Dietary Treatment for IBS Within Primary Health Care

Not Applicable

Recruiting

• Conditions: Irritable Bowel Syndrome
• Interventions: Other: Online dietary group treatment

• Registration Number: NCT05415488
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-13
• Study Start: 2022-08-15
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-09-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A healthy diet according to the Swedish dietary guidelines	Online dietary group treatment	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.
IBS dietary advice according to the NICE guidelines	Online dietary group treatment	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with significant symptom reduction	From baseline vs. 6 weeks after group session	A responder to treatment is defined as having a symptom reduction \>50 measured by IBS-SSS

Trial Locations

Locations (1)

Dept of Internal Medicine, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden