Traditional Dietary Advice Versus a Low FODMAP Diet Intake in IBS Patients

NCT ID: NCT02107625

Last Updated: 2015-08-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-01-31

Brief Summary

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The purpose of this study is to to assess if the new diet with a low-FODMAP(Fermented Oligo-, Di-, Monosaccharides And Polyols) -content yields a milder symptom picture in IBS patients compared to traditionally dietary advice in IBS. The study also aim to investigate patients compliance to either dietary advices. Further, the investigators aim to find out if IBS patients with different symptoms are alleviated in different ways, to be able to individualize the dietary advices to result in a more optimal symptom relief in each patient in the future.

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Diet A i.e. Low FODMAP diet

The patients are thoroughly informed verbally and in writing how to eat according to the low FODMAP diet. The diet imply restrictions in carbohydrate intake and the patients need to follow a list with yes/no-foods for 4 weeks.

Group Type EXPERIMENTAL

Diet A i.e. Low FODMAP diet

Intervention Type BEHAVIORAL

Diet B, i.e. Traditional IBS diet

The patients are thoroughly informed verbally and in writing how to eat according to traditional IBS dietary advices. The diet imply adapting to regular dietary habit with meals 6 times a day, no to big meals, to chew food thoroughly, to peel fruits and vegetables, no carbonated beverages, no chewing gum, no soft drinks, no sugar-free candies, or cookies. Reduce spicy foods, coffee, alcohol, onion, pulses, and fatty foods. Keep strictly to the dietary advice for 4 weeks.

Group Type EXPERIMENTAL

Diet B, i.e. Traditional IBS diet

Intervention Type BEHAVIORAL

Interventions

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Diet A i.e. Low FODMAP diet

Intervention Type BEHAVIORAL

Diet B, i.e. Traditional IBS diet

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* IBS diagnosis
* Adult (over 18 years)
* Be able to read/understand/write swedish

Exclusion Criteria

* Severe heart failure
* Severe liver disease
* Severe neurologic disease
* Severe psychological disease
* Severe gastrointestinal disease (i.e. celiac disease, IBD (inflammatory bowel disease) e.g.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Karolinska Institutet

OTHER

Sponsor Role collaborator

Aleris Specialistvård Sabbatsberg

UNKNOWN

Sponsor Role collaborator

Responsible Party

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Hans Törnblom

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans Törnblom, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

References

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Nybacka S, Colomier E, Pall Hreinsson J, Storsrud S, Tack J, Tornblom H, Simren M. Dietary Intake and Quality in Irritable Bowel Syndrome: A Comparative Study With Controls and the Association With Symptom Severity. Am J Gastroenterol. 2024 Nov 27;120(9):2154-2164. doi: 10.14309/ajg.0000000000003249.

Reference Type DERIVED
PMID: 39601420 (View on PubMed)

Nybacka S, Simren M, Storsrud S, Tornblom H, Winkvist A, Lindqvist HM. Changes in serum and urinary metabolomic profile after a dietary intervention in patients with irritable bowel syndrome. PLoS One. 2021 Oct 11;16(10):e0257331. doi: 10.1371/journal.pone.0257331. eCollection 2021.

Reference Type DERIVED
PMID: 34634050 (View on PubMed)

Nybacka S, Storsrud S, Liljebo T, Le Neve B, Tornblom H, Simren M, Winkvist A. Within- and Between-Subject Variation in Dietary Intake of Fermentable Oligo-, Di-, Monosaccharides, and Polyols Among Patients with Irritable Bowel Syndrome. Curr Dev Nutr. 2018 Dec 24;3(2):nzy101. doi: 10.1093/cdn/nzy101. eCollection 2019 Feb.

Reference Type DERIVED
PMID: 30838348 (View on PubMed)

Bennet SMP, Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Ohman L, Simren M. Multivariate modelling of faecal bacterial profiles of patients with IBS predicts responsiveness to a diet low in FODMAPs. Gut. 2018 May;67(5):872-881. doi: 10.1136/gutjnl-2016-313128. Epub 2017 Apr 17.

Reference Type DERIVED
PMID: 28416515 (View on PubMed)

Bohn L, Storsrud S, Liljebo T, Collin L, Lindfors P, Tornblom H, Simren M. Diet low in FODMAPs reduces symptoms of irritable bowel syndrome as well as traditional dietary advice: a randomized controlled trial. Gastroenterology. 2015 Nov;149(6):1399-1407.e2. doi: 10.1053/j.gastro.2015.07.054. Epub 2015 Aug 5.

Reference Type DERIVED
PMID: 26255043 (View on PubMed)

Other Identifiers

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KRIBS1

Identifier Type: -

Identifier Source: org_study_id

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