Enterosgel® in the treatment of atopic dermatitis in adults
| ISRCTN | ISRCTN12307286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12307286 |
| Secondary identifying numbers | ENT03UK |
- Submission date
- 07/02/2017
- Registration date
- 08/02/2017
- Last edited
- 09/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Stopped
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Skin conditions are the most common reason that people go to their General Practitioner (GP) with a new problem, with around 24% of the population a year consulting their GP with a skin problem. Atopic dermatitis (atopic eczema) is a condition that causes the skin to become itchy, red, dry and cracked. It is one of the most common skin conditions, affecting up to 20% of children and 3% of adults worldwide. Despite currently available effective treatments, there is a need for new treatments which could be safely used as frequent and/or long-term treatments. Intestinal (gut) bacteria may play a role in the development of atopic skin conditions, so treatments targeting the gut could provide a new approach for the prevention and management of these conditions. Intestinal adsorbents, medications which can help normalise the gut bacteria and remove toxins from the gut, are used to treat skin conditions in some countries including Russia and Ukraine. However, more research is needed to demonstrate that intestinal adsorbents can be beneficial in the treatment of skin conditions, at least in certain types of patients. The aim of this study is to assess the effectiveness of an over-the-counter intestinal adsorbent, Enterosgel®, in adult patients with acute dermatitis. The levels of selected substances in the blood (biomarkers) are also measured to investigate their role in dermatitis and to test whether they could be used to predict how patients respond to treatment.
Who can participate?
Patients aged 18 to 60 with acute dermatitis
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in one group receive Enterosgel® in addition to standard-of-care treatment. Participants in the other group receive only standard-of-care treatment. Each patient remains in the study for 28 days and attends two study visits at the medical practice (Days 0 and 14). In addition, a research nurse phones the patients on Days 3, 7, 21 and 28 to ask about symptoms, any adverse events (side effects) and treatment use. The first visit involves a thorough assessment of symptoms by a GP who does not know which group the patient is allocated to at the end of the visit. Patients are also asked to provide a blood sample to measures the levels of biomarkers, and to keep a daily diary about their symptoms and use of treatments until Day 28.
What are the possible benefits and risks of participating?
The researchers cannot promise participants any direct benefit, but participation in the study may provide important information to improve treatments for atopic skin conditions. The procedures performed in this study are used in routine care and do not pose any significant risks. Taking a blood sample can cause some minor discomfort. All medications are standard treatments for atopic dermatitis. Enterosgel® is not currently used for treating dermatitis in the UK, but is available to treat diarrhoea and food poisoning. No adverse reactions to this treatment have been reported. However, research suggests that nausea, vomiting or constipation can occur in very rare instances.
Where is the study run from?
1. The Village Practice (UK)
2. Pickering Medical Practice (UK)
3. Rame Group Practice (UK)
4. Rowen Surgery (UK)
5. Bradford Road Medical Centre (UK)
6. White Horse Health Centre, Westbury Group Practice (UK)
When is the study starting and how long is it expected to run for?
September 2016 to August 2023
Who is funding the study?
Bioline Products s.r.o
Who is the main contact?
1. Mrs Elena Markaryan
2. Dr Preeti Pandya
Contact information
Public
Enteromed Ltd
10 John Street
London
WC1N 4EB
United Kingdom
| Phone | +44 (0)7860 817365 |
|---|---|
| emarkaryan@enteromed.co.uk |
Scientific
The Village Practice
Thornton Medical Centre
Church Road
Thornton-Cleveleys
FY5 2TZ
United Kingdom
| Phone | +44 (0)1253 955561 |
|---|---|
| drpreetipandya@hotmail.com |
Study information
| Study design | 4-week randomised controlled assessor-blinded multi-centre post-marketing efficacy and safety study of a medical device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised, multi-centre study to assess efficacy, tolerability and safety of Enterosgel® in the treatment of acute atopic dermatitis in adults |
| Study objectives | The hypothesis is that the over-the-counter intestinal adsorbent, Enterosgel®, used in combination with standard-of-care treatment results in better clinical outcomes in the treatment of acute atopic dermatitis than standard-of-care treatment alone. |
| Ethics approval(s) | North West - Preston Research Ethics Committee, 03/04/2017, ref: 17/NW/0131 |
| Health condition(s) or problem(s) studied | Atopic dermatitis |
| Intervention | Patients will be randomised in 1:1 ratio using a computer-based randomisation tool (Sealed Envelope Ltd, UK) to: 1. Control group, who will receive standard of care treatment 2. Intervention group, who will receive standard of care treatment together with an intestinal adsorbent, over-the-counter medical device, Enterosgel® (Biotin Products s.r.o, Czech Republic) according to study-specific dosage, i.e. 2 tablespoons and 1 sachet a day for 14 days, and continuing on the same dosage on Days 14-28 if the GP determines on Day 14 that treatment should be continued. Randomisation will be based on the minimisation method where treatment allocation will be stratified by study centre. Each patient will remain in the study for 28 days and attend two study visits at the medical practice (Days 0 and 14). In addition, a research nurse will phone the patients on Days 3, 7, 21 and 28 to ask about symptoms, any adverse events and treatment use. The first visit will involve confirmation of eligibility, taking informed consent and a thorough assessment of symptoms by a GP who will be blinded from the treatment group the patient is randomised to at the end of the visit. Patients will also be asked to provide a blood sample for analyses of biomarkers, and to keep a daily diary about their symptoms and manifestations and use of treatments until Day 28. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Dermatitis severity and symptoms, assessed by a blinded GP using the SCORing Atopic Dermatitis (SCORAD) Score on Day 14 (+/- 2 days) |
