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

NCT05124262 | Not Yet Recruiting DMC

• 1 other identifier: GMC-FODMAPgroup
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Keywords

Low FODMAPdiet

Outcome Measures

Primary Outcomes (1)

• Change in IBS Symptom Severity Scores (IBS-SSS)

  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 Outcomes (5)

• Change in Multidimensional Fatigue Inventory (MFI-20)

  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)

  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)

  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)

  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)

  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 Outcomes (6)

• Change in three day food diary measuring FODMAPintake for compliance to diet intervention

  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,

  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

  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.

Study Arms (2)

Low-FODMAPdiet group

EXPERIMENTAL

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

Delayed start of treatment low-FODMAPdiet group

EXPERIMENTAL

Delayed start of treatment. This arm starts after three months

Other: Low- FODMAPdiet group intervention

Interventions

Low- FODMAPdiet group intervention OTHER

Diet intervention

Delayed start of treatment low-FODMAPdiet group; Low-FODMAPdiet group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Aleris Gastromottagningen City: collaborator

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• PerJohan Lindfors, MD, Med. dr

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PerJohan Lindfors, MD, Med. dr

CONTACT

08-128 570 00; perjohan.lindfors@ki.se

Therese Liljebo, PHD- student

CONTACT

08-128 570 00; therese.liljebo@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Operations Manager and Chief Physician

Model Details: Randomized controlled trial with direct or delayed treatment start

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 17, 2021
• Study Start: April 1, 2024
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2026
• Last Updated: February 6, 2024

Record last verified: 2024-02