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Probiotics in the Treatment of Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Raw, lacto-fermented sauerkraut
Mutaflor
Pasteurized sauerkraut
Placebo capsule
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, The human microbiome, Microbiota, Gut microbiota, Probiotics, Sauerkraut

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Volvat Medisinske Senter, MajorstuenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Raw sauerkraut+Probiotic capsule

Raw sauerkraut+placebo capsule

Pasteurized sauerkraut+Probiotic capsule

Pasteurized sauerkraut+Placebo capsule

Arm Description

75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.

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

75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.

75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks.

Outcomes

Primary Outcome Measures

IBS Symptom Severity Scale (IBS-SSS).

Secondary Outcome Measures

Body weight
Fecal microbiome diversity
16S rRNA gene sequences (prokaryotes)
The Quality of Life Scale (QOLS)

Full Information

First Posted
October 17, 2016
Last Updated
October 31, 2016
Sponsor
University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02953171
Brief Title
Probiotics in the Treatment of Irritable Bowel Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, The human microbiome, Microbiota, Gut microbiota, Probiotics, Sauerkraut

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Raw sauerkraut+Probiotic capsule
Arm Type
Experimental
Arm Description
75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.
Arm Title
Raw sauerkraut+placebo capsule
Arm Type
Experimental
Arm Description
75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks.
Arm Title
Pasteurized sauerkraut+Probiotic capsule
Arm Type
Experimental
Arm Description
75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.
Arm Title
Pasteurized sauerkraut+Placebo capsule
Arm Type
Placebo Comparator
Arm Description
75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Raw, lacto-fermented sauerkraut
Intervention Description
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
Dietary Supplement
Intervention Name(s)
Mutaflor
Intervention Description
The probiotic Escherichia coli Nissle 1917, registered in Germany as the medicinal product Mutaflor, possesses a unique combination of fitness and survival factors.
Intervention Type
Other
Intervention Name(s)
Pasteurized sauerkraut
Intervention Description
Sauerkraut without live bacteria.
Intervention Type
Other
Intervention Name(s)
Placebo capsule
Intervention Description
Capsules without probiotics
Primary Outcome Measure Information:
Title
IBS Symptom Severity Scale (IBS-SSS).
Time Frame
Change from day 0 to day 42
Secondary Outcome Measure Information:
Title
Body weight
Time Frame
Change from day 0 to day 42
Title
Fecal microbiome diversity
Description
16S rRNA gene sequences (prokaryotes)
Time Frame
Change from day 0 to day 42
Title
The Quality of Life Scale (QOLS)
Time Frame
Change from day 0 to day 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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: Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool Exclusion Criteria: Psychiatric disorder Metabolic disease Chronic infection Organic gastrointestinal disorder Pregnancy Breastfeeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eirik Garnås
Phone
45293161
Ext
0047
Email
dzs565@alumni.ku.dk
Facility Information:
Facility Name
Volvat Medisinske Senter, Majorstuen
City
Oslo
ZIP/Postal Code
0370
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peder Sandvold Olsen, MD
Email
studie.ibs@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Probiotics in the Treatment of Irritable Bowel Syndrome

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