| Secondary outcome measures | 1. Patient-reported dermatitis symptoms, measured with the Patient Oriented Eczema Measure (POEM) on Days 3, 7, 14, 21 and 28 (+/- 2 days for all) 2. Percentage of patients with improvement in the SCORAD score from Day 0 to Day 14 (+/- 2 days) 3. Percentage of patients with improvement in the POEM score from Day 0 to Days 3, 7, 14, 21 and 28 (+/- 2 days) 4. Patient-reported duration of individual dermatitis symptoms (n (%) days)* 5. Treatment success, defined as not requiring any treatment for dermatitis on Day 14 (+/- 2 days) 6. Duration of other concomitant symptoms (n (%) days)** 7. Duration of use of standard-of care treatment(s) (n (%) days)** 8. Tolerance and safety of Enterosgel®, assessed via adverse event (AE) reporting from first day of Enterosgel® intake until Day 28 (+/- 2 days) * Symptoms are the same as the symptoms in the POEM questionnaire and will be recorded in a patient diary every day from Day 0 to Day 28 (+/- 2 days). Duration is reported as number of days the symptom lasted calculated based on the last and first day when the symptom was recorded in the questionnaire. Duration will also be reported as % of diary days the symptom was present. ** Other concomitant symptoms and treatment use will be recorded in a patient diary every day from Day 0 to Day 28 (+/- 2 days). Duration is reported as number of days the treatment was used calculated based on the last and first day when the treatment use was recorded in the questionnaire. Duration will also be reported as % of diary days the treatment was used Exploratory outcomes: 1. Correlation between biomarkers (IgE, LPS, TNF-α) and dermatitis severity (SCORAD, POEM) on Day 0 and on Day 14 2. Change in IgE, LPS and TNF-α from Day 0 to Day 14 A +/- 2 day window is allowed for all phone calls/visits |
| Overall study start date | 01/09/2016 |
| Completion date | 30/08/2023 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 44 |
| Key inclusion criteria | 1. Has acute manifestations of dermatitis at the time of screening 2. Has a diagnosis of dermatitis evidenced by a read code (list of read codes provided in the protocol) 3. Aged 18 to 60 4. Able to give informed consent and complete the required study procedures, including providing a blood sample 5. Considered suitable to take part in the study in GP's opinion |
| Key exclusion criteria | 1. History of intestinal atony (severe constipation due to bowel obstruction) 2. Fever (> 39 degrees Celsius) 3. Any other clinically significant skin condition in GP's opinion 4. A history of clinically significant allergic reactions in GP's opinion 5. Use of any clinical trial investigational medication or medical devices within the last 30 days before screening visit 6. Patients with known cancer of any localisation 7. Any underlying condition that could affect the patient’s participation in this study or the results of this study in GP's opinion 8. Pregnancy |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 30/10/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
FY5 2TZ
United Kingdom
YO18 8BL
United Kingdom
PL11 2PD
United Kingdom
SN15 2SB
United Kingdom
BA14 9AR
United Kingdom
BA13 3FQ
United Kingdom
Sponsor information
Industry
10 John Street
London
WC1N 4EB
United Kingdom
"ROR" |
https://ror.org/013bz8f47 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/11/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Study results will be submitted for presentation(s) at dermatology conference(s) and for publication in international peer-reviewed scientific journal(s). |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mrs Elena Markaryan. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/11/2022: The trial has been stopped.
03/11/2021: The recruitment start date was changed from 01/10/2021 to 01/06/2022.
13/04/2021: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/10/2020 to 01/10/2021.
2. The recruitment end date was changed from 30/04/2021 to 30/10/2022.
3. The overall trial end date was changed from 30/08/2022 to 30/08/2023.
4. The intention to publish date was changed from 01/12/2022 to 30/11/2023.
09/07/2020: The trial contact details have been made publicly visible.
28/01/2020: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/09/2019 to 01/10/2020.
2. The recruitment end date was changed from 31/12/2019 to 30/04/2021.
3. The overall trial end date was changed from 30/04/2021 to 30/08/2022.
4. The intention to publish date was changed from 01/06/2020 to 01/12/2022.
22/03/2019: The following changes were made to the trial record:
1. The recruitment start date has been changed from 01/03/2019 to 01/09/2019.
2. The overall trial end date has been changed from 15/04/2018 to 30/04/2021.
08/08/2018: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/09/2017 to 01/03/2019
2. The recruitment end date was changed from 01/03/2018 to 31/12/2019
3. The intention to publish date was changed from 31/12/2018 to 01/06/2020
19/05/2017: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/04/2017 to 01/09/2017.
2. The recruitment end date was changed from 30/09/2017 to 01/03/2018.
3. The overall trial end date was changed from 31/10/2017 to 15/04/2018.
