Ehlers-Danlos syndromes Genetic Diseases
Conditions
Interventions
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 bacte
Sponsors
Symprove Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
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)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality-of-life measured using EQ-5D-5L questionnaire at baseline, week 6, week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal symptoms measured using the Gastrointestinal Symptom Rating Scale (GSRS) at baseline, weeks 6 and 12;Mental health measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, weeks 6 and 12;Patient experience measured using study-specific questions (non-validated) at weeks 6 and 12;Adverse events/side effects measured using patient report on study surveys at weeks 6 and 12 | — |
Countries
England, United Kingdom
Contacts
Public ContactSusan Booth
Outcome results
None listed