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Dietary Treatment for IBS Within Primary Health Care

NCT ID: NCT05415488

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2025-09-15

Brief Summary

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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

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention study with 2 parallel arms (1:1)
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Online dietary group treatment

Intervention Type OTHER

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

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.

Group Type SHAM_COMPARATOR

Online dietary group treatment

Intervention Type OTHER

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

Interventions

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Online dietary group treatment

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Magnus Simrén

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept of Internal Medicine, Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Sanna Nybacka, PhD

Role: CONTACT

Phone: +46736877771

Email: [email protected]

Other Identifiers

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2022-01624-01

Identifier Type: -

Identifier Source: org_study_id