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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02953171
Other study ID # 2016/1129/REK
Secondary ID
Status Recruiting
Phase N/A
First received October 17, 2016
Last updated October 31, 2016
Start date September 2016
Est. completion date July 2017

Study information

Verified date October 2016
Source University of Copenhagen
Contact Eirik Garnås
Phone 45293161
Email dzs565@alumni.ku.dk
Is FDA regulated No
Health authority Norway: Regional Ethics Commitee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 65 Years
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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Raw, lacto-fermented 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.
Dietary Supplement:
Mutaflor
The probiotic Escherichia coli Nissle 1917, registered in Germany as the medicinal product Mutaflor, possesses a unique combination of fitness and survival factors.
Other:
Pasteurized sauerkraut
Sauerkraut without live bacteria.
Placebo capsule
Capsules without probiotics

Locations

Country Name City State
Norway Volvat Medisinske Senter, Majorstuen Oslo

Sponsors (1)

Lead Sponsor Collaborator
University of Copenhagen

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary IBS Symptom Severity Scale (IBS-SSS). Change from day 0 to day 42 No
Secondary Body weight Change from day 0 to day 42 No
Secondary Fecal microbiome diversity 16S rRNA gene sequences (prokaryotes) Change from day 0 to day 42 No
Secondary The Quality of Life Scale (QOLS) Change from day 0 to day 42 No
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