Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Probiotics in the Treatment of Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02953171
Recruitment Status : Unknown
Verified October 2016 by Eirik Garnås, University of Copenhagen.
Recruitment status was:  Recruiting
First Posted : November 2, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Eirik Garnås, University of Copenhagen

Brief 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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Raw, lacto-fermented sauerkraut Dietary Supplement: Mutaflor Other: Pasteurized sauerkraut Other: Placebo capsule Not Applicable

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.

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial to Investigate the Efficacy of Lacto-fermented Sauerkraut and the Probiotic E. Coli Nissle 1917 in the Treatment of Irritable Bowel Syndrome
Study Start Date : September 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: Raw sauerkraut+Probiotic capsule
75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.
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.

Experimental: Raw sauerkraut+placebo capsule
75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks.
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.

Other: Placebo capsule
Capsules without probiotics

Experimental: Pasteurized sauerkraut+Probiotic capsule
75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.
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 Comparator: Pasteurized sauerkraut+Placebo capsule
75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks.
Other: Pasteurized sauerkraut
Sauerkraut without live bacteria.

Other: Placebo capsule
Capsules without probiotics




Primary Outcome Measures :
  1. IBS Symptom Severity Scale (IBS-SSS). [ Time Frame: Change from day 0 to day 42 ]

Secondary Outcome Measures :
  1. Body weight [ Time Frame: Change from day 0 to day 42 ]
  2. Fecal microbiome diversity [ Time Frame: Change from day 0 to day 42 ]
    16S rRNA gene sequences (prokaryotes)

  3. The Quality of Life Scale (QOLS) [ Time Frame: Change from day 0 to day 42 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953171


Contacts
Layout table for location contacts
Contact: Eirik Garnås 45293161 ext 0047 dzs565@alumni.ku.dk

Locations
Layout table for location information
Norway
Volvat Medisinske Senter, Majorstuen Recruiting
Oslo, Norway, 0370
Contact: Peder Sandvold Olsen, MD       studie.ibs@gmail.com   
Sponsors and Collaborators
University of Copenhagen

Layout table for additonal information
Responsible Party: Eirik Garnås, Public Health Nutritionist, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02953171     History of Changes
Other Study ID Numbers: 2016/1129/REK
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Eirik Garnås, University of Copenhagen:
Irritable Bowel Syndrome
The human microbiome
Microbiota
Gut microbiota
Probiotics
Sauerkraut
Additional relevant MeSH terms:
Layout table for MeSH terms
Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases