E. Coli Nissle in Oncology (EcNO)

May 14, 2018 updated by: University of Hohenheim

Randomized, Placebo Controlled Phase III Trial of a Microbiological Concomitant Therapy/Prevention of Chemotherapeutical Induced Diarrhea (Caused by Inflammation and an Impaired Intestinal Barrier) With E. Coli Nissle 1917 (EcN)-Suspension in Patients With Gastric and Colorectal Cancer

In patients with gastric or colorectal cancers, where a treatment with 5-Fluoruracil in combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is planned, it shall be investigated whether E. coli Nissle suspension has an effect on duration and intensity of chemotherapy induced diarrhea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Chemotherapy is used frequently for treating tumors. For many kinds of tumors, chemotherapy is an effective way of treatment. Besides the desired effects on neoplastic cells, the cytotoxic effects often lead to undesirable effects in other cells. Particularly the epithelial tissue of the gastrointestinal tract is affected, mucositis and diarrhea occur. By loss of water and electrolytes, diarrhea often make delay in chemotherapy necessary. Besides mucositis, a chemotherapy also causes changes in gut microbiota as animal models proof. It is well known, than probiotics shorten diarrhea. So far, the use of probiotics in chemotherapy patients was only investigated in one single study. Severity of diarrhea was reduced compared to placebo. Escherichia coli Nissle 1917 (EcN) is a well investigated probiotic. In cell culture, the supernatant of EcN reduced the noxious effect of 5-Fluoruracil concerning cell toxicity and disruption of barrier function.

Therefore, the aim of this study is whether in patients with gastric or colorectal cancers, where a treatment with 5-Fluoruracil in combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is planned, EcN-Suspension is capable to reduce duration and intensity of chemotherapy induced diarrhea.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
        • Klinikum Ludwigsburg
      • Ostfildern, Baden-Württemberg, Germany, 73760
        • Paracelsus-Krankenhaus Ruit
      • Reutlingen, Baden-Württemberg, Germany, 72764
        • Klinikum am Steinenberg /Ermstalklinik
      • Stuttgart, Baden-Württemberg, Germany, 70174
        • Klinikum Stuttgart
      • Stuttgart, Baden-Württemberg, Germany, 70374
        • Klinikum Stuttgart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female adults
  • patients with gastric or colorectal cancer (stages III or IV), where a treatment with 5-Fluoruracil in combination with other chemotherapeutic remedies (FLO, FOLFOX, FOLFOX-Bev, FOLFIRI) is planned
  • life expectancy of at least the trial duration
  • the first administering of the product under investigation must be able to take place 72 hours before or after the beginning of the chemotherapeutical treatment, ideally at the same time
  • an inclusion into the study is only possible at the beginning of the first chemotherapeutic cycle
  • fertile female patients (aged 49 years or minor, the last menstruation occured in less than two years) have to be either surgically sterilized or use the same highly effective method of contraception for at least three months
  • willingness to refrain from other probiotics or probiotic yoghurts, a systematic change of eating behavior should not be planned
  • sufficient knowledge of german language and sufficient psychological state for being able to answer questionnaires and assessment scales
  • informed written consent

Exclusion Criteria:

  • Participation in other clinical trials (currently or within the last 30 days)
  • intolerance against ingredients of the product under investigation
  • pregnancy or lactation
  • being not able to consume the product under investigation orally
  • antidiarrheal therapy with antibiotics
  • alcohol or drug abuse within the last six months
  • any health condition (including abnormal blood parameters) which refuses a patient from taking part in the study according to the opinion of the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Patients receive E. coli Nissle suspension
Drug: E. coli Nissle suspension
Patients receive E. coli Nissle suspension
Other Names:
  • Mutaflor Suspension®
Placebo Comparator: Control
Patients receive placebo
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Common toxicity criteria for diarrhea Version 4.0
Time Frame: Baseline vs. week 12
Baseline vs. week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life by SF-12 questionnaire
Time Frame: Baseline vs. week 12
Baseline vs. week 12
Quality of life by FACIT-D questionnaire
Time Frame: Baseline vs. week 12
Baseline vs. week 12
stool consistency by Bristol stool scale
Time Frame: Baseline vs. week 12
Baseline vs. week 12
Body mass index in kg/m^2
Time Frame: Baseline vs. week 12
Baseline vs. week 12
Phase angle
Time Frame: Baseline vs. week 12
Baseline vs. week 12
C-reactive protein
Time Frame: Baseline vs. week 12
Baseline vs. week 12
Hematocrit
Time Frame: Baseline vs. week 12
Baseline vs. week 12
alpha-1-Antitrypsin
Time Frame: Baseline vs. week 12
Baseline vs. week 12
Calprotectin
Time Frame: Baseline vs. week 12
Baseline vs. week 12
Body cell mass in kg
Time Frame: Baseline vs. week 12
Baseline vs. week 12
ECM/BCM-Index
Time Frame: Baseline vs. week 12
ECM = extracellular mass BCM = body cell mass
Baseline vs. week 12

Other Outcome Measures

Outcome Measure
Time Frame
stool water content
Time Frame: Baseline vs. week 12
Baseline vs. week 12
stool microbiome analyses
Time Frame: Baseline vs. week 12
Baseline vs. week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hohenheim

Collaborators

Ardeypharm GmbH

Investigators

  • Study Director: Stephan C. Bischoff, Prof., ZKES GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

February 23, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZKES-EcNO-2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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