related conditions (described into the inclusion criteria) according to the standard of care. The participation is voluntary and the patient is allowed to refuse further participation in the protocol whenever he/she wants.
Who may be able to join
- SUBJECTS WITH THE DIAGNOSIS OF UC OR CD:
- subjects undergoing endoscopy and biopsies collection per standard of care
- adult patients ≥18 and <60 years
- Additionally, for people with UC:
- clinical and endoscopic evaluation (Mayo score≥2)
- Additionally, for individuals with CD:
Show all 10Show fewer
- clinical and endoscopic evaluation (Harvey-Bradshaw score ≥5 and overall simplified endoscopic score (SES-CD) >2)
- SUBJECTS NOT AFFECTED BY UC OR CD:
- subjects undergoing endoscopy and biopsies collection (≥18 and <60 years) according to the normal clinical practice (as patients undergoing cancer surveillance, irritable bowel syndrome (IBS), diarrhea)
- subjects not affected by UC or CD according to the previously reported clinical and endoscopic evaluation criteria All patients will sign the informed consent.
Who cannot join
- SUBJECTS WITH THE DIAGNOSIS OF UC OR CD:
- subjects with UC or CD who do not have the previously described clinical and endoscopic evaluation criteria
- SUBJECTS NOT AFFECTED BY UC OR CD (CONTROL GROUP):
- -subjects undergoing anti-inflammatory and/or immunosuppressive treatments for other diseases not related to UC or CD
About this study
This study is part of the project funded by the Horizon2020 program for establishing the consortium Algae4IBD (https://algae4ibd.eu/), where OSR participates as a partner. It aims to promote the implementation of the European Crohn's and Colitis Organization (ECCO/FECCO) Directive and the benefit of the Inflammatory Bowel Disease (IBD) patient's wellness by finding innovative algae based novel small molecule therapeutics. A systemic approach to eco-innovation is adopted to create interconnections between sectors, value chains, natural resources, and relevant societal stewards. To this end, the consortium has set specific objectives to achieve holistic innovations, including technical, economic, health, and social factors that all work in concert.
IBD included Crohn's disease and ulcerative colitis. It is a class of chronic inflammatory disorders with complex pathogenesis. Despite the lack of a full understanding of its etiogenesis, many anti-inflammatory treatments have been developed over the last decades. However, not all patients may benefit from these treatments and some of them are refractory to the current therapies or experience relapse of the disease. Therefore, there is still an urgent need to find an innovative line of interventions for ameliorating these patients' overall quality of life.
Algae4IBD consortium will form a bridge between innovation and market demands to prevent and treat inflammation, pain, and IBD. Bioactive molecule/compounds extracts from microalgae, cyanobacteria, and macro-algae (MiaCyMa) are an inexhaustible untapped natural source for products destined for IBD prevention and treatment (inflammation, pain, and the disease process associated with the gut's microbiome). The natural source potential is still more promising when considering extremophile strains for excellent metabolism systems. Moreover, the production of the natural source of biological materials should be sustainable. Indeed, the non-genetically modified organisms (GMO cultures offer numerous advantages such as reduced requirements of fresh water and land (no arable land is required), drastic reduction of nitrogen sources, and potential environmental threats. Algae4IBD concept will include a multi-step screening approach and feedback loops across the project steps to achieve its goals. Specifically, OSR is in charge with work package (WP) 4, task 4.4, which aims to characterize the activity of plant cell (algae) extracts named in this proposal as "natural compounds" of algae provided by the consortium in ex-vivo models, using bioptic samples derived from patients with IBD (patients with ulcerative colitis (UC) and Crohn's disease (CD)), comparing them to samples derived from patients without UC and CD.
- Conditions
- IBD
- Being tested
- Additional biopsies collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional biopsies collectionProcedure or surgery
We will recruit only subjects (UC, CD and NO-UC/CD) scheduled for the endoscopy and biopsies-collection according to the usual clinical practice. During the endoscopy we will collect 6 additional biopsies.
