An interventional study of Metabolomics and 13C MTGT in Pancreatic Exocrine Insufficiency, sponsored by University Hospital Birmingham NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-07.
Sponsored by University Hospital Birmingham NHS Foundation Trust · Not applicable, Interventional, and Diagnostic
DETECTION. The development of a metabolomic test to diagnose and quantify pancreatic exocrine insufficiency.
Pancreatic exocrine insufficiency (PEI) is prevalent and progressive among patients with pancreatic cancer, treatment with pancreatic enzyme replacement therapy (PERT) has been proven to reduce gastrointestinal symptoms, improve quality of life and survival and is therefore recommended in NICE guidelines. Despite this, most patients with PEI do not receive PERT.
One cause for under treatment is lack of a well-tolerated and accurate diagnostic test that can provide quick results. The current, most widely used test, the faecal elastase stool test, has low accuracy, particularly after surgery, and results take several days. Furthermore, the test cannot help with dosing of PERT.
Metabolomics can be used to quantify metabolites in blood. These metabolites are directly influenced by normal digestion and absorption of food, for example blood lipid levels are very different in the fed and fasted states. This program of work will give a standard meal to healthy controls and patients with PEI and screen their blood before and after a test meal. Differences in the metabolic profile will be used to develop a 'fingerprint' of PEI based upon one metabolite or a combination of metabolites.
The ultimate goal is to develop a simple blood test that can be used outside of specialist centres that is acceptable to patients, can accurately diagnose PEI and can guide treatment with PERT.
This body of work aims to investigate the metabolome of patients with PEI (of different causes), PEI will be defined in the different cohorts by a multimodel approach with the 13C MTGT as primary reference test and FE-1 and PEI-Q used as supporting tests.
A test meal will be given to fasted participants alongside baseline blood samples and breath samples. Patients will then have blood and breath taken hourly for 6 hours. Blood samples will be spun and frozen for batch metabolomic analysis.
Inclusion Criteria: (for main pancreatic cancer cohort)
Exclusion Criteria (all arms):
investigation of PEI and the metabolome of patients with pancreatic cancer in the fed and fasted state
Diagnostic Test: Metabolomics · Diagnostic Test: 13C MTGT
investigation of PEI and the metabolome of patients with other causes of PEI in the fed and fasted state
Diagnostic Test: Metabolomics · Diagnostic Test: 13C MTGT
Investigation metabolome of patients pre and post initiation of PERT as part of their PEI care
Diagnostic Test: Metabolomics · Diagnostic Test: 13C MTGT
Plasma samples taken for the investigation of the metabolome
sequential breath samples taken for investigation of PEI (reference test)
Also known as: 13C MTG breath test
Metabolome
metabolomic fingerprint of patient with PEI in the fed and fasted state Bloods are taken in the fed and fasted state, after centrifugation, the plasma is then frozen at -80. Samples will then be analysed using untargeted liquid chromatography mass spectrometry, after which the raw data will be processed using the open-source software XCMS. The resultant metabolite features in the samples will be compared between healthy and diseased (PEI) cohorts to identify features specific to exocrine insufficiency.
Time frame: 1 year after study completion
PEI status using 13CMTGT in comparison to the metabolome
breath test (13CMTGT). 13C labelled fatty test meal ingested, exhaled breath samples eveyr hour up to 6 hours, the cumulative percent dose of 13C recovered will then be used as a marker for PEI, diagnostic under 29%
Time frame: 1 year after study completion
PEI status using FE-1 in comparison to the metabolome
FE-1. Faecal elastase, diagnostic \<200
Time frame: 1 year after study completion
PEI status using PEIQ in comparison to the metabolome
PEI-Q: Pancreatic exocrine insufficiency questionnaire (symptomatic assessment of PEI). \>1.8 severe PEI, 1.4-1.8 moderate PEI, 0.6-1.4 mild PEI
Time frame: 1 year after study completion
Response of the fed and fasted metabolome to PERT
Investigation of the metabolome in response to PERT low dose and high dose. The metabolomic profile indicative of PEI will then be assessed in a repeat cohort of patients that reattend twice on low dose and then high dose PERT. Bloods will be taken as for the main trial, in the fed and fasted state and the metabolomic profile (determined by the main cohort) will assessed using targeted liquid chromatography mass spectrometry to investigate whether it is altered by PERT (pancreatic exocrine replacement therapy)
Time frame: 1 year after study completion
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Exocrine Pancreatic Insufficiency→
University Hospital Birmingham NHS Foundation Trust