A pilot study exploring the use of Symprove for the management of gastroesophageal reflux symptoms
Gastroesophageal reflux disease; GORD
This will be a 6-week, single-arm pilot study involving one study visit at the research site and six follow-up calls. We will recruit a minimum of 70 participants with Gastro-oesophageal Reflux Disease (GORD) symptoms through a single recruiting site in the UK (Manchester University NHS Foundation Trust). All participants will receive Symprove to take once a day for 6 weeks and will be asked to complete validated questionnaires (RESQ-7 and IBS-SSS) about their symptoms every week for 6 weeks (i.e. baseline, week 1, week 2, week 3, week 4, week 5 and week 6). Eligibility of patients will be assessed based on the inclusion and exclusion criteria. Signed and dated informed consent will be obtained at the research site before any study procedures are undertaken. The study co-ordinator will then complete a request for Symprove on the Symprove website ( www.symprove.com). The product will automatically get shipped within 1-2 working days. At Baseline, all recruited participants will complete 3 questionnaires: 1. A diagnostic questionnaire relevant to the present study 2. RESQ-7 questionnaire to assess 7-day recall of reflux symptoms 3. Irritable Bowel Syndrome severity score (IBS-SSS) questionnaire Data on demographics, weight, height, body mass index (BMI) and medications will also be recorded at the Baseline Visit. During the study, patients will have contact with a member of the research team weekly via telephone for six weeks. During the telephone contact with the study team the patient and research team member will complete the follow up questionnaires (RESQ-7, IBS-SSS). Data on any adverse events, and any rescue medications, or changes in usual anti-reflux medications will also be collected.
1. Referred for and completed oesophageal pH/impedance testing or wireless oesophageal pH testing (Bravo capsule), OFF Proton Pump Inhibitors or Histamine-2 Receptor Antagonist at the Neurogastroenterology Unit at Wythenshawe Hospital. 2. Have had a recent endoscopy or Barium swallow as part of routine care in line with the British Society of Gastroenterology guidelines on oesophageal manometry testing 3. People between 18-65 yrs old 4. Any gender identity or sexual orientation 5. Any race or ethnicity 6. Willing and eligible to provide consent and comply with protocol and product intake
1. Use of products marketed as prebiotics or probiotics within 4 weeks of study entry 2. Systemic antibiotic or antifungal treatment within 4 weeks prior to study entry 3. An unstable dose of Proton Pump Inhibitors or Histamine-2 Receptor Antagonist prior to entry into the study 4. An unstable antidepressant/antipsychotic treatment regimen within 3 months prior to study entry (i.e treatment should be stable for 3 months prior to entry) 5. Severe illness(es) or medical condition(s) including gastrointestinal pathologies: gastrointestinal ulcers, coeliac disease, inflammatory bowel disease, bowel cancer, bowel resection, bariatric surgery 6. Surgical operations in the mouth or gastrointestinal tract within 4 weeks prior to study entry or planned during the study 7. Pregnancy or lactation, or plan to become pregnant during the study 8. Advanced pulmonary, cardiac, liver or renal disease 9. Already taking part in a research study