From Nature to Bedside- Algae Based Bio Compound for Prevention and Treatment of Inflammation, Pain and IBD

NCT ID: NCT06042582

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-05-01

Brief 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 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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)

Additional biopsies collection

Intervention Type: PROCEDURE

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.

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)

Additional biopsies collection

Intervention Type: PROCEDURE

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.

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

Additional biopsies collection

Intervention Type: PROCEDURE

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.

Interventions

Additional biopsies collection

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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:

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Silvio Danese

Director of Gastroenterology and Endoscopy Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Algae4IBD

Identifier Type: -

Identifier Source: org_study_id