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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Madeleine Williams
+44 (0)1234795787
madeleine.williams@bedfordhospital.nhs.uk


Mr Zahoor Fazili
+44 (0)1234795787
Zahoor.Fazili@bedfordhospital.nhs.uk


Prof Robert Thomas
+44(0)1234 795787
robert.thomas@bedfordhospital.nhs.uk


Study Location:

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Be Part of Research - Trial Details - Indolent prostate cancer, phytochemicals and probiotics
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Indolent prostate cancer, phytochemicals and probiotics

Recruiting

Open to: Male

Age: Mixed

Bedford

Medical Conditions

Indolent prostate cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Emerging studies are linking poor gut health (dysbiosis) with greater risk and progression of prostate cancer (PCa). Various dietary and lifestyle factors influence dysbiosis but probiotic supplements have also been shown to improve the microbiome floral to a more favourable, less inflammatory profile. Likewise, studies have linked a higher intake of phytochemical-rich foods with a lower risk of PCa and progression of prostatic specific antigen (PSA), a protein produced by the prostate gland commonly used as a biomarker for prostate cancer detection and monitoring. Phytochemicals have numerous direct and indirect anti-cancer properties, including reducing excess chronic inflammation and enhancing oxidative pathways, but they also act as prebiotics, which supports commensal and ingested probiotic bacteria. The hypothesis for this study is that a probiotic supplement could enhance the benefits of a phytochemical-rich supplement via this synergistic effect. A combination of phytochemical-rich food and probiotic supplements has not previously been explored in a cohort of men with PCa, hence the rationale for this study. The aim of this study is to establish whether boosting the diet with a lactobacillus probiotic blend in addition to a phytochemical-rich food supplement will influence PSA progression. Secondary endpoints include an assessment of prostate-related symptoms (waterworks and erectile function) and well-being measured by grip strength.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Aug 2023 01 Aug 2025

Following written informed consent, all men will be given the phytochemical-rich food supplement and asked to stop all other over-the-counter supplements. They will then be randomly assigned to take either a probiotic supplement or a placebo. The supplements will be taken twice a day for 4 months. The PSA doubling time (PSAdt), a method used to evaluate the progression and severity of prostate cancer based on changes in PSA levels over time, will be taken at baseline and 4 months together with measures of prostate symptoms and wellbeing.

The probiotic capsule will contain 10 billion colony-forming units (CFU) of 5 lactobacillus strains with built-in prebiotics. The phytochemical-rich capsule will contain whole foods which have previously reported potential benefits for men with PCa in epidemiological, laboratory and prospective studies (broccoli, green tea, pomegranate, turmeric, cranberry and ginger). The ingredients of both supplements have been shown to have a high safety profile in previous studies.


Adult men aged over 18 years old with histologically proven, early PCa, not taking androgen deprivation therapy (ADT), managed with surveillance

You can take part if:



You may not be able to take part if:


1. No histological diagnosis of prostate cancer2. Not willing to stop other over-the-counter supplements3. Patients with liver function tests more than twice the abnormal laboratory range 4. Patients with gastric or small bowel malabsorption or dysfunction 5. Patients with a known allergy to any of the trial food components.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Bedford Hospital
    Kempston Road
    Bedford
    MK42 9DJ

The possible benefits include the financial side, as men can stop all over-the-counter supplements, which many men already take - many will save money. Most men have a strong interest in nutrition and self-empowerment strategies so hopefully this study should provide welcomed information.
The possible risks include that both these food supplements have been used in previous studies with a low incidence of side effects with no significant reported adverse event. Mild abdominal Bloating occurred in 3% of participants - this is a possible side effect is this study.

Ms Madeleine Williams
+44 (0)1234795787
madeleine.williams@bedfordhospital.nhs.uk


Prof Robert Thomas
+44(0)1234 795787
robert.thomas@bedfordhospital.nhs.uk


Mr Zahoor Fazili
+44 (0)1234795787
Zahoor.Fazili@bedfordhospital.nhs.uk



The study is sponsored by Bedford Hospital NHS Trust and funded by Bedford Hospital Research Fund.




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Read full details for Trial ID: ISRCTN81939514
Last updated 06 November 2024

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