A Mediterranean Approach to Low FODMAP Diet (MED-LFD) for Managing IBS Symptoms
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|ClinicalTrials.gov Identifier: NCT03997708|
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : December 18, 2019
|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|
|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|
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.
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.
- 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.
- Assessment of IBS related quality of life with a specialized questionnaire pre and post intervention between groups. [ Time Frame: 6 - 8 weeks ]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.
- Assessment of general quality of life pre and post intervention between groups [ Time Frame: 6 - 8 weeks ]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.
- Adequate relief of symptoms after the intervention. [ Time Frame: Once per week ]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.
- Assessment of symptoms burden any in general pre and post intervention. [ Time Frame: 6 - 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997708
|Contact: Arezina N. Kasti||6942917860 ext email@example.com|
|Attikon University General Hospital||Recruiting|
|Athens, Greece, 12462|
|Contact: Arezina Kasti 2105832565 ext +30 firstname.lastname@example.org|
|Study Director:||Konstantinos Triantafyllou||Attikon Hospital|