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 two different probiotic products, lacto-fermented sauerkraut and the supplement Mutaflor, 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. 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. Many, if not most, probiotic supplements on the market today contain bacteria that are incapable of colonizing the human gut, which may partly explain why the health effects associated with the use of probiotics tend to be temporary, rather than permanent. 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, are useful in the treatment of IBS. Moreover, little is known about how other types of probiotic bacteria, such as those belonging to the genus Escherichia, affect symptoms of IBS.
Interventions
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.
The probiotic Escherichia coli Nissle 1917, registered in Germany as the medicinal product Mutaflor, possesses a unique combination of fitness and survival factors.
Sauerkraut without live bacteria.
Capsules without probiotics
Sponsors
Study design
Eligibility
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