CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 108 enrolled
Drug / intervention
Med-LFD +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03997708
NCT03997708N/ACompleted

Mediterranean Diet Adjusted to Low FODMAP Diet (MED-LFD) vs NICE Guidelines for Improving IBS Symptoms: a New Approach for Managing IBS

Attikon Hospital·interventional·Posted Jun 25, 2019·Updated Apr 11, 2023

In Brief

A clinical study evaluating Med-LFD and Nutritional Guidelines of the British National Institute for Health and Care Excellence (NICE) Managing IBS for Irritable Bowel Syndrome With Diarrhea. Completed, enrolled 108 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGreece

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 25, 2019
Enrollment StartJul 1, 2019
Primary CompletionApr 3, 2023
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 7.0 years ago

Interventions

Med-LFDother

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).

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

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.