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Do Nanobubbles Improve Joint Hypoxia?

Study Purpose

Inflamed joints in patients with rheumatoid arthritis and psoriatic arthritis are characterized by low oxygen levels and inflammation. We propose to investigate whether tiny bubbles (nanobubbles) when given in a drink can alter oxygen level in joints. These nanobubbles are so small that they can enter the bloodstream when given as a drink. This information will give new information on the role of oxygen in joint inflammation and could possibly lead to new treatment approaches in the future.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - • Participant is willing and able to give informed consent for participation in the study.
  • - Male or Female, aged 18 years or above.
  • - Fulfil American College of Rheumatology/European League Against Rheumatism criteria (ACR/EULAR) 2010 Rheumatoid Arthritis Classification Criteria or fulfil Classification Criteria for Psoriatic Arthritis 2006 (CASPAR).
  • - Selected joint for biopsy must be minimum Grade 2 synovial thickening for large joint (knee) and medium joint (wrist), or minimum Grade 3 synovial thickening for small joint (metacarpophalangeal).
  • - Women of child bearing potential who are willing to use effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the duration of the study.

Exclusion Criteria:

  • - • Currently on oxygen therapy.
  • - Current enrolment in any other clinical study involving an investigational study treatment.
  • - Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding.
  • - Intramuscular, intravenous or intra-articular administration of corticosteroid within 4 weeks prior to baseline visit.
  • - Oral corticosteroid > 10 mg/day prednisolone or equivalent within 4 weeks prior to baseline visit.
  • - Oral corticosteroid dose not stable for at least 4 weeks prior to baseline visit.
  • - Oral non-steroidal anti-inflammatory drugs (including aspirin > 75 mg/ day and selective-cyclooxygenase inhibitors) dose not stable for at least 4 weeks prior to baseline visit.
  • - Disease modifying anti-rheumatic drugs (DMARDs) dose not stable for at least 4 weeks prior to baseline visit.
  • - History of septic arthritis.
  • - Participants on warfarin, heparin, low molecular weight heparin, direct oral anticoagulants.
Oral anti-platelet agents are permitted.
  • - History of haemophilia.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04844008
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Oxford
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis, Psoriatic Arthritis
Arms & Interventions

Arms

Experimental: Nanobubble

Sports drink nanobubble drink

Placebo Comparator: control

Flavoured drink- no active ingredients

Interventions

Dietary Supplement: - Nanobubble drink

Commercially available sports drink

Contact a Trial Team

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International Sites

Oxford University Hospitals NHS Trust, Oxford, United Kingdom

Status

Recruiting

Address

Oxford University Hospitals NHS Trust

Oxford, , OX3 7LD

Site Contact

Shing Law

Shing.law@ndorms.ox.ac.uk

01865737882

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