NCT02953171

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 2, 2016

Status Verified

October 1, 2016

Enrollment Period

10 months

First QC Date

October 17, 2016

Last Update Submit

October 31, 2016

Conditions

Irritable Bowel Syndrome

Keywords

Irritable Bowel SyndromeThe human microbiomeMicrobiotaGut microbiotaProbioticsSauerkraut

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 (4)

Raw sauerkraut+Probiotic capsule

EXPERIMENTAL

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

Other: Raw, lacto-fermented sauerkrautDietary Supplement: Mutaflor

Raw sauerkraut+placebo capsule

EXPERIMENTAL

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

Other: Raw, lacto-fermented sauerkrautOther: Placebo capsule

Pasteurized sauerkraut+Probiotic capsule

EXPERIMENTAL

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

Dietary Supplement: MutaflorOther: Pasteurized sauerkraut

Pasteurized sauerkraut+Placebo capsule

PLACEBO COMPARATOR

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

Other: Pasteurized sauerkrautOther: Placebo capsule

Interventions

Raw, lacto-fermented sauerkrautOTHER

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.

Raw sauerkraut+Probiotic capsuleRaw sauerkraut+placebo capsule
MutaflorDIETARY_SUPPLEMENT

The probiotic Escherichia coli Nissle 1917, registered in Germany as the medicinal product Mutaflor, possesses a unique combination of fitness and survival factors.

Pasteurized sauerkraut+Probiotic capsuleRaw sauerkraut+Probiotic capsule
Pasteurized sauerkrautOTHER

Sauerkraut without live bacteria.

Pasteurized sauerkraut+Placebo capsulePasteurized sauerkraut+Probiotic capsule
Placebo capsuleOTHER

Capsules without probiotics

Pasteurized sauerkraut+Placebo capsuleRaw sauerkraut+placebo capsule

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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, Oslo County, 0370, Norway

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Airway Resistance

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function TestsDiagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Eirik Garnås

CONTACT

45293161dzs565@alumni.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Public Health Nutritionist

Study Record Dates

First Submitted

October 17, 2016

First Posted

November 2, 2016

Study Start

September 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 2, 2016

Record last verified: 2016-10

Locations

NO(1)