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis (UC) | * subjects undergoing endoscopy and biopsies collection per standard of care
* adult patients ≥18 and <60 years
* clinical and endoscopic evaluation (Mayo score≥2) Receives: Procedure: Additional biopsies collection | |
| Crohn's Disease (CD) | * subjects undergoing endoscopy and biopsies collection per standard of care
* adult patients ≥18 and <60 years
* clinical and endoscopic evaluation (Harvey-Bradshaw score ≥5 and overall simplified endoscopic score (SES-CD) >2) Receives: Procedure: Additional biopsies collection | |
| NO UC/CD | * subjects undergoing endoscopy and biopsies collection (≥18 and <60 years) according to the normal clinical practice (as patients undergoing cancer surveillance, irritable bowel syndrome (IBS), diarrhea)
* subjects not affected by UC or CD according to the previously reported clinical and endoscopic evaluation criteria Receives: Procedure: Additional biopsies collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the response of intestinal mucosa samples to treatments with natural compounds derived from algae in terms of release of pro-inflammatory factors (1), transcriptomics, metatranscriptomics (2) and lipidomics analysis (3)
- Release of pro-inflammatory cytokines using ELISA
- RNA-Seq-generated FASTQ reads from human colons will be quality filtered and adaptor trimmed with NCBI fastq-dump.
- Lipids detected by LC-MS/MS will be classified based on their precursors, and, in parallel, based on their metabolic pathways.
By multi-omic factor analysis we will integrate these data with the patients' clinical parameters, correlating among each other in parallel and giving one single output (outcome measure, in our case, multiomic factor) explaining how the different omic layers are assigned simultaneously to specific clinical characteristics, thus resulting as associated with, or predictive of, the clinical progression of IBD.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvio Danese, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042582
- Sponsor's protocol ID
- Algae4IBD
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 18 Sep 2023
- Results posted
- 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 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD
- ClinicalTrials.gov ID
- NCT06042582
- Acronym / sponsor ID
- Algae4IBD
- Conditions
- IBD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 18 Sep 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.
This study is part of the project funded by the Horizon2020 program for establishing the consortium Algae4IBD (https://algae4ibd.eu/), where OSR participates as a partner. It aims to promote the implementation of the European Crohn's and Colitis Organization (ECCO/FECCO) Directive and the benefit of the Inflammatory Bowel Disease (IBD) patient's wellness by finding innovative algae based novel small molecule therapeutics. A systemic approach to eco-innovation is adopted to create interconnections between sectors, value chains, natural resources, and relevant societal stewards. To this end, the consortium has set specific objectives to achieve holistic innovations, including technical, economic, health, and social factors that all work in concert.
IBD included Crohn's disease and ulcerative colitis. It is a class of chronic inflammatory disorders with complex pathogenesis. Despite the lack of a full understanding of its etiogenesis, many anti-inflammatory treatments have been developed over the last decades. However, not all patients may benefit from these treatments and some of them are refractory to the current therapies or experience relapse of the disease. Therefore, there is still an urgent need to find an innovative line of interventions for ameliorating these patients' overall quality of life.
