Effect of a Low- Fermentable-Oligo-Di- Monosaccharides and Polyols Diet Group Intervention on IBS Symptoms and Fatigue (FODMAPS)

February 3, 2024 updated by: Perjohan Lindfors, Karolinska Institutet

Effect of a Low- Fermentable-Oligo-Di-Monosaccharides and Polyols (FODMAPs) Diet Group Intervention on IBS Symptoms and Fatigue

Irritable bowel disease (IBS) is a functional gastrointestinal disorder that affects 10% of the population. Comorbidities are common and fatigue is the most common extraintestinal complaint in IBS patients. There are no cure for the disease but there are nutrition treatments that can relieve symptoms. The main goal of this randomized controlled trial is to test the hypothesis that low-Fermentable- oligo-di- monosaccharides and polyols (FODMAPs) diet kan decrease gastrointestinal symptoms and improve quality of life and fatigue in patients with IBS.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by stomach pain at least one day a week accompanied by change in stool frequency or appearance. Prevalence of IBS is about 10 % of the population worldwide and more common in women. IBS is divided into different subclasses: diarrhea predominant, (IBS-D), predominant constipation, (IBS-C), mixed bowel habits, (IBS-M). Comorbidities are common and fatigue is the most common extraintestinal complaint among the patients. Patients has severely reduced quality of life, reduced work capacity and the cost are substantial for the patients and the society. IBS can´t be cured but the symptoms can be relieved by pharmacological as well as non-pharmacological treatment as psychological- and nutritional treatment. The main goal of this randomized controlled trial is to test the hypothesis that low FODMAPdiet kan decrease gastrointestinal symptoms and improve quality of life and fatigue in patients with IBS.

FODMAPs is an acronym for Fermentable-Oligo-Di-Monosaccharides and Polyols. FODMAPs are carbohydrates that can't be absorbed/splinted in the large intestine and they ferment rapidly and exacerbate gastrointestinal symptoms as flatulence, pain, bloating and loose stools. In total 120 patients with IBS-D and IBS-M will be randomized to immediate treatment start or delayed treatment start. The treatment will be performed in clinical setting, led by a dietitian and in group format including 12 patients in each group. The intervention time is 12 weeks with 5 group visits at a gastroenterology unit. The low-FODMAP treatment is divided into three steps: elimination of FODMAPs, re-introduction and personalization of the diet. Compliance to the diet will be measured by monitoring the FODMAP intake from three day food diaries and a compliance form. Questionnaires will be self reported in a web based application. Food diaries and the stomach diary will be filled out at baseline, at week 5, 12 and 6, 12 and 24 months post intervention.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Established IBS-D by RomeIV- criteria
  • Established IBS-M by RomeIV- criteria
  • Body Mass Index (BMI)18-35

Exclusion criteria:

