A Mediterranean Approach to Low FODMAP Diet (MED-LFD) for Managing IBS Symptoms
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Diarrhea
Study type: Interventional

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. 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.
    

Intervention name(s): Med-LFD; Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS
Intervention type(s): Other; Other
Intervention description(s): 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).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: IBS; Quality of life; FODMAP; Mediterranean Diet; Clinical Nutrition; low FODMAP