An interventional study of Traditional dietary advice and low FODMAP content and Low carbohydrate diet in Irritable Bowel Syndrome, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-27.
Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Supportive care
Irritable Bowel Syndrome is a common disease to which there is no curable treatment. Diet is considered to trigger symptoms associated with the clinical picture of IBS, and dietary treatment is thus believed to relieve the symptoms of IBS. As the disease is very heterogeneous in its manifestation, different treatment options might be indicated depending on the predominant symptom. To investigate the response to different dietary treatment options, a randomized controlled intervention trial will be carried out in adult patients (>18 y) with IBS according to Rome IV criteria. The aim of this study is to compare the response to two different dietary treatments or optimized medical treatment.
The study is a randomized controlled trial comparing three different treatments during four weeks:
Combination of low FODMAP diet + traditional dietary advice (based on NICE recommendations)
Diet low in carbohydrates
Pain/discomfort:
Constipation:
Primary endpoint: IBS-SSS reduction >50 points
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's planned enrollment of 300 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Sahlgrenska University Hospital is the lead sponsor of 259 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Low carbohydrate diet
Other: Traditional dietary advice and low FODMAP content
Optimized Medical treatment
Other: Optimized Medical treatment
Traditional dietary advice and low FODMAP content
Other: Low carbohydrate diet
Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.
Diet that contains a maximum of 10 energy percent of carbohydrates, 23 energy % proteins and 67 energy % fat.
Standard consultation by physician and if needed patients will receive medical treatment based on the most prominent symptom. Constipation: osmotic laxatives, linaclotide. Diarrhea: loperamid, bile acid binders. Pain: anti depressent, antispasmodics, linaclotide.
The proportion (%) of patients who respond to treatment
A responder is defined as having an IBS-SSS reduction \>50 points @ 4 weeks
Time frame: Baseline to 4 weeks
Change in symptom severity
Absolute and percentage change in IBS-SSS
Time frame: Baseline, 4 weeks, 3 and 6 months
Determinants for GI symptoms by IBS-SSS
GI symptoms measured by IBS-SSS
Time frame: Baseline, 4 weeks, 3 and 6 months
Determinants for GI symptoms by GSRS-IBS
GI symptoms measured by GSRS-IBS
Time frame: Baseline, 4 weeks, 3 and 6 months
Predictors of response to treatment
Potential predictors include demographics, questionnaire data, microbiota, metabolites, immunology
Time frame: Baseline to 4 weeks
Adherence to allocated intervention
Including compliance to dietary intervention during 4 weeks, and long-term adherence during follow-up
Time frame: Baseline, 4 weeks, 3 and 6 months
Change in microbiota content
Fecal microbiota analysis using 16S technique
Time frame: Baseline, 4 weeks, 6 months
Change in extra-intestinal symptoms and quality of life
As assessed by IBS specific questionnaires
Time frame: Baseline, 4 weeks, 3 and 6 months
Change in metabolic profile
Metabolomics in serum and urine samples
Time frame: Baseline, 4 weeks, 6 months
Qualitative assessment
Patient's subjective experiences related to the dietary intervention described by qualitative methods.
Time frame: Approx. at 3 months follow-up
Plan to share: No
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Sahlgrenska University Hospital