Do nanobubbles improve joint hypoxia?
Research type
Research Study
Full title
An investigation of whether orally delivered nanobubbles have a physiological effect on joint hypoxia?
IRAS ID
281338
Contact name
Duncan Richards
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Research Summary
Inflamed joints in patients with rheumatoid arthritis and psoriatic arthritis are characterized by low oxygen levels and inflammation. We propose to investigate whether drinking tiny bubbles (nanobubbles) would improve oxygen level in joints leading to anti-inflammatory effects. If it does then with further research this could represent a new treatment for patients.
20 rheumatoid and psoriatic arthritis patients with swollen joint(s) will be recruited to be randomized to drink either nanobubbles or citrus flavoured drinks, twice a day for 28 days. At the start and end of intervention, I will collect blood samples, as well as joint fluid and tissues. I will examine these samples to identify changes in oxygen levels, and which cells and systems are responding to the intervention. If successful, this will allow us to design a future clinical trial that will look at patient benefit
Summary of Results
Inflammatory arthritis is associated with low levels of oxygen in joints (hypoxia) and this may play a role in how the disease develops.
Before this study we observed in the lab and in humans that nanobubbles are able to transport gas and thus may be able to relieve joint hypoxia.
Since the start of the study we have undertaken additional laboratory investigations of the nanobubbles. These showed that the gas related effects of the nanobubbles are dependent on uptake of the bubbles into cells. The uptake of nanobubbles between different cell types is very different.
The main measure in this study was the oxygen level in the joint and this new information suggests a benefit of the kind we were looking for was unlikely . We therefore decided to close this study before any subjects took part.
We consider that nanobubbles have the potential to deliver a therapeutic effect but the new data indicate a different study design will be required. We will continue to investigate in the laboratory and make a new study proposal in the future based on this updated information.
No subjects were enrolled and therefore there is no study data to report.REC name
London - Riverside Research Ethics Committee
REC reference
21/LO/0030
Date of REC Opinion
12 Feb 2021
REC opinion
Further Information Favourable Opinion