Impact of Symprove in Ehlers-Danlos Syndrome
| ISRCTN | ISRCTN17931168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17931168 |
| Integrated Research Application System (IRAS) | 364450 |
| Sponsor | Symprove Ltd |
| Funder | Symprove Ltd |
- Submission date
- 26/02/2026
- Registration date
- 26/02/2026
- Last edited
- 10/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Genetic Diseases
Plain English summary of protocol
Background and study aims
The Ehlers-Danlos syndromes (EDS) are a group of 13 heritable connective tissue disorders that affect around 6000
people in the UK. Quality of life in people with EDS can be reduced due to chronic fatigue, joint dislocations and gastrointestinal symptoms. Management of gut symptoms in clinical practice is challenging and generally targeted to
a specific symptom. Gut microbiome-targeted therapies, such as probiotics, have gained attention for their potential
role on the gut microbiome. Gut supplements may be considered a novel strategy for supporting symptom management in people with EDS and warrant further exploration.
The aim of our pilot study is to assess the impact of a food supplement called Symprove on EDS symptoms. Symprove
is a water-based solution that contains billions of live and active bacteria, which can help stimulate the good bacteria already in the gut.
Who can participate?
Patients aged 18-75 years with EDS. All participants will be recruited through Ehlers-Danlos Support UK.
What does the study involve?
This is a non-randomised virtual study which does not involve any study visits. After providing consent to take part
using an online consent form, all participants will receive a 12-week course of Symprove to take once a day.
Participants will also receive a link to complete an online study survey about their symptoms at the beginning of the
study before starting Symprove (baseline) and at weeks 6 and 12 (follow-up). To assess the impact of Symprove we
will compare the follow-up data to baseline.
What are the possible benefits and risks of participating?
Although participants may not receive any health benefit from taking part, research like this can improve our understanding of Ehlers-Danlos Syndrome (EDS) and help develop new ways to manage it in the future. All participants who complete the study will receive a code for an additional free 12-week course of Symprove if they would like to continue after the study. A small number of people may experience mild gut disturbances (such as bloating or change in bowel habit) when they first start taking Symprove. Disturbances will usually resolve in the first few weeks.
Where is the study run from?
Symprove Ltd (UK)
When is the study starting and how long is it expected to run for?
March 2026 to September 2026
Who is funding the study?
Symprove Ltd (UK)
Who is the main contact?
EDS Support UK, research@ehlers-danlos.org
Contact information
Public
EDS Support UK
International House, 45-55 Commercial Street
London
E1 6BD
United Kingdom
| Phone | +44 (0)800 246 1391 |
|---|---|
| research@ehlers-danlos.org |
Scientific
Symprove Ltd
Sands Rd, The Sands
Farnham
GU10 1PX
United Kingdom
| Phone | +44 (0)1252 413600 |
|---|---|
| Phil@symprove.com |
Principal investigator
University College London Hospital
GI physiology unit
Basement EGA building
Grafton Way
London
WC1E 6AS
United Kingdom
| Phone | +44 (0)20 3456 7890 |
|---|---|
| asma.fikree@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | N/A: single arm study |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Supportive care |
| Scientific title | A single-arm, decentralised, real-world evidence pilot study to assess the impact of Symprove in people with Ehlers- Danlos Syndrome (EDS) |
| Study objectives | The aim of this pilot study is to explore the effects of Symprove (70 ml per day) in people with Ehlers-Danlos Syndrome. The objective is to undertake a 12-week single-arm real world evidence study in this population to understand the impact on quality of life, gastrointestinal symptoms, mental health and adverse events. |
| Ethics approval(s) |
Approved 04/02/2026, North West - Preston Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; N/A; preston.rec@hra.nhs.uk), ref: 26/NW/0017 |
| Health condition(s) or problem(s) studied | Ehlers-Danlos syndromes |
| Intervention | All participants will receive a 12-week course of Symprove (70 ml per day), a water-based solution that contains billions of live and active bacteria. The water-based formula makes sure that the bacteria are alive, active and ready to help stimulate the good bacteria already in the gut. After completing a screening questionnaire, an online consent form and a baseline survey, participants will be able to order Symprove using a unique code. Participants will also complete study surveys at weeks 6 and 12. The study does not involve any study visits. |
| Intervention type | Supplement |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 01/09/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Adults (18-75 years) resident in the UK who have either self-diagnosed or received a medical diagnosis of EDS (any subtype) |
| Key exclusion criteria | 1. Currently taking probiotics or prebiotics supplements (e.g. Bimuno) or yogurts containing probiotics (e.g. Yakult, Actimel) 2. Taken Symprove in the last 3 months 3. Taken antibiotics in the last 4 weeks 4. Diagnosed with gut conditions other than DGBIs, such as inflammatory bowel disease (e.g. Crohn’s disease or ulcerative colitis), coeliac disease, hepatitis, gallstones 5. Received gastrointestinal surgery, cancer treatment or been hospitalised in the last 6 months 6. Experiencing any psychological issues (such as depression, bipolar illness, psychosis) that are unstable and/or have recently changed medications for psychological issues 7. Diagnosed with any significant heart, lung or kidney issues 8. Currently pregnant or breastfeeding 9. Patients taking part in other interventional research where they are receiving treatment |
| Date of first enrolment | 09/03/2026 |
| Date of final enrolment | 01/06/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
E1 6BD
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
10/03/2026: The date of first enrolment was changed from 03/03/2026 to 09/03/2026.
26/02/2026: Study's existence confirmed by the North West - Preston Research Ethics Committee.
