A Probiotic for Eczema Treatment

Phase 1

• Conditions: Eczema; Skin - Dermatological conditions

• Registration Number: ACTRN12616000022460
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-14
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Eligible participants will:
1. be adults (age >15-60)
2. with visible eczema according to the UK criteria and
3. 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 Criteria

1. Non-English speaking
2. Pregnant or planning to become pregnant
3. Use in the last 6 months of oral steroids
4. *Use in the last 14 days of topical or systemic antibiotics applied to eczema
5. Continuous use of systemic antibiotics over past 3 months
6 *Use of wet wraps in the last 14 days
7. 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.
8. *Use of immune suppressants such as cyclosporine, methotrexate, mycophenolate and azathioprine in the last 30 days.
9. *Use of pimecrolimus (Elidel), tacrolimus (Protopic) or ultraviolet treatment in the last 14 days.
10. **Current or planned use of probiotic supplements, applications or drinks
11. Moving from study centre during 6 weeks of study duration
12. Refusal of permission to contact health carers
13. Any other reason that deems the participant inappropriate for study
14. Has contact dermatitis only (symptoms present on hands only)
15. 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.
16. 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified