Irritable Bowel Syndrome With DiarrheaNCT03997708
A Mediterranean Approach to Low FODMAP Diet (MED-LFD) for Managing IBS Symptoms
A study testing Med-LFD and Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS in people with Irritable Bowel Syndrome With Diarrhea, run by Attikon Hospital at 1 site in Greece.
Trial summary
Irritable Bowel Syndrome (IBS) is a common functional bowel disorder characterized by absence of any organic cause. The vast majority of patients associate their symptoms with specific food consumption, creating the need for developing a new therapeutic approach based on altering the dietary habits. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Med-LFD and Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jul 2019to 3 Apr 2023
- 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
- Fulfillment of the Rome IV criteria for IBS (IBS-D, IBS-M, IBS-U)
- Provision of written informed consent.
- Commitment of availability throughout the study period.
- IBS-SSS > 175
Who cannot join
- Any concomitant disease requiring specialized nutrition (e.g. renal failure, diabetes, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity).
- Pregnancy.
- Breastfeeding.
- IBS-C (Bristol Scale type 1 - 2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mediterranean Diet Adjusted to Low FODMAP Diet (MED-LFD) vs NICE Guidelines for Improving IBS Symptoms: a New Approach for Managing IBS
Irritable Bowel Syndrome (IBS) is a common functional bowel disorder characterized by absence of any organic cause. The vast majority of patients associate their symptoms with specific food consumption, creating the need for developing a new therapeutic approach based on altering the dietary habits. The aim of the study focuses in the comparison of the efficacy of two dietary patterns, the adjusted to the Mediterranean Diet Low FODMAP Diet (MED-LFD) and the nutritional guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS.
Read the detailed description
Irritable Bowel Syndrome (IBS) is a functional bowel disorder. Patients associate their symptoms with specific foods consumption, creating the need for developing a new therapeutic approach based on altering the dietary intake of these patients. Low FODMAP Diet is often used as a first-line treatment based on observations showing that short-chain carbohydrates are not adequately absorbed in the small intestine and exacerbate the symptoms of IBS. Additionally, the Mediterranean diet is a cultural heritage representative of all the countries surrounded by the Mediterranean Sea, described as a diet rich in herbal foods (cereals, fruits, vegetables, legumes, nuts, olives), with olive oil as the main consumption of fats, high to moderate consumption of fish and seafood, moderate consumption of eggs, poultry, dairy products and alcohol and low consumption of red meat. On the other hand, the nutritional recommendations of British National Institute for Health and Care Excellence (NICE) managing IBS were created on the grounds of systematic reviews and are based on dietary and lifestyle modifications about caffeine, alcohol, fizzy drinks, fiber, resistant starch, fruits, sorbitol, oat and linseed consumption, meal patterns, probiotics and physical activity.
The direct aim of the study is to compare the efficacy of two dietary patterns, the MED-LFD and the nutritional recommendations of NICE managing IBS. Efficacy will be assessed based on the severity of symptoms. Additionally, possible improvements in quality of life and relief of symptoms between the two groups will be evaluated. Finally, the collected fecal samples will be used to assess the effect of each intervention on gut microbiota.
The sample was calculated to 108 participants with prespecified statistical power 80%, level of significance α=0.05 and 10% adjustment for non-compliance in each group to detect an increase in the primary outcome measure (standard deviation of outcome=60). The above hypothesis of the means was based in the meta-analysis of Peter Varju, et al. 2017. Patients will be recruited by the Department of Clinical Nutrition, Attikon University General Hospital, where the nutritional intervention will be carried out.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- Med-LFD, Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS
- Keywords
- IBS, Quality of life, FODMAP, Mediterranean Diet, Clinical Nutrition, low FODMAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Med-LFDOther
All participants of this group at phase 1 (elimination phase), will initially follow the Med- LFD (2-6 weeks). At phase 2 (reintroduction phase), patients will gradually reintroduce foods rich in FODMAPs (6-8 weeks) and test their tolerance. At phase 3 (maintenance phase), following the reintroduction of foods rich in FODMAPs, patients will follow an individualized diet based on their personal tolerance (a combination of high and low FODMAPs).
Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBSOther
All participants of this group will be informed to follow a diet based on the nutritional guidelines of the British National Institute for Health and Care Excellence (NICE) for Managing IBS for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | MED-LFD Diet (diet A) for 2 - 6 weeks. After this period there will be a reintroduction phase protocol that will last 6 - 8 weeks. Receives: Other: Med-LFD |
| Group B | Active comparator | Diet according to guidelines from the National Institute for Health and Care Excellent (NICE) Managing IBS (diet B) for 4 weeks. Receives: Other: Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of symptoms severity pre and post intervention using a specialized questionnaire.
