DyspepsiaNCT05810168
Traditional Dietary Advice Versus Low FODMAP Diet in Postprandial Functional Dyspepsia
A study testing Dietary modifications in people with Dyspepsia and Functional Gastrointestinal Disorders, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Functional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health impairment. Almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as having the postprandial distress syndrome (PDS) variant. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Dyspepsia, Functional Gastrointestinal Disorders
- What is being tested?
- Dietary modifications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Aug 2023to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Fulfil Rome IV symptoms criteria for postprandial functional dyspepsia
- Normal upper gastrointestinal endoscopy within last 3years
- Online access
- English literate
Who cannot join
- Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease)
- Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)
- Documented H.pylori in the last 3 months
- History of eating disorders
- Body mass index <20
- Current dietary interventions
Show all 12Show fewer
- Current use of opioids or anti-inflammatory drugs
- Severe systemic disease (e.g. cardiac, renal, respiratory) necessitating frequent medical consultations)
- Pregnant
- Diabetes mellitus
- Scleroderma
- Memory impairment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: Randomised Trial of Traditional Dietary Advice Versus a Low FODMAP Diet in Postprandial Functional Dyspepsia
Functional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health impairment. Almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as having the postprandial distress syndrome (PDS) variant. However, studies evaluating dietary modifications in PDS are sparse.
The investigators will perform a randomised trial evaluating traditional dietary advice (TDA) vs. a diet low in fermentable fermentable oligo-, di-, mono- saccharides and polyols (low FODMAP diet) in PDS.
Read more
70 patients with PDS will be randomly assigned TDA or a low FODMAP diet. The TDA group will be recommended to eat small, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre. The low FODMAP diet group will be advised to exclude fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners.
Questionnaires are to be completed during the 6-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Nepean Dyspepsia Quality of Life Index.
The primary endpoint to define clinical response will be evaluated over weeks 4-6 as >0.5-point reduction in the PDS subscale of the LPDS (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating).
- Conditions
- Dyspepsia, Functional Gastrointestinal Disorders
- Being tested
- Dietary modifications
- Medical subject headings
- Dyspepsia, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary modificationsOther
TDA and low FODMAP diet
| Study group | Role | What they receive |
|---|---|---|
| Traditional Dietary Advice | Active comparator | Recommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre Receives: Other: Dietary modifications |
| Low FODMAP diet | Active comparator | FODMAPs are fermentable carbohydrates that increase intestinal water and gas production that, in those with visceral hypersensitivity, induces gastrointestinal symptoms. The low FODMAP diet therefore excludes fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners. Receives: Other: Dietary modifications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of clinical responders between traditional dietary advice vs. a Low FODMAP diet on the leuven postprandial distress scale (LPDS)
The Leuven Postprandial Distress Scale (LPDS) assesses the severity of 8 upper gastrointestinal symptoms scored from 0 (none) to 4 (very severe). A difference of 0.5 from baseline for the cardinal PDS symptoms (average of first 3 questions) will be used as a cut-off to determine clinical response by comparing average pre-treatment scores with the average score during weeks 4-6.
Measured: 6 weeks
Secondary outcomes (6)
Proportion of clinical responders between traditional dietary advice vs. a low FODMAP diet
Self-reported adequate relief of dyspeptic symptoms as a binary answer (yes or no). A responder will be defined if ≥50% adequate relief of dyspeptic symptoms during weeks 4-6
Measured: 6 weeks
Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale
The validated Gastrointestinal Symptom Rating Scale assesses the symptoms of irritable bowel syndrome, depicting problems with satiety, abdominal pain, diarrhoea, constipation and bloating. Higher scores represent greater symptom severity. Change in scores will be compared within- and between- groups.
Measured: 6 weeks
Changes in Napean Dyspepsia-related Quality of Life Index
The Napean Dyspepsia Scale is a validated questionnaire assessing dyspepsia-related quality of life syndrome, with higher scores representing worse quality of life. Change in scores will be compared within- and between- groups
Measured: 6 weeks
Changes in Hospital Anxiety and Depression scale
The Hospital Anxiety and Depression Scale is a validated questionnaire assessing mood, with higher scores representing worse mood. Change in scores will be compared within- and between- groups
Measured: 6 weeks
Changes in Somatic Symptom reporting
The validated patient health questionnaire-12 assess extra-intestinal somatic symptoms, with higher scores representing greater somatic symptom severity. Change in scores will be compared within- and between- groups
Measured: 6 weeks
Changes in nutritional intake
The Comprehensive Nutritional Assessment Questionnaire assesses macronutrient and micronutrient intake, FODMAPs, fibre, starch, glycaemic index/load. Change in scores will be compared within- and between- groups
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start30 Aug 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810168
- Sponsor's protocol ID
- STH20655c
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shiha MG, Buckle RL, Shaw CC, Aziz I. Low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet vs Traditional Dietary Advice in Postprandial Functional Dyspepsia: A Randomized Clinical Trial. Clin Gastroenterol Hepatol. 2026 Jun 15:S1542-3565(26)00440-4. doi: 10.1016/j.cgh.2026.06.006. Online ahead of print.
