search
Back to results

Dietary Treatment for IBS Within Primary Health Care (KIPIBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Online dietary group treatment
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Dept of Internal Medicine, Sahlgrenska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

IBS dietary advice according to the NICE guidelines

A healthy diet according to the Swedish dietary guidelines

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of patients with significant symptom reduction
A responder to treatment is defined as having a symptom reduction >50 measured by IBS-SSS

Secondary Outcome Measures

Full Information

First Posted
June 7, 2022
Last Updated
October 24, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
search

1. Study Identification

Unique Protocol Identification Number
NCT05415488
Brief Title
Dietary Treatment for IBS Within Primary Health Care
Acronym
KIPIBS
Official Title
Dietary Treatment for IBS Within Primary Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention study with 2 parallel arms (1:1)
Masking
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.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IBS dietary advice according to the NICE guidelines
Arm Type
Active Comparator
Arm Description
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.
Arm Title
A healthy diet according to the Swedish dietary guidelines
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Online dietary group treatment
Intervention Description
Dietary advice will be given during one 90 minute online group session
Primary Outcome Measure Information:
Title
Proportion of patients with significant symptom reduction
Description
A responder to treatment is defined as having a symptom reduction >50 measured by IBS-SSS
Time Frame
From baseline vs. 6 weeks after group session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanna Nybacka, PhD
Phone
+46736877771
Email
sanna.nybacka@gu.se
Facility Information:
Facility Name
Dept of Internal Medicine, Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magnus Simrén, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Dietary Treatment for IBS Within Primary Health Care

We'll reach out to this number within 24 hrs