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| Name | Class |
|---|---|
| Sahlgrenska University Hospital | OTHER |
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Probiotics have become very popular and are by WHO defined as "Live microorganisms which when administered in adequate amounts confer a health benefit on the host". For example, probiotics have been shown to contribute to improvements of abdominal discomfort and intestinal inflammation. The main hypothesis behind the present study is that probiotics influences mucosal regulatory systems, particularly the actions of the hormone Angiotensin II locally in the intestinal mucosa.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSL#3 | Active Comparator |
| |
| Inactive treatment | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSL#3 | Biological | The probiotic product VSL#3® comes in a powder (sachet) that is to be dissolved in half a glass of cold water before ingestion. Two sachets are ingested once daily over 2 weeks. Each dose (sachet) contains 450 billion live (lyophilized) lactic acid bacteria (in defined ratios of the following strains: Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus, Streptococcus thermophilus) and are delivered in a base of maltose and silicon dioxide. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in mucosal expression of components of renin-angiotensin (particularly ACE1, AT1-receptor, AT2-receptor) | Mucosal biopsies from jejunum are sampled via endoscopy immediately before (baseline) and at the end of the 2 weeks treatment period. Protein expressions are assessed by western blotting and the subject acts as its own control. | Change from baseline in protein expressions after 2 weeks of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in epithelial permeability and glucose absorption capacity in vitro | Mucosal biopsies are mounted in modified Ussing chambers. Permeability and glucose-absorption are assessed. | Change from baseline at 2 weeks after start of treatment. |
| Change in intestinal glucose absorption capacity in-vivo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Fändriks, MD, PhD | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept of Gastrosurgical R&E, Sahlgrenska Universityhospital | Gothenburg | SE41345 | Sweden |
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| Placebo | Biological | Two placebo sachets containing maltose and silicon dioxide are given once daily over 2 weeks. |
|
Glucose (75g) with an non-metabolisable analogue (3-O-methyl-glucose; 2g) is instilled into the duodenum via a nasogastroduodenal tube (corresponding to an oral glucose tolerance test). Plasma glucose, 3OMG and insulin are assessed in 15 min periods over 2h. |
| Change from baseline at 2 weeks after start of treatment. |