Algae4IBD consortium will form a bridge between innovation and market demands to prevent and treat inflammation, pain, and IBD. Bioactive molecule/compounds extracts from microalgae, cyanobacteria, and macro-algae (MiaCyMa) are an inexhaustible untapped natural source for products destined for IBD prevention and treatment (inflammation, pain, and the disease process associated with the gut's microbiome). The natural source potential is still more promising when considering extremophile strains for excellent metabolism systems. Moreover, the production of the natural source of biological materials should be sustainable. Indeed, the non-genetically modified organisms (GMO cultures offer numerous advantages such as reduced requirements of fresh water and land (no arable land is required), drastic reduction of nitrogen sources, and potential environmental threats. Algae4IBD concept will include a multi-step screening approach and feedback loops across the project steps to achieve its goals. Specifically, OSR is in charge with work package (WP) 4, task 4.4, which aims to characterize the activity of plant cell (algae) extracts named in this proposal as "natural compounds" of algae provided by the consortium in ex-vivo models, using bioptic samples derived from patients with IBD (patients with ulcerative colitis (UC) and Crohn's disease (CD)), comparing them to samples derived from patients without UC and CD.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis (UC) | – | Procedure: Additional biopsies collection* subjects undergoing endoscopy and biopsies collection per standard of care * adult patients ≥18 and <60 years * clinical and endoscopic evaluation (Mayo score≥2) |
| Crohn's Disease (CD) | – | Procedure: Additional biopsies collection* subjects undergoing endoscopy and biopsies collection per standard of care * adult patients ≥18 and <60 years * clinical and endoscopic evaluation (Harvey-Bradshaw score ≥5 and overall simplified endoscopic score (SES-CD) >2) |
| NO UC/CD | – | Procedure: Additional biopsies collection* subjects undergoing endoscopy and biopsies collection (≥18 and <60 years) according to the normal clinical practice (as patients undergoing cancer surveillance, irritable bowel syndrome (IBS), diarrhea) * subjects not affected by UC or CD according to the previously reported clinical and endoscopic evaluation criteria |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We will recruit adult patients with CD or UC and without CD and UC, ≥18 and <60 years and without any previously documented gastrointestinal infections in collaboration with the Gastroenterology and Digestive Endoscopy unit (IRCSS Ospedale San Raffaele). CD and UC diagnosis will be determined by clinical and endoscopic scores (described below in inclusion criteria). Control data will come from the same intestinal areas of age-matched no-UC/CD subjects undergoing endoscopic surveillance for not IBD-related conditions (described into the inclusion criteria) according to the standard of care. The participation is voluntary and the patient is allowed to refuse further participation in the protocol whenever he/she wants.
Key inclusion criteria (10 listed)
- subjects undergoing endoscopy and biopsies collection per standard of care
- adult patients ≥18 and <60 years
- clinical and endoscopic evaluation (Mayo score≥2)
- clinical and endoscopic evaluation (Harvey-Bradshaw score ≥5 and overall simplified endoscopic score (SES-CD) >2)
- subjects undergoing endoscopy and biopsies collection (≥18 and <60 years) according to the normal clinical practice (as patients undergoing cancer surveillance, irritable bowel syndrome (IBS), diarrhea)
Key exclusion criteria (4 listed)
- subjects with UC or CD who do not have the previously described clinical and endoscopic evaluation criteria
- -subjects undergoing anti-inflammatory and/or immunosuppressive treatments for other diseases not related to UC or CD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional biopsies collectionWe will recruit only subjects (UC, CD and NO-UC/CD) scheduled for the endoscopy and biopsies-collection according to the usual clinical practice. During the endoscopy we will collect 6 additional biopsies. | Procedure or surgery | Crohn's Disease (CD), NO UC/CD, Ulcerative Colitis (UC) |
Primary outcome
To evaluate the response of intestinal mucosa samples to treatments with natural compounds derived from algae in terms of release of pro-inflammatory factors (1), transcriptomics, metatranscriptomics (2) and lipidomics analysis (3)
Time frame: 30 months
1. Release of pro-inflammatory cytokines using ELISA 2. RNA-Seq-generated FASTQ reads from human colons will be quality filtered and adaptor trimmed with NCBI fastq-dump. 3. Lipids detected by LC-MS/MS will be classified based on their precursors, and, in parallel, based on their metabolic pathways. By multi-omic factor analysis we will integrate these data with the patients' clinical parameters, correlating among each other in parallel and giving one single output (outcome measure, in our case, multiomic factor) explaining how the different omic layers are assigned simultaneously to specific clinical characteristics, thus resulting as associated with, or predictive of, the clinical progression of IBD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of IBD, run by IRCCS San Raffaele.
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 10 inclusion and 4 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 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
To evaluate the response of intestinal mucosa samples to treatments with natural compounds derived from algae in terms of release of pro-inflammatory factors (1), transcriptomics, metatranscriptomics (2) and lipidomics analysis (3) (time frame: 30 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 18 Sep 2023.