Probiotics in Paget's Disease
Research type
Research Study
Full title
Probiotics in Paget's Disease
IRAS ID
303256
Contact name
Stuart Ralston
Contact email
Sponsor organisation
University of Edinburgh
ISRCTN Number
ISRCTN12180483
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Paget's disease of the bone (PDB) is a skeletal disorder with a strong genetic component which can be associated with various complications such as pain, bone deformity, arthritis and deafness. Although genetic factors play an important role in PDB, environmental influences also contribute. Many environmental triggers have been proposed as triggers for PDB including viral infections, calcium and vitamin D deficiency, mechanical loading, exposure to environmental toxins and changes in diet. A factor that has not yet been studied are the potential effects of the intestinal microbiome in PDB. The microbiome has been found to play an important role in regulating bone metabolism in both preclinical and clinical studies. It has also been found that self-reported low dietary intakes of calcium during childhood are associated with an increased risk of developing Paget's disease. No intervention studies have been performed to investigate the effects of probiotics or calcium and vitamin D supplements in PDB. The aim of this study is to conduct a randomised controlled trial to investigate whether administration of probiotics or dietary calcium and vitamin D supplements can favourably influence biochemical markers of disease activity or symptoms in patients with PDB.
REC name
West of Scotland REC 3
REC reference
22/WS/0075
Date of REC Opinion
5 Aug 2022
REC opinion
Further Information Favourable Opinion