Gastroesophageal reflux disease
Conditions
Interventions
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 Diseas
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intensity of reflux symptoms measured using Reflux Symptom Questionnaire, 7 day recall (RESQ-7) at screening & baseline visit, FU wk 1; FU wk 2, FU wk 3, FU wk 3; FU wk 4; FU wk 5 & FU wk 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of irritable bowel syndrome measured using Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) at screening & baseline visit, FU wk 1; FU wk 2, FU wk 3, FU wk 3; FU wk 4; FU wk 5 & FU wk 6 | — |
Countries
England, United Kingdom
Contacts
Public ContactSorela Mazilu-Wood
Outcome results
None listed