Purpose of the Research

AvLB represents an IBD patient’s life-course health biography told in longitudinal data. This data is complex and messy. It is typically heterogeneous, high dimensional, high volume, incomplete, skewed, and partially corrupted. AvLB’s job is to gather and encode that data, tidy it up, and annotate it, ready for pattern analysis by ProDroma-IBD. 

AvLB aims to provide a well-stocked Data Lake for personalised IBD care. It will deal with data from two broad classes of health factors:

• Health determinants – these are factors such as food that influence health. 
• Health metrics – these are factors such as heart rate variability that measure health status. 

Our overarching goal is to develop core AvLB data structures and algorithms to cleanse, curate, and annotate datasets on patients with inflammatory bowel disease (IBD). The cleansed data would then be ready to be analysed by ProDroma-IBD, a novel AI system we are developing to predict the likely future health trajectories of IBD patients and their responses to anti-inflammatory treatments. 

During this study, we will test Emoiré pattern analysis algorithms developed to provide insights into patterns of health determinants that impact the health trajectory of individuals living with IBD. This will include ‘red’ patterns that worsen IBD flares and ‘blue’ patterns that improve the individual’s gut health.

This study will help to further translate our novel glycan biomarkers which can be used by individuals and clinicians as a prodromal signal for various inflammatory conditions. This is to enable a precision medicine approach to prevent and treat inflammatory diseases, including IBD. Our R&D partner is Ludger and blood analysis will be performed at their labs at the Culham Science Centre in Oxfordshire, UK.

To analyse your blood samples we will be using our proprietary technology –  GlyHealth.  This is an in vitro diagnostic (IVD) platform that analyses biomolecular patterns in blood (specifically quantitative glycomics signals) that correlate with the progression of general and cID-specific inflammatory processes. We will then apply our proprietary analytical models to calculate your various glycomics indices. These include GlyHealth-IBD, which measures glycomics patterns that correlate with IBD-specific chronic inflammatory processes.   

GlyHealth-IBD is our prognostic and predictive biomarker for inflammatory bowel disease (IBD). GlyHealth-IBD is at the TRL-6 development stage. GlyHealth-IBD is being co-developed by Avenna and Ludger which are sister companies based at the Culham Science Centre in Oxfordshire. Our TRL-4 and TRL-5 studies were performed in collaboration with the Translational Gastroenterology Unit (TGU) at the University of Oxford and showed that GlyHealth-IBD greatly outperforms current serological and faecal biomarkers for prognosis and prediction of IBD.

The terms ‘glycomic profiles’ and ‘glycosylation’ for GlyHealth refer to patterns of glycans that are attached to immune system proteins in blood. Glycans are complex biomolecules that modify the structures and functions of over half the proteins encoded by your body’s DNA. Glycans are now known to play critical roles in virtually every biological process in the human body, from fertilization and embryogenesis, through cell proliferation, differentiation, and development, to immunity and aging. 

The importance of glycans in human health and disease was recognised by the awarding of a Nobel Prize in 2022 to Professor Carolyn Bertozzi for her work on glycans and how they affect diseases such as cancer, inflammation, and viral infections such as COVID-19.

1. Read and sign this consent form 
2. Download the SANNO App and createyour profile by filling in questionnaire. The app is available worldwide on both, Apple Store and Play Store.   
3. You will track your symptoms, food, movement, sleep, and Bristol scale stool form via this app and automatically  share data with researchers.   
4. In addition you will have your own private portal where you can upload your health information such asprevious Test (blood tests, endoscopies, stool test, genetic tests, etc).
5. You will collect two small blood samples every three months and send them back to our labs.
6. In addition to free assessments you will also receive a special gift from Avenna’ team. 

1. We will review your application and as soon as it is approved the first blood collection kit will be sent to your address. 
2. You will receive an email with your personal folder where you can upload your health data for us to analyse and give you insights. 
3. You will start monitoring and keeping track of your daily habits which may affect your disease course: food, movement, sleep, stress and share them on a monthly basis. Sanno App will enable an automatic upload of your data. Some other apps such as Samsung health app and apple health app will require more manual upload to your personal folder in Box
4. You will need to collect two small blood samples every three months and post them to our labs

We will collect, preserve and analyse the following information as part of this research study:

General information (e.g. date of birth, gender, ethnicity, occupation and postal address – where you will be receiving the blood collection kit).  Patient-supplied Clinical Health Metric Data (including endoscopy images, serological and faecal biomarker results, inflammation markers). Patient-supplied Omics Profiles (including genomics, and longitudinal GlyHealth-IBD glycomics, epigenetic, gut microbiome, metabolomics, and proteomics profiles). Clinical Health Determinant Data (including anti-inflammatory drug regimes and other therapies). Other Patient-Supplied Data (including digital biomarkers, e.g., symptoms-tracking information from apps such as Sanno and Viocare , lifestyle information including data on food, movement, and sleep). These datasets cover the initial set of health determinants and health factors that we believe could be most useful for patients and their medics.

Your name and contact information will be stored securely for the purpose of unique sample identification but will not be used in the study. Also, no other sensitive personal information will collected from you. 

Your glycosylation analysis results along with the information provided by you (self-reported information) will be used for research purposes – which includes discovery of new traits and correlations between glycosylation profiles and health and chronic inflammation statuses. Our discoveries may be published in scientific journals or disseminated to the scientific community in other ways (e.g. presentations and talks during scientific events), as well as used as marketing material. In such cases, anonymised information, and information combined with other people’s results will be made public, and your personal information will remain private.

There are clinical methods for measuring acute inflammation in patients known as CRP (C-reactive protein). We would like to see if there is correlation between chronic inflammation as found by the glycan tests and acute inflammation as found by the CRP test. For the CRP measurement: C-reactive protein will be measured using a high sensitivity enzyme linked immunosorbent assay (ELISA) acquired from Invitrogen and compared against internationally recognised determinations of CRP levels representative of patients with non, minor and major chronic inflammation levels. To gain CRP levels we will use the same blood samples that are collected using the Lancet puncture method.