IBS - Irritable Bowel SyndromeNCT05434949
Pre-analytical Influences on a Blood Test Study
An observational study of IBS - Irritable Bowel Syndrome, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Chronic diarrhoea is common and often believed to result from irritable bowel syndrome (IBS). However, up to 50% of patients with an IBS diagnosis may have something called Bile Acid Diarrhoea (BAD) instead. BAD is easily treatable however diagnosis currently relies on a complex test involving two full body scans. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Blood test and Analyses of samples
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Dec 2022to 15 Nov 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers from the BCPS and patients attending hospital as part of their standard care.
Who may be able to join
- Part 1: Effect of food intake on C4
- Healthy adult (>=18 years) volunteers from the BCPS.
- Part 2: Effect of Lipid-lowering therapy on C4
- There is no patient recruitment. Spare sample collected from patients before and after starting on lipid-lowering therapy will be used.
Who cannot join
- Part 1: Effect of food intake on serum C4
- Subjects with learning disability or those lacking mental capacity to give consent.
- Pregnant or breast-feeding
- On (prescribed and over-the-counter) medication and herbal remedies known or considered to affect lipid and bile acid metabolism.
- Chronic and acute diarrhoea
- Gastrointestinal disease.
Show all 17Show fewer
- Previous ileal resection or cholecystectomy
- Obesity defined as a body mass index (BMI) of greater than 29.9 kg/m2
- Part 2: Effect of Lipid-lowering therapy on C4
- The surplus serum will not be analysed if any of the following apply to the patient:
- Pregnant or breastfeeding for either time point
- Lipid lowering therapy within the last 6 months for the first sample
- On (prescribed and over-the-counter) medication and herbal remedies known or considered to affect lipid and bile acid metabolism.
- Chronic and acute diarrhoea
- Gastrointestinal disease.
- Previous ileal resection or cholecystectomy
- Obesity defined as a body mass index (BMI) of greater than 29.9 kg/m2
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Wolverhampton NHS Trust
Wolverhampton, West Midlands, WV10 0QP
About this study
Official title: Effect of Post-prandial State, Statins and PCSK9 Inhibitors on Serum 7a-hydroxy-4-cholesten-3-one Concentration
Chronic diarrhoea is common and often believed to result from irritable bowel syndrome (IBS). However, up to 50% of patients with an IBS diagnosis may have something called Bile Acid Diarrhoea (BAD) instead. BAD is easily treatable however diagnosis currently relies on a complex test involving two full body scans. The aim of the study is therefore to investigate whether a simple laboratory test, that can be done on a single blood sample, would be appropriate instead. This laboratory test is called 7aC4.
In order to determine whether 7aC4 could be a good test for BAD, it needs to be determined whether eating a meal can alter the levels of 7aC4. The aim of this study is to measure 7aC4 at several time points before and after eating a meal, to see what effect this has on 7aC4 levels.
Read the detailed description
Chronic diarrhoea is common and largely due to irritable bowel syndrome (IBS). IBS is reported to affect about 11% of the UK population. About half these patients are believed, however, to have bile acid diarrhoea (BAD). There are, therefore, more than one million patients with BAD in the UK. BAD is caused by small bowel malabsorption of bile acids (BA) and increased BA in the large intestine cause diarrhoea. Once diagnosed, the treatment of BAD is simple and effective. BAD, however, is often not diagnosed because of a lack of easily available and reliable diagnostic methods.
In the UK, the radiolabelled 23-seleno-25-homotaurocholic acid test (SeHCAT) is the gold-standard diagnostic method. The SeHCAT is performed by oral administration of a radiolabel, followed by two full-body scans, one week apart, to assess retention of BA. A low retention time indicates BAD. SeHCAT, however, is expensive, inconvenient to the patient, exposes the patient to radiation and has limited availability. A simple laboratory biomarker for the diagnosis of BAD is, therefore, desirable.
