| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Irritable Bowel Syndrome With Diarrhea | Other: Med-LFD Other: Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS | Not Applicable |
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal 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 adequatetly 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 (mNICE) managing IBS were created on the grounds of systematic reviews and are based on dietary and lifestyle modifications about caffeine, alcohol, fizzy drinks, fibre, 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 mNICE managing IBS. Efficacy will be assessed based on the severity of symptoms. Additionally, possible improvements in quality of life and relief of symptoms post intervention between the two groups will be evaluated.
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 from 59 in the mNICE group to 100 in the MED-LFD group (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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 108 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Mediterranean Diet Adjusted to Low FODMAP Diet (MED-LFD) vs mNICE Guidelines for Improving IBS Symptoms: a New Approach for Managing IBS |
| Actual Study Start Date : | September 1, 2019 |
| Estimated Primary Completion Date : | June 3, 2021 |
| Estimated Study Completion Date : | June 3, 2022 |
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Group A
MED-LFD Diet (diet A) for 2 - 6 weeks. After this period there will be a reintroduction phase protocol that will last 4-6 weeks.
|
Other: Med-LFD
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).
|
|
Active Comparator: Group B
Diet according to guidelines from the National Institute for Health and Care Excellent (mNICE) Managing IBS (diet B) for 14 weeks.
|
Other: Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS
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 8 weeks.
|
| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Arezina N. Kasti | 6942917860 ext 6942917860 | kastiare@yahoo.gr |
| Greece | |
| Attikon University General Hospital | Recruiting |
| Athens, Greece, 12462 | |
| Contact: Arezina Kasti 2105832565 ext +30 kastiare@yahoo.gr | |
| Study Director: | Konstantinos Triantafyllou | Attikon Hospital |
| Tracking Information | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 14, 2019 | ||||||||||||||
| First Posted Date ICMJE | June 25, 2019 | ||||||||||||||
| Last Update Posted Date | December 18, 2019 | ||||||||||||||
| Actual Study Start Date ICMJE | September 1, 2019 | ||||||||||||||
| Estimated Primary Completion Date | June 3, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||
| Current Primary Outcome Measures ICMJE |
Change of symptoms severity pre and post intervention using a specialized questionnaire. [ Time Frame: 6 - 8 weeks ] 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.
|
||||||||||||||
| Original Primary Outcome Measures ICMJE |
|
||||||||||||||
| Change History | |||||||||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
| Descriptive Information | |||||||||||||||
| Brief Title ICMJE | A Mediterranean Approach to Low FODMAP Diet (MED-LFD) for Managing IBS Symptoms | ||||||||||||||
| Official Title ICMJE | Mediterranean Diet Adjusted to Low FODMAP Diet (MED-LFD) vs mNICE Guidelines for Improving IBS Symptoms: a New Approach for Managing IBS | ||||||||||||||
| Brief Summary | Irritable Bowel Syndrome (IBS) is a common functional gastrointestinal 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 (mNICE) Managing IBS. | ||||||||||||||
| Detailed Description |
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal 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 adequatetly 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 (mNICE) managing IBS were created on the grounds of systematic reviews and are based on dietary and lifestyle modifications about caffeine, alcohol, fizzy drinks, fibre, 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 mNICE managing IBS. Efficacy will be assessed based on the severity of symptoms. Additionally, possible improvements in quality of life and relief of symptoms post intervention between the two groups will be evaluated. 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 from 59 in the mNICE group to 100 in the MED-LFD group (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 Type ICMJE | Interventional | ||||||||||||||
| Study Phase ICMJE | Not Applicable | ||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Supportive Care |
||||||||||||||
| Condition ICMJE | Irritable Bowel Syndrome With Diarrhea | ||||||||||||||
| Intervention ICMJE |
|
||||||||||||||
| Study Arms ICMJE |
|
||||||||||||||
| Publications * |
|
||||||||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||||||||
| Recruitment Information | |||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||
| Estimated Enrollment ICMJE |
108 | ||||||||||||||
| Original Estimated Enrollment ICMJE |
180 | ||||||||||||||
| Estimated Study Completion Date ICMJE | June 3, 2022 | ||||||||||||||
| Estimated Primary Completion Date | June 3, 2021 (Final data collection date for primary outcome measure) | ||||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||||||||
| Sex/Gender ICMJE |
|
||||||||||||||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
| Contacts ICMJE |
|
||||||||||||||
| Listed Location Countries ICMJE | Greece | ||||||||||||||
| Removed Location Countries | |||||||||||||||
| Administrative Information | |||||||||||||||
| NCT Number ICMJE | NCT03997708 | ||||||||||||||
| Other Study ID Numbers ICMJE | ΕΒΔ435/19-06-2018 | ||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||
| U.S. FDA-regulated Product |
|
||||||||||||||
| IPD Sharing Statement ICMJE |
|
||||||||||||||
| Responsible Party | Arezina Kasti, Attikon Hospital | ||||||||||||||
| Study Sponsor ICMJE | Attikon Hospital | ||||||||||||||
| Collaborators ICMJE | Department of Gastroenterology, Central Clinical School, Monash University | ||||||||||||||
| Investigators ICMJE |
|
||||||||||||||
| PRS Account | Attikon Hospital | ||||||||||||||
| Verification Date | December 2019 | ||||||||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||||||||