Irritable Bowel Syndrome
Conditions
Keywords
Irritable bowel syndrome, The human microbiome, Microbiota, Gut microbiota, Probiotics, Sauerkraut
Brief summary
The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut in the treatment of irritable bowel syndrome.
Detailed description
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.
Interventions
OTHERRaw 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.
Sauerkraut without live bacteria.
Sponsors
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Rome III criteria (Criteria fulfilled for the last 6 months with symptom onset at least 3 months prior to diagnosis): Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with two or more of the following: 1. Improvement with defecation 2. Onset associated with a change in frequency of stool 3. Onset associated with a change in form (appearance) of stool
Exclusion criteria
* Psychiatric disorder * Metabolic disease * Chronic infection * Organic gastrointestinal disorder * Pregnancy * Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS Symptom Severity Scale (IBS-SSS). | Change from day 0 to day 42 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | Change from day 0 to day 42 | — |
| Fecal microbiome diversity | Change from day 0 to day 42 | 16S rRNA gene sequences (prokaryotes) |
| The Quality of Life Scale (QOLS) | Change from day 0 to day 42 | — |
Countries
Norway
Outcome results
None listed