Proposed diagnostic laboratory biomarkers for BAD include measurement of faecal BA and serum 7a-hydroxy-4-cholesten-3-one (C4). C4, an intermediate in the BA synthesis pathway, is the common precursor for the primary BAs. It is, therefore, utilised as a biomarker of BA synthesis. Serum C4 increases in BAD, as BA synthesis increases to compensate for the increased faecal BA loss. C4 measurement requires a single serum sample for analysis by liquid chromatography tandem mass spectrometry (LC-MS/MS). There is, however, limited data comparing its diagnostic accuracy to the SeHCAT scan. Furthermore, pre-analytical variables which may affect C4, include cholesterol lowering medication, diurnal variation and effects of food intake require clarification to optimise conditions for sample collection before its introduction into routine laboratory use. Literature suggests both diurnal variation and post-prandial response can influence C4 levels, however there is limited information on whether this is primarily a post-prandial response, or due to diurnal variation. This study aims to compare pre- and post-prandial C4 levels, controlled for diurnal variation.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Blood test, Analyses of samples
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Three blood samples to be taken at 08.00, 10.00 and 12.00 on day 1 of the study.
The following day, after an overnight fast, a blood sample will be taken at 8.00, followed by a standardized breakfast provided by the study team at 8.30, and then two further blood samples at 10.00 and 12.00.
Analyses of samplesOther
C4 will be measured in surplus serum from 30 adult lipid patients before starting on lipid-lowering therapy (either statin of PCSK9 therapy) and then again 3 months after starting on therapy. Blood samples will be collected as part of routine lipid management, no additional samples are required.
| Study group | Role | What they receive |
|---|---|---|
| Effect of food intake on C4 | Blood tests to analyse serum C4 pre, and 2 and 4 hours post a standardised meal, and the same 10 patients to analyse serum C4 at 0, 2 and 4 hours, all fasting. Receives: Diagnostic Test: Blood test | |
| Effect of Lipid-lowering therapy on C4 | Spare sample collected from patients before and after starting on lipid-lowering therapy will be used to measure C4 before and after lipid-lowering therapy. Receives: Other: Analyses of samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum C4 will be measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) to measure increase/ decrease by diurnal variation and food intake.
Serum C4 will be measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) to measure increase/ decrease by diurnal variation and food intake.
Measured: 12 months
Measure increase/decrease in Serum C4 levels after taking lipid lowering therapy (statins / PCSK9 inhibitors).
Measure increase/decrease in Serum C4 levels after taking lipid lowering therapy (statins / PCSK9 inhibitors).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Dec 2022
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434949
- Sponsor's protocol ID
- 2022LAB126
- Status last verified
- Jan 2025
- First submitted
- 1 Jun 2022
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Post-prandial State, Statins and PCSK9 Inhibitors on Serum 7a-hydroxy-4-cholesten-3-one Concentration
- ClinicalTrials.gov ID
- NCT05434949
- Acronym / sponsor ID
- 2022LAB126
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- The Royal Wolverhampton Hospitals NHS TrustOther government
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 28 Jun 2022 (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.
Chronic diarrhoea is common and often believed to result from irritable bowel syndrome (IBS). However, up to 50% of patients with an IBS diagnosis may have something called Bile Acid Diarrhoea (BAD) instead. BAD is easily treatable however diagnosis currently relies on a complex test involving two full body scans. The aim of the study is therefore to investigate whether a simple laboratory test, that can be done on a single blood sample, would be appropriate instead. This laboratory test is called 7aC4.
In order to determine whether 7aC4 could be a good test for BAD, it needs to be determined whether eating a meal can alter the levels of 7aC4. The aim of this study is to measure 7aC4 at several time points before and after eating a meal, to see what effect this has on 7aC4 levels.
Detailed description
Chronic diarrhoea is common and largely due to irritable bowel syndrome (IBS). IBS is reported to affect about 11% of the UK population. About half these patients are believed, however, to have bile acid diarrhoea (BAD). There are, therefore, more than one million patients with BAD in the UK. BAD is caused by small bowel malabsorption of bile acids (BA) and increased BA in the large intestine cause diarrhoea. Once diagnosed, the treatment of BAD is simple and effective. BAD, however, is often not diagnosed because of a lack of easily available and reliable diagnostic methods.
In the UK, the radiolabelled 23-seleno-25-homotaurocholic acid test (SeHCAT) is the gold-standard diagnostic method. The SeHCAT is performed by oral administration of a radiolabel, followed by two full-body scans, one week apart, to assess retention of BA. A low retention time indicates BAD. SeHCAT, however, is expensive, inconvenient to the patient, exposes the patient to radiation and has limited availability. A simple laboratory biomarker for the diagnosis of BAD is, therefore, desirable.
Proposed diagnostic laboratory biomarkers for BAD include measurement of faecal BA and serum 7a-hydroxy-4-cholesten-3-one (C4). C4, an intermediate in the BA synthesis pathway, is the common precursor for the primary BAs. It is, therefore, utilised as a biomarker of BA synthesis. Serum C4 increases in BAD, as BA synthesis increases to compensate for the increased faecal BA loss. C4 measurement requires a single serum sample for analysis by liquid chromatography tandem mass spectrometry (LC-MS/MS). There is, however, limited data comparing its diagnostic accuracy to the SeHCAT scan. Furthermore, pre-analytical variables which may affect C4, include cholesterol lowering medication, diurnal variation and effects of food intake require clarification to optimise conditions for sample collection before its introduction into routine laboratory use. Literature suggests both diurnal variation and post-prandial response can influence C4 levels, however there is limited information on whether this is primarily a post-prandial response, or due to diurnal variation. This study aims to compare pre- and post-prandial C4 levels, controlled for diurnal variation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effect of food intake on C4 | – | Diagnostic Test: Blood testBlood tests to analyse serum C4 pre, and 2 and 4 hours post a standardised meal, and the same 10 patients to analyse serum C4 at 0, 2 and 4 hours, all fasting. |
| Effect of Lipid-lowering therapy on C4 | – | Other: Analyses of samplesSpare sample collected from patients before and after starting on lipid-lowering therapy will be used to measure C4 before and after lipid-lowering therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers from the BCPS and patients attending hospital as part of their standard care.
Key inclusion criteria (4 listed)
- Part 1: Effect of food intake on C4
- Healthy adult (>=18 years) volunteers from the BCPS.
- Part 2: Effect of Lipid-lowering therapy on C4
- There is no patient recruitment. Spare sample collected from patients before and after starting on lipid-lowering therapy will be used.
Key exclusion criteria (17 listed)
- Part 1: Effect of food intake on serum C4
- Subjects with learning disability or those lacking mental capacity to give consent.
- Pregnant or breast-feeding
- On (prescribed and over-the-counter) medication and herbal remedies known or considered to affect lipid and bile acid metabolism.
- Chronic and acute diarrhoea
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 |
|---|---|---|
| Blood testThree blood samples to be taken at 08.00, 10.00 and 12.00 on day 1 of the study. The following day, after an overnight fast, a blood sample will be taken at 8.00, followed by a standardized breakfast provided by the study team at 8.30, and then two further blood samples at 10.00 and 12.00. | Diagnostic test | Effect of food intake on C4 |
| Analyses of samplesC4 will be measured in surplus serum from 30 adult lipid patients before starting on lipid-lowering therapy (either statin of PCSK9 therapy) and then again 3 months after starting on therapy. Blood samples will be collected as part of routine lipid management, no additional samples are required. | Other | Effect of Lipid-lowering therapy on C4 |
Primary outcome
Serum C4 will be measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) to measure increase/ decrease by diurnal variation and food intake.
Time frame: 12 months
Serum C4 will be measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) to measure increase/ decrease by diurnal variation and food intake.
Measure increase/decrease in Serum C4 levels after taking lipid lowering therapy (statins / PCSK9 inhibitors).
Time frame: 12 months
Measure increase/decrease in Serum C4 levels after taking lipid lowering therapy (statins / PCSK9 inhibitors).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- 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.
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 IBS - Irritable Bowel Syndrome, run by The Royal Wolverhampton Hospitals NHS Trust at 1 site in United Kingdom.
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 4 inclusion and 17 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: finished, as of the sponsor's last update on 15 Jan 2025. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum C4 will be measured by liquid chromatography tandem mass spectrometry (LC-MS/MS) to measure increase/ decrease by diurnal variation and food intake. (time frame: 12 months). The study lists 2 primary outcomes in all. 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 15 Jan 2025.