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Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT02977975
Recruitment Status : Completed
First Posted : November 30, 2016
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Eirik Garnås, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE November 26, 2016
First Posted Date  ICMJE November 30, 2016
Last Update Posted Date December 19, 2017
Study Start Date  ICMJE September 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2016)
IBS Symptom Severity Scale (IBS-SSS). [ Time Frame: Change from day 0 to day 42 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02977975 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2016)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
Official Title  ICMJE A Randomized Controlled Clinical Trial to Investigate the Efficacy of Traditionally Fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Irritable Bowel Syndrome
Intervention  ICMJE
  • 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.
  • Other: Pasteurized sauerkraut
    Sauerkraut without live bacteria.
Study Arms  ICMJE
  • Experimental: Raw sauerkraut
    75 grams of raw, traditionally produced, lacto-fermented sauerkraut, each day for 6 weeks.
    Intervention: Other: Raw sauerkraut
  • Pasteurized sauerkraut
    75 grams of pasteurized sauerkraut, each day for 6 weeks.
    Intervention: Other: Pasteurized sauerkraut
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2017)
70
Original Estimated Enrollment  ICMJE
 (submitted: November 26, 2016)
126
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02977975
Other Study ID Numbers  ICMJE 2016/1130/REK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eirik Garnås, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Copenhagen
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP