Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
A Randomized Controlled Clinical Trial to Investigate the Efficacy of Traditionally Fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome
1 other identifier
interventional
70
1 country
1
Brief Summary
The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut in the treatment of irritable bowel syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 26, 2016
CompletedFirst Posted
Study publicly available on registry
November 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedDecember 19, 2017
December 1, 2017
6 months
November 26, 2016
December 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IBS Symptom Severity Scale (IBS-SSS).
Change from day 0 to day 42
Secondary Outcomes (3)
Body weight
Change from day 0 to day 42
Fecal microbiome diversity
Change from day 0 to day 42
The Quality of Life Scale (QOLS)
Change from day 0 to day 42
Study Arms (2)
Raw sauerkraut
EXPERIMENTAL75 grams of raw, traditionally produced, lacto-fermented sauerkraut, each day for 6 weeks.
Pasteurized sauerkraut
OTHER75 grams of pasteurized sauerkraut, each day for 6 weeks.
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.
Eligibility Criteria
You may qualify if:
- 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:
- Improvement with defecation
- Onset associated with a change in frequency of stool
- Onset associated with a change in form (appearance) of stool
You may not qualify if:
- Psychiatric disorder
- Metabolic disease
- Chronic infection
- Organic gastrointestinal disorder
- Pregnancy
- Breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Volvat Medisinske Senter, Majorstuen
Oslo, 0370, Norway
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Public Health Nutritionist
Study Record Dates
First Submitted
November 26, 2016
First Posted
November 30, 2016
Study Start
September 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
December 19, 2017
Record last verified: 2017-12