Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Clinical Trial to Investigate the Efficacy of Traditionally Fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome|
- IBS Symptom Severity Scale (IBS-SSS). [ Time Frame: Change from day 0 to day 42 ]
- Body weight [ Time Frame: Change from day 0 to day 42 ]
- Fecal microbiome diversity [ Time Frame: Change from day 0 to day 42 ]16S rRNA gene sequences (prokaryotes)
- The Quality of Life Scale (QOLS) [ Time Frame: Change from day 0 to day 42 ]
|Study Start Date:||September 2016|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
Experimental: Raw sauerkraut
75 grams of raw, traditionally produced, lacto-fermented sauerkraut, each day for 6 weeks.
Other: Raw sauerkraut
Sauerkraut fermentations have been shown to contain a broad range of microorganisms, including Leuconostoc mesenteroides, Lactobacillus plantarum, Leuconostoc citreum, Leuconostoc argentinum, Lactobacillus paraplantarum, and Lactobacillus coryniformis. Some of these bacteria, such as Lactobacillus plantarum, are classified as probiotics.
75 grams of pasteurized sauerkraut, each day for 6 weeks.
Other: Pasteurized sauerkraut
Sauerkraut without live bacteria.
Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects around 11% of the population globally. Several factors have been implicated in the pathogenesis of IBS, including psychological stress, gastrointestinal motility, and diet . More recently, it has become clear that the gastrointestinal microbiota may play a critical role in the pathophysiology of this functional GI condition.
Several studies have shown that an altered gut microbiota profile is present in at least some subgroups of IBS patients. This may, in part, explain why a proportion of IBS patients have elevated levels of inflammatory mediators in systemic circulation.
Gut microbiome manipulation, for example through the use of probiotic and prebiotic supplements, has shown some promise in the treatment of IBS. However, the research in this area is still in its infancy, and it remains unclear what type of intervention that is the preferred choice in cases of IBS.
Several studies have investigated how the use of probiotic supplements containing Bifidobacteria and Lactobacilli affect the clinical outcome of patients with IBS. However, to date, no studies have assessed whether fermented vegetables, a "natural" source of probiotic bacteria such as Lactobacillus plantarum, are useful in the treatment of IBS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02977975
|Volvat Medisinske Senter, Majorstuen|
|Oslo, Norway, 0370|