---
title: Probiotics in the Treatment of Irritable Bowel Syndrome
nct_id: NCT02953171
overall_status: UNKNOWN
phase: NA
sponsor: University of Copenhagen
study_type: INTERVENTIONAL
primary_condition: Irritable Bowel Syndrome
countries: Norway
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02953171.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02953171"
ct_last_update_post_date: 2016-11-02
last_seen_at: "2026-05-12T06:34:45.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02953171](https://clinicaltrials.gov/study/NCT02953171)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 140
- **Lead Sponsor:** University of Copenhagen
- **Conditions:** Irritable Bowel Syndrome
- **Start Date:** 2016-09
- **Completion Date:** 2017-07
- **CT.gov Last Update:** 2016-11-02

## 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.

## Eligibility

- **Minimum age:** 16 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Raw sauerkraut+Probiotic capsule** (EXPERIMENTAL) — 75 grams of raw, lacto-fermented sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.
- **Raw sauerkraut+placebo capsule** (EXPERIMENTAL) — 75 grams of raw, lacto-fermented sauerkraut + 1 placebo capsule, each day for 6 weeks.
- **Pasteurized sauerkraut+Probiotic capsule** (EXPERIMENTAL) — 75 grams of pasteurized sauerkraut + 1 capsule of the probiotic Mutaflor, each day for 6 weeks.
- **Pasteurized sauerkraut+Placebo capsule** (PLACEBO_COMPARATOR) — 75 grams of pasteurized sauerkraut + 1 placebo capsule, each day for 6 weeks.

## Interventions

- **Raw, lacto-fermented sauerkraut** (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.
- **Mutaflor** (DIETARY_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** (OTHER) — Sauerkraut without live bacteria.
- **Placebo capsule** (OTHER) — Capsules without probiotics

## Primary Outcomes

- **IBS Symptom Severity Scale (IBS-SSS).** _(time frame: Change from day 0 to day 42)_

## Secondary Outcomes

- **Body weight** _(time frame: Change from day 0 to day 42)_
- **Fecal microbiome diversity** _(time frame: Change from day 0 to day 42)_
- **The Quality of Life Scale (QOLS)** _(time frame: Change from day 0 to day 42)_

## Locations (1)

- Volvat Medisinske Senter, Majorstuen, Oslo, Oslo, Norway — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.volvat medisinske senter, majorstuen|oslo|oslo|norway` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02953171*  
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