Irritable Bowel SyndromeNCT04072991
A Study Comparing the Effectiveness and Convenience of Dietary Therapy for Irritable Bowel Syndrome (IBS)
A study testing dietary therapy in people with Irritable Bowel Syndrome, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Irritable bowel syndrome is a functional lower gastrointestinal disorder characterised by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- dietary therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Apr 2019to 30 Nov 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Irritable Bowel syndrome - as defined by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms.This is the contemporary definition as provided by the Rome IV committee.
- Age 18-65 years
- English literate
- Can travel to hospital
- Telephone/internet access
Who cannot join
- Inflammatory bowel disease
- Coeliac disease
- Gastrointestinal cancer
- Previous abdominal surgery
- Scleroderma
- Poorly controlled diabetes
Show all 18Show fewer
- Severe liver disease
- Severe renal disease
- Severe respiratory disease
- Severe cardiac disease
- Severe psychiatric disease
- Memory disorders
- Pregnant
- Current dietary interventions
- Recent/current use of Probiotics
- Recent/current use of Antibiotics
- Recent/current use of Narcotics
- Currently titrated antidepressants (i.e. not on a stable dose)
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: E-C DIBS: Randomised Controlled Study: Comparing the Effectiveness and Convenience of Dietary Therapy for Irritable Bowel Syndrome (IBS)
Irritable bowel syndrome is a functional lower gastrointestinal disorder characterised by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms. Irritable bowel syndrome has a prevalence of approximately 10% in adults, shows a female preponderance, and is more common in younger individuals. In clinical practice, Irritable bowel syndrome accounts for almost a third of all gastroenterology cases seen in primary care, with a subsequent third of these being referred onto secondary-care for further evaluation. The economic burden of Irritable bowel syndrome, in terms of medical expense, work absenteeism and loss of productivity, is considerable.
The exact cause of irritable bowel syndrome is unknown. Accordingly there has been a huge surge in interest for dietary therapies to help manage Irritable bowel syndrome. To date, there are only a handful of small randomized controlled trials evaluating the efficacy of dietary therapy in Irritable bowel syndrome. In light of this we plan to conduct the first randomized controlled trial directly comparing the effectiveness of the low-FODMAP diet, British Dietetic Association diet, and the gluten free diet in Irritable bowel syndrome. Moreover, such a trial allows for a direct comparison of nutritional and gut microbial changes, both of which can suffer detrimental consequences following the implementation of restrictive dietary therapies. This study is also unique in that it takes into consideration the patients' perspective with regards to the convenience and cost-effectiveness of implementing such diets into routine day-to-day life. The study will aim to recruit 100 patients from Sheffield Teaching Hospitals gastrointestinal clinics. Following recruitment patients will be seen by a hospital dietitian where they will be randomized to one of the 3 diets. Participants will complete a questionnaire portfolio weekly for one month as part of the study
- Conditions
- Irritable Bowel Syndrome
- Being tested
- dietary therapy
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary therapyOther
participants will undertake a four week diet as part of their IBS treatment
| Study group | Role | What they receive |
|---|---|---|
| Low FODMAP diet | Active comparator | As part of their treatment for IBS participants may be randomised to a low FODMAP diet Receives: Other: dietary therapy |
| Gluten Free Diet | Active comparator | As part of their treatment for IBS participants may be randomised to a gluten free diet Receives: Other: dietary therapy |
| British Dietetic Association diet | Active comparator | As part of their treatment for IBS participants may be randomised to the BDA diet Receives: Other: dietary therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage with at least 50-point reduction in Irritable bowel syndrome Severity Scoring System questionnaire
A validated questionnaire to assess IBS symptoms and severity. The ranges of this questionnaire are included below:
How severe was your pain? 0 (no pain) -100 (very severe)
how severe is your abdominal (tummy) pain? 0 (no pain) - 100 (very severe)
how severe is your abdominal distention/tightness? 0 (no pain) - 100 (very severe)
How satisfied are you with your bowel habit? 0 (very happy) - 100 (very unhappy)
Please indicate with a cross on the line below how much your irritable bowel syndrome is affecting or interfering with your life in general. 0 (not at all) - 100 (completely)
A higher score on any scale represents a negative outcome.
