Exploring Symprove product for the management of gastroesophageal reflux disease (GORD) symptoms
| ISRCTN | ISRCTN21343134 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21343134 |
| Integrated Research Application System (IRAS) | 364448 |
| Central Portfolio Management System (CPMS) | 73875 |
| Sponsor | Manchester University NHS Foundation Trust |
| Funder | Symprove Ltd |
- Submission date
- 19/06/2026
- Registration date
- 29/06/2026
- Last edited
- 15/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Gastro-oesophageal reflux disease (GORD) is a chronic condition where stomach acid frequently flows back into the esophagus, which is the muscular tube that connects the throat to the stomach. This causes symptoms like heartburn, regurgitation, and a sour taste in the mouth. GORD affects 15-20% of the UK population and continues to increase, particularly in younger people. Proton pump inhibitors (PPIs) are prescribed as first-line therapy, but a large proportion of patients with GORD report persistent symptoms. Despite the risks associated with long-term use of PPIs, long-term PPI use is common. More recently, the gut microbiome has been suggested to play a role in GORD. Gut microbiome targeted therapies, such as probiotics, may be therefore considered a novel strategy for GORD symptom management.
The aim of our pilot study is to assess the impact of a gut supplement called Symprove on GORD 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. It has shown efficacy across several clinical groups including irritable bowel syndrome and Parkinson’s disease, as well as vulnerable clinical groups, including children.
Who can participate?
We will recruit 70 participants, aged 18-65, with GORD symptoms through the neurogastroenterology unit at Wythenshawe Hospital.
What does the study involve?
This will be a 6-week non-randomised study, which involves one study visit and six weekly follow-up calls. All participants will receive Symprove delivered to their home to take once a day. Participants will complete two questionnaires (RESQ-7, IBS-SSS) at the Baseline study visit. The same questionnaires will be completed over the phone at each follow-up call. Any adverse events will be recorded throughout the study.
What are the possible benefits and risks of participating?
Although you may not receive any health benefit from taking part, research like this can improve our understanding of GORD 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.
A small number of people may experience mild gut disturbances (such as bloating or change in bowel habit) when they first start taking Symprove. As with any nutritional intervention the gut needs a little time to adapt. Disturbances will usually resolve in the first few weeks.
Where is the study run from?
Manchester University NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
July 2026 to December 2026.
Who is funding the study?
Symprove Ltd.(UK)
Who is the main contact?
Mrs Sorela Mazilu-Wood, sorela.maziluwood@mft.nhs.uk
Contact information
Public, Scientific
Neurogastroenterology Unit, Wythenshawe Hospital, Southmoor Rd
Manchester
M23 9LT
United Kingdom
| Phone | +44 1612914188 |
|---|---|
| sorela.maziluwood@mft.nhs.uk |
Principal investigator
Neurogastroenterology Unit, Wythenshawe Hospital, Southmoor Rd
Manchester
M23 9LT
United Kingdom
 ORCID ID |
0000-0002-2329-0616 |
|---|---|
| Phone | +44 1612912702 |
| Dipesh.vasant@mft.nhs.uk |
Scientific
Neurogastroenterology Unit, Wythenshawe Hospital, Southmoor Rd
Manchester
M23 9LT
United Kingdom
| Phone | +44 1612914293 |
|---|---|
| Sharon.archbold@mft.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Single |
| Purpose | Treatment |
| Participant information sheet | 49754 PIS v 1.2 19May26_.pdf |
| Scientific title | A pilot study exploring the use of Symprove for the management of gastroesophageal reflux symptoms |
| Study objectives | The aim of this study is to evaluate changes in symptoms of GORD following 6 weeks of Symprove treatment in patients with proven pathological gastroesophageal reflux and those with Rome IV Functional Heartburn or Rome IV Reflux hypersensitivity. |
| Ethics approval(s) |
Approved 04/06/2026, North West Greater Manchester (GM) West Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 2071048057; gmwest.rec@hra.nhs.uk), ref: 26/NW/0102 |
| Health condition(s) or problem(s) studied | Gastroesophageal reflux disease; GORD |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 70 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/07/2026 |
| Date of final enrolment | 30/10/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
-
-
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 19/05/2026 | 29/06/2026 | No | Yes | |
| Protocol file | version 1.0 | 11/12/2025 | 15/07/2026 | No | No |
Additional files
- 49754 PIS v 1.2 19May26_.pdf
- Participant information sheet
- ISRCTN21343134 Protocol_+Symprove+GERD+study+V1.0_11Dec2025.pdf
- Protocol file
Editorial Notes
15/07/2026: Uploaded protocol (not peer-reviewed) as an additional file.
03/07/2026: IRAS number added.
19/06/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
