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Finger-prick Autologous Blood (FAB) for Use in Dry Mouth

NCT03530735 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-07-27

No results posted yet for this study

Summary

This is a feasibility study that will assess the efficacy of using autologous blood to treat moderate to severe dry mouth. Dry mouth has been estimated to affect up to 64.8% of the general population (Navazesh et al., 2009) and many patients that are affected by Sjögren's syndrome or have had radiation therapy to combat head or neck cancer (Navazesh et al., 2009).

The blood will be applied to the interior of the mouth by means of a mouthwash. This research poses the first potential curative treatment for dry mouth - all other current dry mouth treatments are either symptomatic or lifestyle-based.

Autologous blood has been shown to be effective in treating the epithelial surface of dry eyes. This has been attributed to the analogous growth factors in the blood to that of tears - and potentially in this case, saliva - in healing the oral epithelial surface (Herbst et al., 2004).

Conditions

  • Xerostomia
  • Xerostomia Due to Radiotherapy
  • Xerostomia Due to Hyposecretion of Salivary Gland

Interventions

OTHER

Finger-prick Autologous Blood (FAB)

Patients will be instructed to use FAB therapy by: 1. Hand hygiene with soap and water. Dry, then wipe their fingertip with an alcohol street before leaving to air dry. 2. Use a diabetic lancet to prick their cleaned fingertip. 3. Squeeze 5 drops of blood form their finger into 10ml of saline. 4. Gargle the blood-saline mixture for 5 minutes. 5. Swallow the blood-saline mixture. 6. Repeat this 4 times per day.

Sponsors & Collaborators

  • Bedford Hospital NHS Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-12-01
Completion
2019-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03530735 on ClinicalTrials.gov