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出境医 / 临床实验 / A Mediterranean Approach to Low FODMAP Diet (MED-LFD) for Managing IBS Symptoms

A Mediterranean Approach to Low FODMAP Diet (MED-LFD) for Managing IBS Symptoms

Study Description
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.

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

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 Design
Layout table for study information
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
Arms and Interventions
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.

Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
Contacts and Locations

Contacts
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Contact: Arezina N. Kasti 6942917860 ext 6942917860 kastiare@yahoo.gr

Locations
Layout table for location information
Greece
Attikon University General Hospital Recruiting
Athens, Greece, 12462
Contact: Arezina Kasti    2105832565 ext +30    kastiare@yahoo.gr   
Sponsors and Collaborators
Attikon Hospital
Department of Gastroenterology, Central Clinical School, Monash University
Investigators
Layout table for investigator information
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
 (submitted: December 17, 2019)
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
 (submitted: June 24, 2019)
  • Assess quality of life in general pre and post intervention among the 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.
  • Assess quality of life with a specialized questionnaire pre and post intervention among the 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, and 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 and 170. A decrease of 10 points or more is a significant improvement.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 24, 2019)
  • Assess any change of symptoms severity 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.
  • Assess any change of symptoms severity with a specialized questionnaire post intervention. [ 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. The secondary outcome is the measure of the effects of the dietary interventions on the individual symptom items score of IBS-SSS, as well as on the characteristics of the stool habit through the administration of the diaries. Lower scores indicate improvement.
  • Adequate relief of symptoms after the intervention. [ Time Frame: Through study completion, an average of 8 weeks. ]
    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.
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
  • 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).
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Med-LFD
  • 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.
    Intervention: Other: Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS
Publications *
  • Varjú P, Farkas N, Hegyi P, Garami A, Szabó I, Illés A, Solymár M, Vincze Á, Balaskó M, Pár G, Bajor J, Szűcs Á, Huszár O, Pécsi 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.
  • Dalrymple 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. Review. Erratum in: BMJ. 2015;350:h1216.

*   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
 (submitted: December 17, 2019)
108
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2019)
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:

  • 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

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arezina N. Kasti 6942917860 ext 6942917860 kastiare@yahoo.gr
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: After the completion of the study, please contact with the research team for more information.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: After the study is published.
Access Criteria: Not funded research with similar interest.
Responsible Party Arezina Kasti, Attikon Hospital
Study Sponsor  ICMJE Attikon Hospital
Collaborators  ICMJE Department of Gastroenterology, Central Clinical School, Monash University
Investigators  ICMJE
Study Director: Konstantinos Triantafyllou Attikon Hospital
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