TerminatedPhase 1ACTRN12616000022460

A Probiotic for Eczema Treatment

Safety testing of the probiotic, M. luteus Q24 for eczema treatment

Sponsor

University of Otago

Enrollment

40 participants

Start Date

Oct 3, 2016

Study Type

Interventional

Conditions

Eczema

Summary

Eczema is a major problem among New Zealand children, particularly among Maori and Pacific peoples where infected eczema is a leading cause of hospitalization. We plan to safety test a lysate of Micrococcus luteus Q24 as an eczema treatment. This lysate is from a bacterium that naturally occurs on the skin. There is evidence that it has both anti-inflammatory and antibacterial properties and thus offers a natural alternative to topical steroids and antibiotics, important given the well-recognized global problem of antibiotic resistance. This will pave the way for a larger test of efficacy and a new way of managing eczema.

Eligibility

Sex: Both males and femalesMin Age: 16 YearssMax Age: 60 Yearss

Inclusion Criteria4

Eligible participants will:
be adults (age >15-60)
with visible eczema according to the UK criteria and
an Eczema Area and Severity Index (EASI) value >=2 to exclude minor eczema or <=50 to exclude those with very severe eczema whose symptoms may worsen if their treatment regime changes.

Exclusion Criteria18

Non-English speaking
Pregnant or planning to become pregnant
Use in the last 6 months of oral steroids
*Use in the last 14 days of topical or systemic antibiotics applied to eczema
Continuous use of systemic antibiotics over past 3 months
*Use of wet wraps in the last 14 days
A severe systemic disorder e.g. renal failure, heart disease, cystic fibrosis, immunodeficiency, muscular dystrophy or cancer where in the opinion of the investigator participation is inappropriate.
*Use of immune suppressants such as cyclosporine, methotrexate, mycophenolate and azathioprine in the last 30 days.
*Use of pimecrolimus (Elidel), tacrolimus (Protopic) or ultraviolet treatment in the last 14 days.
**Current or planned use of probiotic supplements, applications or drinks
Moving from study centre during 6 weeks of study duration
Refusal of permission to contact health carers
Any other reason that deems the participant inappropriate for study
Has contact dermatitis only (symptoms present on hands only)
Has a known intolerance to Cetomacrogol, as this is the ointment used as a base in both the active and placebo arms of the trial.
Has past reaction to soya or dairy foods and avoids eating either of these.
Recruitment may occur at a later date if these treatments can be avoided for the specified time.
Recruitment may occur if probiotics are stopped for 2 weeks and a commitment is made not to recommence them for the study duration

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Interventions

Micrococcus luteus Q24 will be cultured to achieve a concentration of 10^7-8 cfu/gram. The Q24 cells will be killed so only the metabolites remain and then formulated as an ointment using a Cetomacrogol base, a peony perfume and carotene for colour.. There will be a 5% concentration of the killed bacteria in the final ointment. The actual volume used will depend on the extent of the eczema and the size of the body . Initially active, placebo and Cetomacrogol ointment will each be applied as open tests to healthy unaffected skin on vertical sites (3 square cm) of the mid-upper back of each individual participant.. Skin reactions will be monitored every 15 minutes for 1 hour by the study investigator. If there are no reactions to the open test, the active, placebo, Cetomacrogol ointments and a saline control will be applied to a different site of healthy skin on one side of the spine using patch tests. Patches will be removed after 48 hours by the participant and read 72 hours later by study investigator. Providing there are no adverse reactions following the open and patch tests on healthy skin, the study investigator will test the ointment that the participant will be randomised to on eczematous skin of each individual. The participant will be observed by the study investigator for 1 hour following the application to eczematous skin. If there are no adverse reactions, participants will be provided with the appropriate ointment to apply thinly each day on all eczema sites on their body and one non-eczema skin site for a period of 4 weeks. There are no washout periods between the different tests, as each test is to be conducted in a different location of the body. Participants will be asked to keep a daily record of their use of the study ointment.