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

July 26, 2018 updated by: Bedford Hospital NHS Trust

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Fingerprick autologous blood (FAB) has been demonstrated to be effective in treating dry eye disease by inducing healing of the epithelial surface of the eye (Than et al., 2017). The epithelial layers of both the mouth and the eye require a non-vascular source of lubrication and nutrients (tears and saliva respectively). These nutrients include growth factors - naturally occurring substances capable of stimulating cellular growth. Saliva provides transforming growth factor alpha (TGF - α) (Mogi et al., 1995), epidermal growth factor (EGF) (Herbst, 2004; Marti et al., 1989), and Hepatocyte growth factor (HGF) (Amano et al., 1994) whilst tears provide EGF (Ohashi et al., 1989) amongst others (including TGF -β 1 and 2 (Gupta et al., 1996) integral to the proliferation, survival and differentiation of the oral epithelial cells (Klenkler et al., 2007). Therefore, as severe dry mouth disease (and a subsequent lack of saliva and growth factors) causes damage to the epithelial surface lining the mouth, a growth factor rich saliva substitute like FAB, should be an effective treatment for dry mouth. There is currently no study which details FAB for use in dry mouth.

Whole or parts of the three major salivary glands have been surgically transplanted or redirected to provide a replacement tear film in patients with severe dry eyes. This has been shown to be successful in both lubricating and improving eye comfort in afflicted patients (Geerling & Sieg, 2008). Since both blood and saliva have been shown to be effective as tear substitutes, it stands to reason that both tears and blood may be effective as a saliva substitute. Both tears and saliva are extraordinarily complex blood derived biological products which provide nourishment to an epithelial surface, and as such, blood should serve as a sufficiently close mimic of saliva.

Sjögren's syndrome, a chronic systemic autoimmune disease, occurs due to infiltration of secretory (exocrine) glands including the eye and mouth, resulting in dry eye and mouth respectively. FAB has been shown to be effective in treating Sjögren's induced dry eye and logically should also be an efficacious treatment for Sjögren's induced dry mouth.

Currently no curative measures for dry mouth exist. Oral dryness is managed conservatively by providing lubrication through a temporary solution such as lifestyle changes, artificial sprays, dry mouth mouthwash solutions or sialagogues (Shirlaw & Khan, 2017). There is no treatment that addresses the complexity of salivary constituents. Oral pilocarpine can be used to stimulate salivary glands at least as effectively as artificial saliva, however side effects were high including sweating, urinary frequency and vasodilation (Davies & Thompson, 2015).

Thus, FAB offers a potentially novel and better way than currently prescribed methods to treat dry mouth disease.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Patients diagnosed with dry mouth and are on or have refused treatment e.g. spray or mouthwash

Exclusion Criteria:

  • Patients who do not have capacity to consent
  • Patients with immunodeficiency
  • Infected finger or systemic infection or on systemic antibiotics for infection
  • Patients with active microbial infection, acute herpes simplex, herpes zoster or infected mouth ulcers
  • Pregnant or breast feeding women
  • Fear of needles and unwillingness to carry out repeated finger pricks
  • Patients with frank oral ulceration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fingerprick Autologous Blood (FAB) for Use in Dry Mouth

All patients recruited will receive a 10ml saline mouth wash. Half will produce a blood-saline mixture from this mouthwash (preparation details below) and the other half will only use standard saline mouthwash. Each group will use their respective mouthwash 4 times a day for 4 weeks. During the following 4 weeks, participants will use the other mouthwash treatment. In the final 4 weeks, neither group of patients will be using either mouthwash.

Patients will be assessed at week 0, 2, 4, 6, 8, 10 and 12. However only clinic visits 0, 4, 8 and 12 will require clinic visits. During weeks 2, 6, and 10 the patients will fill out the questionnaire at home.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of signs of clinical dry mouth
Time Frame: 6 months
To assess improvement of signs of dry mouth using the Challachombe scale for visual identification and quantification of dry mouth
6 months
Improvement of symptoms of Dry Mouth
Time Frame: 6 months
To assess improvement of signs of dry mouth using the seven item Xerostomia index.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence Self Report Questionnaire to assess patient compliance
Time Frame: 12 months
We will create a questionnaire to assess patient adherence to apply fresh autologous blood during the study and after the study period has ceased. There will also be questions on patient comfort and thoughts on the application process.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bedford Hospital NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

May 8, 2018

First Posted (ACTUAL)

May 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRAS 228680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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