MedDataX Logo

Lacto-fermented Sauerkraut in the Treatment of Irritable Bowel Syndrome

NCT ID: NCT02977975

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the present study is to assess the efficacy of traditionally fermented sauerkraut in the treatment of irritable bowel syndrome.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Irritable bowel syndrome The human microbiome Microbiota Gut microbiota Probiotics Sauerkraut

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Raw sauerkraut

75 grams of raw, traditionally produced, lacto-fermented sauerkraut, each day for 6 weeks.

Group Type EXPERIMENTAL

Raw sauerkraut

Intervention Type OTHER

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.

Pasteurized sauerkraut

75 grams of pasteurized sauerkraut, each day for 6 weeks.

Group Type OTHER

Pasteurized sauerkraut

Intervention Type OTHER

Sauerkraut without live bacteria.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Pasteurized sauerkraut

Sauerkraut without live bacteria.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Eirik Garnås

Public Health Nutritionist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Volvat Medisinske Senter, Majorstuen

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016/1130/REK

Identifier Type: -

Identifier Source: org_study_id