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

NCT03997708 | Completed

• 1 other identifier: ΕΒΔ435/19-06-2018
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome With Diarrhea

Keywords

IBS; Quality of life; FODMAP; Mediterranean Diet; Clinical Nutrition; low FODMAP

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline, 4 - 8 weeks and 6 months post intervention

• Assessment of general quality of life pre and post intervention between groups

  Baseline, 4 - 8 weeks and 6 months post intervention

• Adequate relief of symptoms after the intervention.

  Once per week

• Assessment of symptoms burden in general pre and post intervention.

  Baseline, 4 - 8 weeks and 6 months post intervention

• Assessment of anxiety and depression disorders pre and post intervention.

  Baseline, 4 - 8 weeks and 6 months post intervention

Study Arms (2)

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.

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.

Other: Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS

Interventions

Med-LFD OTHER

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).

Group A

Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS OTHER

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.

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Attikon Hospital: lead
• Department of Gastroenterology, Central Clinical School, Monash University: collaborator

Study Sites (1)

Attikon University General Hospital

Athens, 12462, Greece

Location

Related Publications (4)

• 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.

  PMID: 28806407 BACKGROUND

• 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. No abstract available.

  PMID: 18325967 BACKGROUND

• Kasti 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.

  PMID: 40362860 DERIVED

• Kasti 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.

  PMID: 38892525 DERIVED

MeSH Terms

Interventions

Health

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Konstantinos Triantafyllou

  Attikon Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Dpt of Clinical Nutrition

Study Record Dates

• First Submitted: June 14, 2019
• First Posted: June 25, 2019
• Study Start: July 1, 2019
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study is published.
• Access Criteria: Not funded research with similar interest.

Locations

GR (1)