PubMed 42297316
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Traditional Dietary Advice Versus a Low FODMAP Diet in Postprandial Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT05810168
- Acronym / sponsor ID
- STH20655c
- Conditions
- Dyspepsia, Functional Gastrointestinal Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Functional dyspepsia is common, affecting 7.2% of the global population, and associated with substantial health impairment. Almost 80% of patients with functional dyspepsia report meal-related symptoms and are classified as having the postprandial distress syndrome (PDS) variant. However, studies evaluating dietary modifications in PDS are sparse.
The investigators will perform a randomised trial evaluating traditional dietary advice (TDA) vs. a diet low in fermentable fermentable oligo-, di-, mono- saccharides and polyols (low FODMAP diet) in PDS.
70 patients with PDS will be randomly assigned TDA or a low FODMAP diet. The TDA group will be recommended to eat small, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre. The low FODMAP diet group will be advised to exclude fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners.
Questionnaires are to be completed during the 6-week trial, including self-reported adequate relief of dyspeptic symptoms, and the validated Leuven Postprandial Distress Scale (LPDS), Gastrointestinal Symptom Rating Scale, and Nepean Dyspepsia Quality of Life Index.
The primary endpoint to define clinical response will be evaluated over weeks 4-6 as >0.5-point reduction in the PDS subscale of the LPDS (calculated as the mean scores for early satiety, postprandial fullness, and upper abdominal bloating).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Dietary Advice | Active comparator | Other: Dietary modificationsRecommended to eat smaller, regular meals and reduce the intake of caffeine/alcohol/fizzy drinks, fatty/processed/spicy foods, and fibre |
| Low FODMAP diet | Active comparator | Other: Dietary modificationsFODMAPs are fermentable carbohydrates that increase intestinal water and gas production that, in those with visceral hypersensitivity, induces gastrointestinal symptoms. The low FODMAP diet therefore excludes fermentable carbohydrates, which are present in wheat-based products, many fruits/vegetables, pulses, beans, dairy, and sweeteners. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Fulfil Rome IV symptoms criteria for postprandial functional dyspepsia
- Normal upper gastrointestinal endoscopy within last 3years
- Online access
- English literate
Key exclusion criteria (12 listed)
- Organic gastrointestinal diseases (e.g. inflammatory bowel disease, GI cancer, coeliac disease)
- Major abdominal surgery (except laparoscopy, appendectomy, cholecystectomy)
- Documented H.pylori in the last 3 months
- History of eating disorders
- Body mass index <20
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary modificationsTDA and low FODMAP diet | Other | Low FODMAP diet, Traditional Dietary Advice |
Primary outcome
Proportion of clinical responders between traditional dietary advice vs. a Low FODMAP diet on the leuven postprandial distress scale (LPDS)
Time frame: 6 weeks
The Leuven Postprandial Distress Scale (LPDS) assesses the severity of 8 upper gastrointestinal symptoms scored from 0 (none) to 4 (very severe). A difference of 0.5 from baseline for the cardinal PDS symptoms (average of first 3 questions) will be used as a cut-off to determine clinical response by comparing average pre-treatment scores with the average score during weeks 4-6.
6 secondary outcomes
Proportion of clinical responders between traditional dietary advice vs. a low FODMAP diet
Time frame: 6 weeks
Changes in Gastrointestinal Symptom Rating Irritable Bowel syndrome Scale
Time frame: 6 weeks
Changes in Napean Dyspepsia-related Quality of Life Index
Time frame: 6 weeks
Changes in Hospital Anxiety and Depression scale
Time frame: 6 weeks
Changes in Somatic Symptom reporting
Time frame: 6 weeks
Changes in nutritional intake
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Derived from this study: PubMed 42297316Shiha MG, Buckle RL, Shaw CC, Aziz I. Low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, and Polyols Diet vs Traditional Dietary Advice in Postprandial Functional Dyspepsia: A Randomized Clinical Trial. Clin Gastroenterol Hepatol. 2026 Jun 15:S1542-3565(26)00440-4. doi: 10.1016/j.cgh.2026.06.006. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary modifications in people with Dyspepsia and Functional Gastrointestinal Disorders, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of clinical responders between traditional dietary advice vs. a Low FODMAP diet on the leuven postprandial distress scale (LPDS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05810168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.