IBS- SSS contains 5 specific questions with instructions on how to score them. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from 0 to a maximum score of 100 using a visual analog scale (VAS) with total scores ranging from 0 to 500, with higher scores indicating more severe symptoms. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.
Measured: Baseline, 4 - 8 weeks and 6 months post intervention
Secondary outcomes (6)
Assessment of IBS related quality of life with a specialized questionnaire pre and post intervention between groups.
IBS-QOL - a measure that assesses the degree to which IBS interfered with quality of life over the past 30 days. It is a self-report quality of life measure, which includes domains such as dysphoria, interference with activity, body image, health worry, food avoidance, social relation, sexual and relationship issues. Each of them is rated based on the Likert scale from 1 to 5, the higher the score the lower the quality of life is. The overall score ranges between 34 - 170. A decrease of 10 points or more is a significant improvement.
Measured: Baseline, 4 - 8 weeks and 6 months post intervention
Assessment of general quality of life pre and post intervention between groups
12-Item Short Form Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective, covering the eight domains of health outcomes: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional \& mental health. The items are weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on the questions that range from 0 to 100, with higher score indicating better health.
Measured: Baseline, 4 - 8 weeks and 6 months post intervention
Adequate relief of symptoms after the intervention.
Adequate relief (IBS-AR) is a single item questionnaire of pain and discomfort. It poses the question "Over the past week have you had adequate relief of your IBS symptoms?", with a positive or negative answer. Adequate relief is defined as 50% positive answers within the study period, for the purposes of the trial.
Measured: Once per week
Assessment of symptoms burden in general pre and post intervention.
The GSRS questionnaire was originally developed for dyspeptic patients but was later validated in patients with IBS. The GSRS is a 15-item questionnaire designed to assess common gastrointestinal symptoms. The questionnaire has five subscales, reflux, diarrhea, constipation, indigestion, and abdominal pain, with subscale scores ranging from 1 (no discomfort) to 7 (severe discomfort). Higher scores represent higher symptom burden.
Measured: Baseline, 4 - 8 weeks and 6 months post intervention
Assessment of anxiety and depression disorders pre and post intervention.
The Hospital Anxiety and Depression Scale (HADS) questionnaire is used for the assessment of anxiety and depression symptoms. It's a 14-item scale with seven items for each subscale, anxiety (HADS-A) and depression (HADS-D). Each item is scored on a response scale with four alternatives, ranging between 0 and 3. The total score is the sum of the 14 items, and for each subscale the score is the sum of the respective seven items (ranging from 0-21). A final score of 0-7 on each scale indicates that the patient has no symptoms, a score of 8-10 indicates mild symptoms while a score ≥11 indicates severe symptoms of anxiety and depressive disorders.
Measured: Baseline, 4 - 8 weeks and 6 months post intervention
Evaluation of the effect of interventions on gut microbiota composition between groups.
Fecal samples will be collected from each participant and stored at -80°C.
Measured: Baseline, 2 weeks and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Jul 2019
- Primary completion3 Apr 2023
- Study completion3 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Gastroenterology, Central Clinical School, Monash University
- Responsible party
- Principal investigator, Arezina Kasti, Attikon Hospital
- Investigators
- Konstantinos Triantafyllou, Study director, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997708
- Sponsor's protocol ID
- ΕΒΔ435/19-06-2018
- Status last verified
- Apr 2023
- First submitted
- 14 Jun 2019
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the completion of the study, please contact with the research team for more information.
Publications
Varju P, Farkas N, Hegyi P, Garami A, Szabo I, Illes A, Solymar M, Vincze A, Balasko M, Par G, Bajor J, Szucs A, Huszar O, Pecsi D, Czimmer J. Low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet improves symptoms in adults suffering from irritable bowel syndrome (IBS) compared to standard IBS diet: A meta-analysis of clinical studies. PLoS One. 2017 Aug 14;12(8):e0182942. doi: 10.1371/journal.pone.0182942. eCollection 2017.
PubMed 28806407Dalrymple J, Bullock I. Diagnosis and management of irritable bowel syndrome in adults in primary care: summary of NICE guidance. BMJ. 2008 Mar 8;336(7643):556-8. doi: 10.1136/bmj.39484.712616.AD. No abstract available.
