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NCT05415488 Clinical Trial

Dietary Treatment for IBS Within Primary Health Care

Irritable Bowel Syndrome Clinical Trial

— KIPIBS  

Official title:
Dietary Treatment for IBS Within Primary Health Care

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05415488
Other study ID # 2022-01624-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 15, 2022
Est. completion date September 15, 2025

Study information
Verified date November 2023
Source Sahlgrenska University Hospital, Sweden
Contact Sanna Nybacka, PhD
Phone +46736877771
Email sanna.nybacka@gu.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 240
Est. completion date September 15, 2025
Est. primary completion date September 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Online dietary group treatment
Dietary advice will be given during one 90 minute online group session

Locations
Country Name City State
Sweden Dept of Internal Medicine, Sahlgrenska University Hospital Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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