ISRCTN ISRCTN10344823
DOI https://doi.org/10.1186/ISRCTN10344823
Integrated Research Application System (IRAS) 353868
Sponsor Symprove Ltd
Funder Symprove Ltd
Submission date
12/05/2026
Registration date
20/05/2026
Last edited
12/05/2026
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Irritable bowel syndrome (IBS) is a common disorder that affects the digestive system. It's characterised by a range of
symptoms including abdominal pain, bloating, gas, and changes in bowel habits. It is well understood that there is overlap between IBS and mental health issues, such as anxiety and depression.
Probiotics and other food supplements can help relieve IBS symptoms in some patients. Symprove is a multi-strain water-based food supplement containing 4 bacterial strains, which can help stimulate the good bacteria already in the gut. It is already widely available to consumers online and in retail. Symprove has been shown to significantly improve IBS symptoms in previous studies. However, these studies did not assess the impact on mental health.
The aim of this pilot study is to explore the impact of a gut supplement called Symprove on both gut symptoms and mental health symptoms.

Who can participate?
Patients aged 18-75 years with IBS. All participants will be recruited through People for Research (UK).

What does the study involve?
This is a nonrandomised 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 4, 8 and 12 (follow-up). To assess the impact of Symprove, we will compare the follow-up data to the 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 irritable bowel syndrome and help develop new ways to manage it in the future.
A small number of people may experience mild gut disturbances (such as bloating or a 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?
April 2026 to August 2026

Who is funding the study?
Symprove Ltd (UK)

Who is the main contact?
Lauren Hayman, support@peopleforresearch.co.uk

Contact information

Lauren Hayman
Public

People for Research
Suite 302, QC30, Queen Charlotte St
Bristol
BS1 4HJ
United Kingdom

Phone +44 (0)117 9210008
Email support@peopleforresearch.co.uk
Alison Clark
Principal investigator

AC Health and Nutrition Ltd
83 Tattersall Gardens
Southend-on-Sea
SS9 2QS
United Kingdom

Phone +44 (0)7787568279
Email alison@achn.co.uk
Mr Phil Thomas
Scientific

Symprove Ltd
Sands Rd, The Sands
Farnham
GU10 1PX
United Kingdom

Phone +44 (0)1252413600
Email Phil@symprove.com

Study information

Primary study designInterventional
AllocationN/A: single arm study
MaskingOpen (masking not used)
ControlUncontrolled
AssignmentSingle
PurposeSupportive care
Scientific titleA prospective, single-arm, decentralised, real-world evidence pilot study to assess the impact of Symprove in irritable bowel syndrome
Study objectives The aim of this prospective, 12-week real-world study is to explore the effect of Symprove (70 ml per day) on people with IBS. The objective is to understand the impact on gut symptoms, mental health symptoms, broader patient experience and adverse events.
Ethics approval(s)

Approved 18/08/2025, Wales REC 7 (Castlebridge 4, Cardiff, CF11 9AB, United Kingdom; +44 (0)2920230457; Wales.REC7@wales.nhs.uk), ref: 25/WA/0212

Health condition(s) or problem(s) studiedIrritable bowel syndrome (IBS)
InterventionAll 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. Participants will also complete study surveys at weeks 4, 8 and 12. The study does not involve any study visits.
Intervention typeSupplement
Primary outcome measure(s)
  1. IBS symptoms measured using the IBS Symptom Severity Score (IBS-SSS) at baseline and week 12
Key secondary outcome measure(s)
  1. IBS symptoms measured using the IBS Symptom Severity Score (IBS-SSS) at baseline, week 4 and week 8
  2. Mental health measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, week 4, week 8, week 12
  3. Depressive symptoms including somatic measures measured using the Patient Health Questionnaire (PHQ-9) at baseline, week 4, week 8, week 12
  4. Patient experience of taking Symprove measured using study-specific questions (non-validated) at week 4, week 8, week 12
  5. Adverse events/side effects measured using patient report on study surveys at week 4, week 8, week 12
Completion date23/08/2026

Eligibility

Participant type(s)
Age groupMixed
Lower age limit18 Years
Upper age limit75 Years
SexAll
Target sample size at registration150
Key inclusion criteria1. Adults (18-75 years) in the UK who have IBS, either self-diagnosed or medically diagnosed
2. Experiencing regular symptoms related to IBS (e.g., tummy pain, constipation, diarrhoea, bloating)
Key exclusion criteria1. Currently taking probiotics or prebiotics supplements (e.g. Bimuno) or yogurts containing probiotics (e.g., Yakult, Actimel)
3. Taken Symprove in the last 3 months
4. Taken antibiotics in the last 4 weeks
5. Diagnosed with gut conditions other than Irritable Bowel Syndrome, such as inflammatory bowel disease (e.g., Crohn’s disease or ulcerative colitis), coeliac disease, hepatitis, gallstones, acid reflux/dyspepsia
6. Received gastrointestinal surgery, cancer treatment or been hospitalised in the last 6 months
7. Diagnosed with any significant or unstable psychological issues (such as depression, bipolar illness, psychosis)
8. Diagnosed with any significant heart, lung or kidney issues
9. Currently pregnant or breastfeeding
10. Patients taking part in other interventional research where they are receiving treatment
Date of first enrolment29/04/2026
Date of final enrolment31/05/2026

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

People for Research
Suite 302, QC30, Queen Charlotte St
Bristol
BS1 4HJ
England

Results and Publications

Individual participant data (IPD) Intention to shareNo

Editorial Notes

12/05/2026: Study's existence confirmed by Wales REC 7.