  • Pregnancy
  • Lactation
  • Ongoing eating disorder/ contact with eating disorder unit
  • Postoperative gastrointestinal surgery that may impact on the gastrointestinal function
  • Celiac disease
  • Psychiatric disorder
  • Other disorder that may impact the possibility to participate in group treatment
  • Diabetes
  • Ongoing low- FODMAPdiet treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low-FODMAPdiet group
Low-FODMAPdiet intervention as group treatment in three steps during 12 weeks, elimination, re-introduction and personalization of the diet. This group of participants starts immediate.
Other: Low- FODMAPdiet group intervention
Diet intervention
Experimental: Delayed start of treatment low-FODMAPdiet group
Delayed start of treatment. This arm starts after three months
Other: Low- FODMAPdiet group intervention
Diet intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in IBS Symptom Severity Scores (IBS-SSS)
Time Frame: Change in baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and 2 years and three months. Within each patient.
Visual Analogues Scale (VAS-scale), composite score measuring bloating, bowel habits, satisfaction with with bowel habits and how IBS impact on QOL. Minimum score 0 and maximum score 500, higher scores indicates more severe disease
Change in baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and 2 years and three months. Within each patient.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Multidimensional Fatigue Inventory (MFI-20)
Time Frame: Between baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and at 2 years and three months. Within each patient.
The Multidimensional Fatigue Inventory-20 (MFI-20) assesses 5 dimensions of fatigue, the severity of general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. Each dimension contain 4 questions. In total 20 questions. Minimum score 0 and maximum score 100. A higher score indicate more severe fatigue.
Between baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and at 2 years and three months. Within each patient.
Change in the gastrointestinal symptom rating scale (GSRS-IBS)
Time Frame: Between baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and at 2 years and three months. Within each patient.
Measuring gastrointestinal symptom severity. Contains 13 questions. Minimum score 13 and maximum score 91. Higher score indicate more severe gastrointestinal symptoms.
Between baseline week 0 and after elimination at week 5, after intervention at week 12, at week 38 and at 1 year and 3 months and at 2 years and three months. Within each patient.
Change in Visceral sensitivity index (VSI)
Time Frame: Baseline week 0 and after intervention at 12 weeks and at week 38 and at 1 year and 3 months and 2 years and three months. Within each patient.
The VSI questionnaire measures GI-specific anxiety, and it includes the cognitive, affective, and behavioral response to fear of GI symptoms, and the context in which these occurs. The questionnaire contains 15 questions. Minimum score 0 and maximum score 75. A higher score indicates a more severe gastrointestinal anxiety.
Baseline week 0 and after intervention at 12 weeks and at week 38 and at 1 year and 3 months and 2 years and three months. Within each patient.
Change in Sickness behaviour (SQ)
Time Frame: Baseline week 0 after intervention at 12 weeks and at week 38, at 1 year and 3 months and 2 years and three months. Within each patient.
Measuring symptoms that occur after acute or chronic inflammation/ infection ie. malaise, listlessness, inability to concentrate, depressed mood and lack of interest in food and surroundings. The form contains 10 questions. Minimum score 0 and maximum score 30. Higher score indicates more severe sickness behaviour.
Baseline week 0 after intervention at 12 weeks and at week 38, at 1 year and 3 months and 2 years and three months. Within each patient.
Change in World Health Organisation (WHO) Disability Assessment Schedule (WHODAS 2.0)
Time Frame: Baseline week 0 and at 12 weeks and at week 38, at 1 year and 3 months and 2 years and three months. Within each patient.
Measuring difficulties due to state of health. 12 questions. Minimum score is 12 and maximum score is 48. Higher score indicates more severe difficulties due to state.
Baseline week 0 and at 12 weeks and at week 38, at 1 year and 3 months and 2 years and three months. Within each patient.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in three day food diary measuring FODMAPintake for compliance to diet intervention
Time Frame: Baseline week 0, after intervention at 12 weeks and at 38 weeks, at 1 year and three months at 2 years and three months.. Within each patient.
Patient report food intake during three days. Two weekdays and one saturday or sunday.
Baseline week 0, after intervention at 12 weeks and at 38 weeks, at 1 year and three months at 2 years and three months.. Within each patient.
Change in meal pattern stomach diary 7 days,
Time Frame: Baseline week 0, after intervention at 12 weeks and at 38 weeks, at 1 year and three months and at 2 years and three months. Within each patient.
Measuring meal pattern
Baseline week 0, after intervention at 12 weeks and at 38 weeks, at 1 year and three months and at 2 years and three months. Within each patient.
Change in stool pattern stomach diary 7 days
Time Frame: Baseline week 0, after intervention at 12 weeks and at 38 weeks, at 1 year and three months and at 2 years and three months. Within each patient.
Measuring stool pattern
Baseline week 0, after intervention at 12 weeks and at 38 weeks, at 1 year and three months and at 2 years and three months. Within each patient.
Change in compliance to FODMAP intervention and level of introduction of FODMAPs
Time Frame: Postintervention at 12 weeks and at 38 weeks, 1 year and three months and at 2 years and three months. Within each patient.
Patients selfreport if they have reintroduced the different FODMAPs ie. fructose, lactose, fructan, galactooligosaccharides and polyols.
Postintervention at 12 weeks and at 38 weeks, 1 year and three months and at 2 years and three months. Within each patient.
Change in Generalized Anxiety disorder (GAD-7)
Time Frame: Baseline week 0 and after 1 year and three months. Within each patient.
Measuring anxiety in total 7 questions added with questions about how the anxiety impacts your life. Minimum score 7 and maximum score 28. Higher score indicate more severe anxiety.
Baseline week 0 and after 1 year and three months. Within each patient.
Change in Patients Health questionnaire (PHQ-9)
Time Frame: Baseline week 0 and at 1 year and three months. Within each patient.
Screening for depressive symptoms. 9 questions. Minimum score 0 and maximum score 27.
Baseline week 0 and at 1 year and three months. Within each patient.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Aleris Gastromottagningen City

Investigators

  • Principal Investigator: PerJohan Lindfors, MD, Med. dr, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

March 15, 2025

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 16, 2021

First Posted (Actual)

November 17, 2021

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMC-FODMAPgroup

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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