Dietary Treatment for IBS Within Primary Health Care

NCT05415488 | Unknown

• 1 other identifier: 2022-01624-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Irritable bowel syndrome (IBS) is a multifaceted disorder where diet plays a pivotal role in symptom generation and management. The traditional dietary advice given to patients in clinical settings are based on the NICE guidelines. Some of the advice included in these guidelines have limited scientific evidence. The aim of this study is to investigate the effectiveness of the traditional dietary advice in IBS, according to the NICE guidelines, within a primary health care setting, where treatment is delivered digitally and in groups of 8-12 individuals. As a sham comparator, one group will receive dietary advice according to the Swedish dietary guidelines regarding healthy eating habits.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with significant symptom reduction

  A responder to treatment is defined as having a symptom reduction \>50 measured by IBS-SSS

  From baseline vs. 6 weeks after group session

Study Arms (2)

IBS dietary advice according to the NICE guidelines

ACTIVE COMPARATOR

The traditional dietary advice according to the NICE guidelines and the systematic reviews performed by the British dietetic association (BDA) include having regular meals and to take time to eat, not to skip meals or eat too much at ones. The diet also limits intake of known trigger foods, such as coffee, alcohol, fizzy drinks, spicy foods, fatty foods etc. People who experience loose stools are recommended to avoid sweeteners (-ol), and people with wind/bloating are recommended to eat soluble fibers such as oats and flaxseeds.

Other: Online dietary group treatment

A healthy diet according to the Swedish dietary guidelines

SHAM COMPARATOR

This diet includes eating 500 grams of vegetables and fruits/day, fish approximately 3 times/week, 70 grams of wholegrain/day and to limit intake of red meat.

Other: Online dietary group treatment

Interventions

Online dietary group treatment OTHER

Dietary advice will be given during one 90 minute online group session

A healthy diet according to the Swedish dietary guidelines; IBS dietary advice according to the NICE guidelines

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with IBS (ROME IV) by physician
• Age 18-50
• Ability to read and understand Swedish
• Signed informed consent

You may not qualify if:

• Received dietary treatment for IBS previously
• Manifestations of other conditions that may explain gastrointestinal symptoms

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sanna Nybacka, PhD

CONTACT

+46736877771; sanna.nybacka@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will only be told that the both diets aim to relieve symptoms of IBS, and that none of the diets are expected to cure the disorder. No specific names of the diets will be given.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Intervention study with 2 parallel arms (1:1)

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 13, 2022
• Study Start: August 15, 2022
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2025
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

SE (1)