A ≥ 50-point reduction in IBS-SSS following intervention represents a clinically significant improvement
Measured: Baseline to week 4
Secondary outcomes (7)
Changes in proportion with anxiety and depression
Hospital Anxiety and Depression Scale - is a psychological screening tool to which there are in total 14 items, seven each for depression and anxiety. Each item is rated from 0 (not present) to 3 (maximum), giving a cumulative score for each subscale to range from 0 to 21. A subscale score of ≥11 is used to indicate a clinically significant level of anxiety or depression.
Measured: Baseline to week 4
Changes in somatization
The patient health questionnaire (PHQ)-12 non-GI somatic symptoms scale- The PHQ-12 records bothersome non-GI symptoms over the past month. The twelve symptoms assessed are back pain, limb pain, headaches, chest pain, dizziness, fainting spells, palpitations, breathlessness, menstrual cramps, dyspareunia, insomnia, and lethargy. Subjects were asked to rate how much they had been troubled by these 12 symptoms over the last four weeks as 0 ("not bothered at all"), 1 ("bothered a little"), or 2 ("bothered a lot"). Responses were used to calculate the number of sites reporting somatic symptoms (ranging from 0 to 12) and the somatisation severity score (ranging from 0 to 24), which was categorised as minimal (less than or equal to 3), low (4-7), medium (8-12) and high (≥ 13).
Measured: Baseline to week 4
Changes in IBS-quality of life
The IBS quality of life (IBS-QOL) questionnaire - this consists of 34 questions which are summed and averaged for a total score, in addition to eight subscale scores (Dysphoria, Interference with Activity, Body Image, Health Worries, Food Avoidance, Social Reaction, Sexuality, Social Relationship). Total and subscale scores are transformed to a 0-100 scale. Higher scores indicate better IBS-specific QOL.
Measured: Baseline to week 4
Acceptability of dietary restriction
The acceptability of dietary restriction questionnaire is based on the adapted nutrition related quality of life (QOL) questionnaire. Responses are recorded using a Likert scale, with the responses of agree, neutral and disagree.
Measured: Week 4
Food related quality of life (QOL) questionnaire
The food related QOL questionnaire is a seven-item questionnaire based on the food-related QOL tool (Satisfaction with Food-related Life). Responses are recorded on Likert scale, as either agree, neutral and disagree.
Measured: Week 4
Comprehensive Nutrition Assessment Questionnaire
The Comprehensive Nutrition Assessment Questionnaire is a semi-quantitative food frequency questionnaire, consisting of 297 questions, assessing macronutrient and micronutrient intake, as well as FODMAPs, fibre, starch, glycaemic index and glycaemic load
Measured: Baseline to week 4
Changes in stool dysbiosis index
Participants will provide a stool sample both pre- and post-dietary intervention. Data will be analysed by using the GA-map™ Dysbiosis Test (Genetic Analysis AS, Oslo, Norway). Bacterial profiles will be assigned a dysbiosis index (DI), on a scale from 0 to 5, with a DI score of 2 or lower being classified as being within the non dysbiotic region compared to the normobiotic reference range. A DI score of greater than 2 will be considered to be dysbiotic, with a higher DI number indicating greater dysbiosis from the reference range.
Measured: Baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start18 Apr 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
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 Irritable Bowel SyndromeStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imran Aziz, MD, Principal investigator, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072991
- Sponsor's protocol ID
- STH20655
- Status last verified
- Apr 2023
- First submitted
- 27 Aug 2019
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Publications
Rej A, Sanders DS, Shaw CC, Buckle R, Trott N, Agrawal A, Aziz I. Efficacy and Acceptability of Dietary Therapies in Non-Constipated Irritable Bowel Syndrome: A Randomized Trial of Traditional Dietary Advice, the Low FODMAP Diet, and the Gluten-Free Diet. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2876-2887.e15. doi: 10.1016/j.cgh.2022.02.045. Epub 2022 Feb 28.
PubMed 35240330
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-C DIBS: Randomised Controlled Study: Comparing the Effectiveness and Convenience of Dietary Therapy for Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT04072991
- Acronym / sponsor ID
- STH20655
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 28 Aug 2019 (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.
Irritable bowel syndrome is a functional lower gastrointestinal disorder characterised by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms. Irritable bowel syndrome has a prevalence of approximately 10% in adults, shows a female preponderance, and is more common in younger individuals. In clinical practice, Irritable bowel syndrome accounts for almost a third of all gastroenterology cases seen in primary care, with a subsequent third of these being referred onto secondary-care for further evaluation. The economic burden of Irritable bowel syndrome, in terms of medical expense, work absenteeism and loss of productivity, is considerable.
