This study will investigate the effects of supplementation with two different probiotic products (Lactobacillus reuteri strains) on the intestinal barrier function, gut health and stress symptoms in diarrhoea-predominant irritable bowel syndrome (IBS-D) patients.
After having given their written informed consent, subjects will complete screening procedures to evaluate their eligibility for the study (visit 1). Study participants will undergo two baseline visits (visits 2 and 3, 3 weeks apart) to account for individual variations, and will then be randomly assigned to 6-week intake of one of two Lactobacillus reuteri strains, or placebo in a ratio of 1:1:1 (stratified by sex). Participants will attend a study visit three weeks into the intervention (visit 4) and at the end of the intervention (visit 5, week 6). The intestinal permeability will be assessed using a standardized multi-sugar test at visit 2, visit 3, visit 4, and at end of intervention (visit 5). Blood, saliva and faecal samples will be collected at visit 2-5. In addition, gastrointestinal symptoms will be recorded at those visits (using Gastrointestinal symptom rating scale-IBS, GSRS-IBS; IBS severity scoring system, IBS- SSS). Quality of life using the 5Q-5D-5L and Hospital Anxiety and Depression Scale (HADS) scores will also be recorded at those visits. In addition, at visit 3 and visit 5, the IBS-Quality of life (IBS-QoL) and the Perceived Stress Scale (PSS) will be completed. In a daily diary, participants will record stool frequency and consistency from visit 2 until end-of-study visit 5. Dietary habits of the patients will be assessed via a food frequency questionnaire (FFQ) and a 3-day food diary before the intervention (between visit 2 and 3).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
65
5x10\^8 colony forming units (CFU) of each probiotic strain, two capsules per day over six weeks
Similar in shape and taste to intervention capsules but without the probiotic components, two capsules per day over six weeks
Örebro University
Örebro, Örebro County, Sweden
Change in small intestinal permeability after 6 weeks (urinary lactulose/rhamnose ratio, 0-5h)
Difference in small intestinal permeability, measured as the urinary lactulose/rhamnose secretion ratio (0-5h), after a 6-week intervention with the probiotic products compared to the placebo product
Time frame: 6 weeks
Change in small intestinal permeability after 3 weeks (urinary lactulose/rhamnose ratio, 0-5h)
Difference in small intestinal permeability, measured as the urinary lactulose/rhamnose secretion ratio (0-5h), after a 3-week intervention with the probiotic products compared to the placebo product
Time frame: 3 weeks
Change in whole gut permeability after 6 weeks (urinary sucralose/erythritol ratio, 0-24h)
Difference between intervention with the probiotic products compared to the placebo in whole gut permeability, measured as urinary sucralose/erythritol excretion ratio (0-24hrs)
Time frame: 6 weeks
Change in whole gut permeability after 3 weeks (urinary sucralose/erythritol excretion ratio, 0-24h)
Difference between intervention with the probiotic products compared to the placebo in whole gut permeability, measured as urinary sucralose/erythritol excretion ratio (0-24hrs)
Time frame: 3 weeks
Change in colonic permeability after 6 weeks (urinary sucralose/erythritol ratio, 5-24h)
Difference between intervention with the probiotic products compared to the placebo in colonic permeability, measured as urinary sucralose/erythritol ratio (5-24hrs)
Time frame: 6 weeks
Change in colonic permeability after 3 weeks (urinary sucralose/erythritol ratio, 5-24hrs)
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Difference between intervention with the probiotic products compared to the placebo in colonic permeability, measured as urinary sucralose/erythritol ratio (5-24hrs)
Time frame: 3 weeks
Change in gastroduodenal permeability after 6 weeks (urinary sucrose excretion, 0-5hrs)
Difference between intervention with the probiotic products compared to the placebo in gastroduodenal permeability, measured as urinary sucrose excretion (0-5hrs)
Time frame: 6 weeks
Change in gastroduodenal permeability after 3 weeks (urinary sucrose excretion, 0-5hrs)
Difference between intervention with the probiotic products compared to the placebo in gastroduodenal permeability, measured as urinary sucrose excretion (0-5hrs)
Time frame: 3 weeks
Change in inflammatory status after 3 weeks
Difference between intervention with the probiotic products compared to the placebo in inflammatory markers in blood (e.g. high-sensitive C-reactive protein)
Time frame: 3 weeks
Change in inflammatory status after 6 weeks
Difference between intervention with the probiotic products compared to the placebo in inflammatory markers in blood (e.g. high-sensitive C-reactive protein)
Time frame: 6 weeks