Ask to take part

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:

Prof Stuart Ralston
+44 (0)1316518741
stuart.ralston@ed.ac.uk


Ms Kathryn Berg
+44 (0)1316518755
kathryn.berg@ed.ac.uk


Ms Kathryn Berg
+44 (0)1316518755
kathryn.berg@ed.ac.uk


Study Location:

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Be Part of Research - Trial Details - Probiotics in Paget's disease

Probiotics in Paget's disease

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Paget's disease of bone


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.


Epidemiological studies have shown that environmental factors influence the occurrence and severity of Paget’s disease of bone (PDB), but the identity of these factors is unclear. There is previous evidence that dietary calcium and vitamin D deficiency might predispose to PDB. The study will investigate the role of dietary calcium and vitamin D and of the microbiome as environmental factors which may modify the disease activity in PDB. The aim of this study will be to explore the effects of dietary calcium and vitamin D supplements and probiotic supplements on biochemical markers of metabolic activity in patients with mild PDB who are not considered to require treatment with bisphosphonate therapy and to study effects on pain and quality of life.

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:

16 Feb 2024 31 Jul 2025

The study involves three hospital visits at baseline, 3 months and 6 months. Participants will be allocated to a treatment group and will receive either probiotics, combined vitamin D and calcium supplements, or a placebo. Participants will give a blood sample and a stool sample at each visit and will answer questions related to their quality of life and the presence of pain.


Adult patients with PDB

You can take part if:



You may not be able to take part if:


1. Unable or unwilling to give informed consent2. Bisphosphonate therapy thought to be indicated for the treatment of Paget's disease of the bone on clinical grounds3. Currently being treated with bisphosphonates, denosumab or calcitonin for any reason4. Currently being treated with combined calcium and vitamin D supplements5. Treatment with oral or intravenous bisphosphonates during the previous 24 months6. Treatment with denosumab during the past 12 months7. Treatment with calcitonin during the previous 3 months.8. Treatment with combined calcium and vitamin D supplements during the past 4 weeks9. Receiving probiotics during the previous 3 months


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

  • Nottingham City Hospital
    Hucknall Road
    Nottingham
    NG5 1PB
  • Queen Elizabeth University Hospital
    1345 Govan Road
    Glasgow
    G51 4TF
  • Western General Hospital
    Crewe Road South Edinburgh
    Lothian
    EH4 2XU
  • The James Cook University Hospital
    Marton Road
    Middlesbrough
    TS4 3BW
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Freeman Hospital Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Leicester Royal Infirmary
    Infirmary Square
    Leicester
    LE1 5WW
  • Salford Royal Hospital
    Stott Lane Eccles
    Salford
    M6 8HD
  • University Hospital Llandough
    Penlan Road Llandough
    Penarth
    CF64 2XX
  • Royal Liverpool and Broadgreen University Hospitals NHS Trust
    Royal Liverpool University Hospital Prescot Street
    Liverpool
    L7 8XP
  • Royal National Orthopaedic Hospital
    Brockley Hill
    Stanmore
    HA7 4LP

There are no benefits to taking part in this study, but the results from this study might help to improve understanding of the causes of PDB and help in the search for new treatments. It is unlikely that taking the supplements will cause any side effects, but we will be monitoring all participants closely for any adverse effects that might occur.


The study is sponsored by Accord (United Kingdom) and funded by H2020 European Research Council.




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Read full details for Trial ID: ISRCTN12180483
Last updated 05 December 2024

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