The exact cause of irritable bowel syndrome is unknown. Accordingly there has been a huge surge in interest for dietary therapies to help manage Irritable bowel syndrome. To date, there are only a handful of small randomized controlled trials evaluating the efficacy of dietary therapy in Irritable bowel syndrome. In light of this we plan to conduct the first randomized controlled trial directly comparing the effectiveness of the low-FODMAP diet, British Dietetic Association diet, and the gluten free diet in Irritable bowel syndrome. Moreover, such a trial allows for a direct comparison of nutritional and gut microbial changes, both of which can suffer detrimental consequences following the implementation of restrictive dietary therapies. This study is also unique in that it takes into consideration the patients' perspective with regards to the convenience and cost-effectiveness of implementing such diets into routine day-to-day life. The study will aim to recruit 100 patients from Sheffield Teaching Hospitals gastrointestinal clinics. Following recruitment patients will be seen by a hospital dietitian where they will be randomized to one of the 3 diets. Participants will complete a questionnaire portfolio weekly for one month as part of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low FODMAP diet | Active comparator | Other: dietary therapyAs part of their treatment for IBS participants may be randomised to a low FODMAP diet |
| Gluten Free Diet | Active comparator | Other: dietary therapyAs part of their treatment for IBS participants may be randomised to a gluten free diet |
| British Dietetic Association diet | Active comparator | Other: dietary therapyAs part of their treatment for IBS participants may be randomised to the BDA diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Irritable Bowel syndrome - as defined by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms.This is the contemporary definition as provided by the Rome IV committee.
- Age 18-65 years
- English literate
- Can travel to hospital
- Telephone/internet access
Key exclusion criteria (18 listed)
- Inflammatory bowel disease
- Coeliac disease
- Gastrointestinal cancer
- Previous abdominal surgery
- Scleroderma
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 therapyparticipants will undertake a four week diet as part of their IBS treatment | Other | British Dietetic Association diet, Gluten Free Diet, Low FODMAP diet |
Primary outcome
Percentage with at least 50-point reduction in Irritable bowel syndrome Severity Scoring System questionnaire
Time frame: Baseline to week 4
A validated questionnaire to assess IBS symptoms and severity. The ranges of this questionnaire are included below: How severe was your pain? 0 (no pain) -100 (very severe) how severe is your abdominal (tummy) pain? 0 (no pain) - 100 (very severe) how severe is your abdominal distention/tightness? 0 (no pain) - 100 (very severe) How satisfied are you with your bowel habit? 0 (very happy) - 100 (very unhappy) Please indicate with a cross on the line below how much your irritable bowel syndrome is affecting or interfering with your life in general. 0 (not at all) - 100 (completely) A higher score on any scale represents a negative outcome. A ≥ 50-point reduction in IBS-SSS following intervention represents a clinically significant improvement
7 secondary outcomes
Changes in proportion with anxiety and depression
Time frame: Baseline to week 4
Changes in somatization
Time frame: Baseline to week 4
Changes in IBS-quality of life
Time frame: Baseline to week 4
Acceptability of dietary restriction
Time frame: Week 4
Food related quality of life (QOL) questionnaire
Time frame: Week 4
Comprehensive Nutrition Assessment Questionnaire
Time frame: Baseline to week 4
Changes in stool dysbiosis index
Time frame: Baseline to week 4
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 12 Apr 2023.
- Derived from this study: PubMed 35240330Rej A, Sanders DS, Shaw CC, Buckle R, Trott N, Agrawal A, Aziz I. Efficacy and Acceptability of Dietary Therapies in Non-Constipated Irritable Bowel Syndrome: A Randomized Trial of Traditional Dietary Advice, the Low FODMAP Diet, and the Gluten-Free Diet. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2876-2887.e15. doi: 10.1016/j.cgh.2022.02.045. Epub 2022 Feb 28.
- Individual participant dataSharing planned: No. IPD will not be shared
Related trials for Irritable Bowel Syndrome
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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.
Imran Aziz, MD principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
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 therapy in people with Irritable Bowel Syndrome, 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 5 inclusion and 18 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 12 Apr 2023. 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?
Percentage with at least 50-point reduction in Irritable bowel syndrome Severity Scoring System questionnaire (time frame: Baseline to week 4). 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 NCT04072991, 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 12 Apr 2023.