Efficacy of ENTEROSGEL in managing acute atopic skin conditions

• Research type

  Research Study

• Full title

  Efficacy of ENTEROSGEL in managing of acute atopic skin conditions in children and adults

• IRAS ID

  199462

• Contact name

  Ekaterina Burova

• Contact email

  ekaterina.burova@bedfordhospital.nhs.uk

• Sponsor organisation

  ENTEROMED

• Clinicaltrials.gov Identifier

  PRIM-5338, NIHR

• Duration of Study in the UK

  0 years, 2 months, 1 days

• Research summary

  This is a post-market follow-up for medical device
  Study Design: Multi-centered
  Allocation: Randomized, Controlled
  Endpoint Classification: Efficacy Study
  Masking: Open
  Primary Purpose: Treatment

  Title:
  Efficacy and safety of ENTEROSGEL in the Treatment of Acute Atopic Skin Conditions in Children and adults.

  BACKGROUND AND RATIONALE:

  The Gastrointestinal (GI) tract plays one of the essential roles in pathogenesis of allergic diseases and atopic skin conditions. Decreased enzyme activity, disruption of intestinal motility, poor digestion and malabsorption lead to increased intestinal permeability to toxic compounds and macromolecules, which can lead to sensitization of the immune system. For this reason as part of a comprehensive treatment of various diseases in allergy and dermatology, it is highly desirable to cleanse and protect the GI tract and normalize the intestinal microflora. These requirements are met by Enterosgel – an innovative intestinal adsorbent with a high sorption capacity towards endo-toxins and other medium-weight molecular harmful substances, a protective effect on the intestinal mucous membrane and a positive influence on the intestinal microflora.

  Intestinal adsorbent ENTEROSGEL was clinically proven in previous studies abroad to shorten the length of the duration of acute skin condition and normalise the IgE level. It is a CE marked medical device class IIA for children and adults available as an OTC in 20 countries and now in the UK pharmacies and health stores. The study objective is to prove it's efficacy in treatment of the acute skin conditions, like atopic dermatitis and eczema. Introducing Enterosgel into the treatment scheme can reduce the duration of the treatment, amount of medications, reducing the burden from GP and the NHS cost for managing allergy conditions. The study will be submitted for publishing in the UK and for inclusion into the NICE guidance.
  Based on the power calculation we plan to recruit 60-200 patients for both arms.
  We have received 13 applications through the NIHR Site Identification service from GP and R&D and Dermatology departments of the Hospitals. Principal Investigator is based in Bedford Hospital. The duration of the treatment is 14 days and 30 days for the follow-up. The first visit patient is planned for 01/02/2016 and last patient visit is planned for 15/04/2016. But the dates will be adjusted depending on when we receive the ethical approval.
  Eligibility:
  Ages eligible for study: Patients from 3 – to 70 years
  Genders eligible for study: Male and female
  The adults participants will undergo physical examination for scoring the SCORAD and POEM index and the blood test for IgE level. The children will undergo only physical examination for scoring index.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  16/LO/0437

• Date of REC Opinion

  23 Mar 2016

• REC opinion

  Unfavourable Opinion