Enterosgel® in the treatment of atopic dermatitis in adults (v.1.0)
Research type
Research Study
Full title
Randomised, multi-centre study to assess efficacy, tolerability and safety of Enterosgel® in the treatment of acute atopic dermatitis in adults
IRAS ID
221883
Contact name
Preeti Pandya
Contact email
Sponsor organisation
Enteromed Ltd
ISRCTN Number
ISRCTN12307286
Clinicaltrials.gov Identifier
PRIM 5338, NIHR
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Title: Enterosgel® in the treatment of atopic dermatitis in adults\n\nMany people suffer from acute atopic skin conditions every year in the UK. Research suggests that intestinal bacteria might play a role in the development of atopic skin conditions. In some European countries, intestinal adsorbents which remove harmful substances such as bacterial toxins from the gut, are used in the treatment of skin conditions. One of these products is Enterosgel®, which is available over-the-counter in the UK for treatment of stomach conditions such as diarrhoea. We are conducting this study to investigate the potential benefits of using Enterosgel® in the treatment of atopic dermatitis. We will also investigate if certain factors in plasma are linked to the severity of dermatitis and response to treatment.\n\n44 adult patients with acute manifestations of dermatitis will be recruited at medical practices in the UK. 22 patients will receive Enterosgel® in addition to standard treatment. 22 patients will be in the control group and receive standard treatment only. Duration of the study is 4 weeks and involves attending two study visits (Days 0, 14) at the medical practice and four phone calls (Days 3, 7, 21, 28).\n\nDuring the visits, the doctor will assess skin symptoms using the SCORing Atopic Dermatitis (SCORAD) tool, which calculates a score based on severity and spread of the symptoms. Patients will also fill a questionnaire called the Patient-Oriented Eczema Measure (POEM) and give a tube of blood at both visits. Plasma will be separated from the blood sample and analysed for allergic antibodies, bacterial toxins and a specific inflammatory factor. During the calls the nurse will go through the POEM questionnaire, and ask about other symptoms, treatment use, and any side effects recorded in patient diary. \n\nThe study is funded by Bioline Products s.r.o., who are the manufacturer of Enterosgel®.
REC name
North West - Preston Research Ethics Committee
REC reference
17/NW/0131
Date of REC Opinion
3 Apr 2017
REC opinion
Further Information Favourable Opinion