Research

Current Research Projects

All trials are different and have different levels of input from the surgery and the patient. Volunteering for involvement may mean filling in questionnaires, surveys, talking to one of the research team, attending regular appointment or trialling a new treatment or drug. Patients do not have to take part in research and can decline and withdraw at any time. Patients who are eligible to participate in a research trial will be invited by letter, text message or email. 

Our research base is at the Yatton Surgery in North Somerset, but we are active across all sites. We are a small team but growing and want to get as many patients involved in research as possible.

in the financial year 2024 / 2025 we recruited 288 patients into research studies.

If you would like to talk a member of the Research team about participating in a study, or have a query about research, or wish to permanently withdraw from any future research, please email bnssg.researchmendipvale@nhs.net.

Mendip Vale works with the CRN (Clinical Research Network) to take on and facilitate research projects of all different kinds across the year. We are currently recruiting into the following research studies:

Academic Research

Recruiting Children with Asthma and the best way for them to use their Preventer inhaler. This study will measure if the number of asthma attacks is different between children who take their preventer inhaler everyday (the “daily” group) and those who take it only when they have symptoms (the “symptom-driven group”).

 

Recruiting adults who present with Cellulitis of the leg.

The study will be assessing the effectiveness and safety of a 5-day treatment of Flucloxacillin versus the standard 7-day treatment. We also aim to evaluate the cost-consequences of a shorter course from an NHS and personal perspective.

 

(Currently running in North Somerset only)

Recruiting adult women presenting with suspected bladder (Cystitis) or kidney (Pyelonephritis) infection. The main goal is to find out the shortest amount of time we need to give antibiotics to effectively treat UTIs.

 

Recruiting people aged over 75 years who have blood pressure within a normal range and are taking two or more medications and are at a higher risk of drug-related side-effects.

This trial will establish whether deprescribing common drugs that lower blood pressure is safe in older people. We are currently still in the screening phase of this trial. We will soon be sending out invites to eligible patients.

 

Now recruiting in both Bristol and North Somerset

CORAL stands for COenzyme Q10 in heaRt fAiLure, and is a clinical trial run by the Bristol Trials Centre at the University of Bristol. A study looking at whether Coenzyme Q10 (CoQ10) improve quality of life and symptoms in heart failure. Recruiting Patients aged 18 years or over who have heart failure that impacts their daily lives. 

 

(Currently running in North Somerset only)

BRISMED aims to understand how medication reviews should be best delivered. To do this, they want to carry out the largest ever survey of patients’ experiences of medication review, as well as recording reviews and speaking to people about their experiences.

 

The INSIGHT study is an evaluation of the clinical and cost-effectiveness of the getUBetter digital health intervention for low back pain. Recruiting patients who have recently attended your practice with non-specific with low back pain.

 

OPACE aims to determine whether stopping azithromycin either completely or seasonally is no worse than continuing it in COPD patients on azithromycin or equivalent macrolides for at least 3 months.

 

Commercial Research 

Study currently recruiting participants. 

A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with type 2 diabetes, hypertension and established cardiovascular disease.  People can join the study if they have these conditions and do not have a history of heart failure.  The study is looking to recruit about 11,800 adults from around the world and the study will last for between 2.5-4.25 years.  

 

Study currently recruiting participants. 

EASi-KIDNEYTM is a clinical trial testing whether the new medication called vicadrostat, also known as BI 690517, taken in combination with a well-tested medication called empagliflozin, can be safely used to lower the risk of worsening kidney disease or heart disease in patients with kidney disease.  Vicadrostat (BI 690517) is a newly developed medicine that could provide further health benefits to people with kidney disease.  The University of Oxford’s Renal Studies Group is leading the trial.  The study is looking to recruit 11000 participants globally from about 15-20 countries and hope to present results in 2028-2029. 

 

Patient experience program currently looking for potential participants.   

The Aptamil Pepti Syneo Patient Experience Program is an observational initiative aimed at collecting valuable real-world local data on the use of Aptamil Pepti Syneo in infants with confirmed or suspected Cow’s Milk Allergy (CMA).  This program is designed to better understand aspects such as product acceptability, gastrointestinal tolerance, symptom management, parental quality of life, and overall compliance.   

Please refer to research team if your patient is potentially eligible and is interested to try on this formula provided by Nutricia. 

The study is looking into a formula for infants with cow’s milk allergy. The new formula is a hydrolysed rice protein formula. The study will compare the new formula to a standard formula already available to children with cow’s milk allergy. 

Research Outcomes

Atlantis

Atlantis research aim was to assess the clinical effectiveness of low-dose amitriptyline (10–30mg) for adults with IBS in primary care.

Eligible participants were aged 18 years or over with IBS of any subtype, ongoing symptoms despite dietary changes and first-line therapies, and no contraindications to amitriptyline. They had a normal full blood count and C-reactive protein, negative coeliac serology, and no evidence of suicidal ideation.

Participants were randomised to low-dose oral amitriptyline or placebo for 6 months.

Participants, their general practitioners (GPs), investigators, and the analysis team were masked to treatment allocation. The primary outcome was the IBS Symptom Severity Score (IBS-SSS) at 6 months. A key secondary outcome was subjective global assessment of relief of IBS symptoms at 6 months.

Research Findings

This is the largest trial of a tricyclic antidepressant in IBS ever conducted. Titrated low-dose amitriptyline was superior to placebo for IBS across multiple endpoints and was safe.

Primary care clinicians can offer low-dose amitriptyline to patients with IBS whose symptoms do not improve with first-line therapies, with appropriate support to guide patient-led dose titration, such as using the self-titration document developed for this trial. Low-dose amitriptyline could be added to first-line therapies already being taken by patients, as it was in this trial.

BEE

Bee (Best Emollient for eczema) research aim was to compare the clinical effectiveness and safety of the four main emollient types: lotions, creams, gels, and ointments.

Children aged between 6 months and 12 years with eczema were randomly assigned to lotions, creams, gels, or ointments. The initial emollient prescription was for 500 g or 500 mL, to be applied twice daily and as required. The primary outcome was for parents to report the eczema severity over 16 weeks.

Research Findings

We found that there was no difference in effectiveness between the four main types of emollients for childhood eczema. As such users need to be able to choose from a range of emollients to find one that they are more likely to use effectively.

Safa

Safa research aim was to assess the effectiveness of oral spironolactone for acne vulgaris in adult women.

Participants were randomly assigned (1:1) to either 50 mg/day spironolactone or matched placebo until week six, increasing to 100 mg/day spironolactone or placebo until week 24. Participants could continue using topical treatment. Topical treatments are applied directly to the skin to reduce inflammation and irritation.

Research Findings

Spironolactone improved outcomes compared with placebo, with greater differences at week 24 than week 12. Spironolactone is a useful alternative to oral antibiotics for women with acne.