KIPIBS: Dietary Treatment for IBS Within Primary Health Care

Sponsor

Sahlgrenska University Hospital, Sweden (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05415488

Collaborator

(none)

240

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome	Other: Online dietary group treatment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

Dietary Treatment for IBS Within Primary Health Care

Anticipated Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Dec 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IBS dietary advice according to the NICE guidelines 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 Dietary advice will be given during one 90 minute online group session
Sham Comparator: A healthy diet according to the Swedish dietary guidelines 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 Dietary advice will be given during one 90 minute online group session

Arm

Intervention/Treatment

Active Comparator: IBS dietary advice according to the NICE guidelines

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

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

Sham Comparator: A healthy diet according to the Swedish dietary guidelines

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Magnus Simrén, Professor, Sahlgrenska University Hospital, Sweden

ClinicalTrials.gov Identifier:

NCT05415488

Other Study ID Numbers:

2022-01624-01

First Posted:

Jun 13, 2022

Last Update Posted:

Jun 13, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Irritable Bowel Syndrome

Study Results

No Results Posted as of Jun 13, 2022