PubMed 18325967Kasti AN, Katsas K, Pavlidis DE, Stylianakis E, Petsis KI, Lambrinou S, Nikolaki MD, Papanikolaou IS, Hatziagelaki E, Papadimitriou K, Kapolos J, Muir JG, Triantafyllou K. Clinical Trial: A Mediterranean Low-FODMAP Diet Alleviates Symptoms of Non-Constipation IBS-Randomized Controlled Study and Volatomics Analysis. Nutrients. 2025 Apr 30;17(9):1545. doi: 10.3390/nu17091545.
PubMed 40362860Kasti AN, Katsas K, Petsis K, Lambrinou S, Synodinou KD, Kapetani A, Smart KL, Nikolaki MD, Halvatsiotis P, Triantafyllou K, Muir JG. Is the Mediterranean Low Fodmap Diet Effective in Managing Irritable Bowel Syndrome Symptoms and Gut Microbiota? An Innovative Research Protocol. Nutrients. 2024 May 23;16(11):1592. doi: 10.3390/nu16111592.
PubMed 38892525
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mediterranean Diet Adjusted to Low FODMAP Diet (MED-LFD) vs NICE Guidelines for Improving IBS Symptoms: a New Approach for Managing IBS
- ClinicalTrials.gov ID
- NCT03997708
- Acronym / sponsor ID
- ΕΒΔ435/19-06-2018
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Keywords
- IBS, Quality of life, FODMAP, Mediterranean Diet, Clinical Nutrition, low FODMAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Collaborators
- Department of Gastroenterology, Central Clinical School, Monash University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 3 Apr 2023 (actual)
- First posted
- 25 Jun 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 (IBS) is a common functional bowel disorder characterized by absence of any organic cause. The vast majority of patients associate their symptoms with specific food consumption, creating the need for developing a new therapeutic approach based on altering the dietary habits. The aim of the study focuses in the comparison of the efficacy of two dietary patterns, the adjusted to the Mediterranean Diet Low FODMAP Diet (MED-LFD) and the nutritional guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS.
Detailed description
Irritable Bowel Syndrome (IBS) is a functional bowel disorder. Patients associate their symptoms with specific foods consumption, creating the need for developing a new therapeutic approach based on altering the dietary intake of these patients. Low FODMAP Diet is often used as a first-line treatment based on observations showing that short-chain carbohydrates are not adequately absorbed in the small intestine and exacerbate the symptoms of IBS. Additionally, the Mediterranean diet is a cultural heritage representative of all the countries surrounded by the Mediterranean Sea, described as a diet rich in herbal foods (cereals, fruits, vegetables, legumes, nuts, olives), with olive oil as the main consumption of fats, high to moderate consumption of fish and seafood, moderate consumption of eggs, poultry, dairy products and alcohol and low consumption of red meat. On the other hand, the nutritional recommendations of British National Institute for Health and Care Excellence (NICE) managing IBS were created on the grounds of systematic reviews and are based on dietary and lifestyle modifications about caffeine, alcohol, fizzy drinks, fiber, resistant starch, fruits, sorbitol, oat and linseed consumption, meal patterns, probiotics and physical activity.
The direct aim of the study is to compare the efficacy of two dietary patterns, the MED-LFD and the nutritional recommendations of NICE managing IBS. Efficacy will be assessed based on the severity of symptoms. Additionally, possible improvements in quality of life and relief of symptoms between the two groups will be evaluated. Finally, the collected fecal samples will be used to assess the effect of each intervention on gut microbiota.
The sample was calculated to 108 participants with prespecified statistical power 80%, level of significance α=0.05 and 10% adjustment for non-compliance in each group to detect an increase in the primary outcome measure (standard deviation of outcome=60). The above hypothesis of the means was based in the meta-analysis of Peter Varju, et al. 2017. Patients will be recruited by the Department of Clinical Nutrition, Attikon University General Hospital, where the nutritional intervention will be carried out.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: Med-LFDMED-LFD Diet (diet A) for 2 - 6 weeks. After this period there will be a reintroduction phase protocol that will last 6 - 8 weeks. |
| Group B | Active comparator | Other: Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBSDiet according to guidelines from the National Institute for Health and Care Excellent (NICE) Managing IBS (diet B) for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Fulfillment of the Rome IV criteria for IBS (IBS-D, IBS-M, IBS-U)
- Provision of written informed consent.
- Commitment of availability throughout the study period.
- IBS-SSS > 175
Key exclusion criteria (4 listed)
- Any concomitant disease requiring specialized nutrition (e.g. renal failure, diabetes, celiac disease, cerebrovascular disease of the central nervous system, major surgical cavity).
- Pregnancy.
- Breastfeeding.
- IBS-C (Bristol Scale type 1 - 2)
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 |
|---|---|---|
| Med-LFDAll participants of this group at phase 1 (elimination phase), will initially follow the Med- LFD (2-6 weeks). At phase 2 (reintroduction phase), patients will gradually reintroduce foods rich in FODMAPs (6-8 weeks) and test their tolerance. At phase 3 (maintenance phase), following the reintroduction of foods rich in FODMAPs, patients will follow an individualized diet based on their personal tolerance (a combination of high and low FODMAPs). | Other | Group A |
| Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBSAll participants of this group will be informed to follow a diet based on the nutritional guidelines of the British National Institute for Health and Care Excellence (NICE) for Managing IBS for 4 weeks. | Other | Group B |
Primary outcome
Change of symptoms severity pre and post intervention using a specialized questionnaire.
Time frame: Baseline, 4 - 8 weeks and 6 months post intervention
IBS- SSS contains 5 specific questions with instructions on how to score them. Each of the five questions (pain severity, pain frequency, abdominal distension severity, bowel movement satisfaction, quality of life) ranges from 0 to a maximum score of 100 using a visual analog scale (VAS) with total scores ranging from 0 to 500, with higher scores indicating more severe symptoms. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.
6 secondary outcomes
Assessment of IBS related quality of life with a specialized questionnaire pre and post intervention between groups.
Time frame: Baseline, 4 - 8 weeks and 6 months post intervention
Assessment of general quality of life pre and post intervention between groups
Time frame: Baseline, 4 - 8 weeks and 6 months post intervention
Adequate relief of symptoms after the intervention.
Time frame: Once per week
Assessment of symptoms burden in general pre and post intervention.
Time frame: Baseline, 4 - 8 weeks and 6 months post intervention
Assessment of anxiety and depression disorders pre and post intervention.
Time frame: Baseline, 4 - 8 weeks and 6 months post intervention
Evaluation of the effect of interventions on gut microbiota composition between groups.
Time frame: Baseline, 2 weeks and 6 months post intervention
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 11 Apr 2023.
- Background: PubMed 28806407Varju P, Farkas N, Hegyi P, Garami A, Szabo I, Illes A, Solymar M, Vincze A, Balasko M, Par G, Bajor J, Szucs A, Huszar O, Pecsi D, Czimmer J. Low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet improves symptoms in adults suffering from irritable bowel syndrome (IBS) compared to standard IBS diet: A meta-analysis of clinical studies. PLoS One. 2017 Aug 14;12(8):e0182942. doi: 10.1371/journal.pone.0182942. eCollection 2017.
- Background: PubMed 18325967Dalrymple J, Bullock I. Diagnosis and management of irritable bowel syndrome in adults in primary care: summary of NICE guidance. BMJ. 2008 Mar 8;336(7643):556-8. doi: 10.1136/bmj.39484.712616.AD. No abstract available.
- Derived from this study: PubMed 40362860Kasti AN, Katsas K, Pavlidis DE, Stylianakis E, Petsis KI, Lambrinou S, Nikolaki MD, Papanikolaou IS, Hatziagelaki E, Papadimitriou K, Kapolos J, Muir JG, Triantafyllou K. Clinical Trial: A Mediterranean Low-FODMAP Diet Alleviates Symptoms of Non-Constipation IBS-Randomized Controlled Study and Volatomics Analysis. Nutrients. 2025 Apr 30;17(9):1545. doi: 10.3390/nu17091545.
- Derived from this study: PubMed 38892525Kasti AN, Katsas K, Petsis K, Lambrinou S, Synodinou KD, Kapetani A, Smart KL, Nikolaki MD, Halvatsiotis P, Triantafyllou K, Muir JG. Is the Mediterranean Low Fodmap Diet Effective in Managing Irritable Bowel Syndrome Symptoms and Gut Microbiota? An Innovative Research Protocol. Nutrients. 2024 May 23;16(11):1592. doi: 10.3390/nu16111592.
- Individual participant dataSharing planned: Yes. After the completion of the study, please contact with the research team for more information.
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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.
Konstantinos Triantafyllou study director
Attikon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Med-LFD and Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS in people with Irritable Bowel Syndrome With Diarrhea, run by Attikon Hospital at 1 site in Greece.
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 4 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 11 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 Greece. 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?
Change of symptoms severity pre and post intervention using a specialized questionnaire. (time frame: Baseline, 4 - 8 weeks and 6 months post intervention). 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 NCT03997708, which also lists 4 linked publications.
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 11 Apr 2023.