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E. Coli Nissle in Oncology (EcNO)

Primary Purpose

Gastric Cancer, Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
E. coli Nissle suspension
Placebo
Sponsored by
University of Hohenheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer focused on measuring gastric cancer, colorectal cancer, chemotherapy induced diarrhea, 5-Fluoruracil, chemotherapeutic remedy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum Ludwigsburg
  • Paracelsus-Krankenhaus Ruit
  • Klinikum am Steinenberg /Ermstalklinik
  • Klinikum Stuttgart
  • Klinikum Stuttgart

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Patients receive E. coli Nissle suspension

Patients receive placebo

Outcomes

Primary Outcome Measures

Common toxicity criteria for diarrhea Version 4.0

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2016
Last Updated
May 14, 2018
Sponsor
University of Hohenheim
Collaborators
Ardeypharm GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02706184
Brief Title
E. Coli Nissle in Oncology
Acronym
EcNO
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hohenheim
Collaborators
Ardeypharm GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Colorectal Cancer
Keywords
gastric cancer, colorectal cancer, chemotherapy induced diarrhea, 5-Fluoruracil, chemotherapeutic remedy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Patients receive E. coli Nissle suspension
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo
Intervention Type
Drug
Intervention Name(s)
E. coli Nissle suspension
Other Intervention Name(s)
Mutaflor Suspension®
Intervention Description
Patients receive E. coli Nissle suspension
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Common toxicity criteria for diarrhea Version 4.0
Time Frame
Baseline vs. week 12
Secondary Outcome Measure Information:
Title
Quality of life by SF-12 questionnaire
Time Frame
Baseline vs. week 12
Title
Quality of life by FACIT-D questionnaire
Time Frame
Baseline vs. week 12
Title
stool consistency by Bristol stool scale
Time Frame
Baseline vs. week 12
Title
Body mass index in kg/m^2
Time Frame
Baseline vs. week 12
Title
Phase angle
Time Frame
Baseline vs. week 12
Title
C-reactive protein
Time Frame
Baseline vs. week 12
Title
Hematocrit
Time Frame
Baseline vs. week 12
Title
alpha-1-Antitrypsin
Time Frame
Baseline vs. week 12
Title
Calprotectin
Time Frame
Baseline vs. week 12
Title
Body cell mass in kg
Time Frame
Baseline vs. week 12
Title
ECM/BCM-Index
Description
ECM = extracellular mass BCM = body cell mass
Time Frame
Baseline vs. week 12
Other Pre-specified Outcome Measures:
Title
stool water content
Time Frame
Baseline vs. week 12
Title
stool microbiome analyses
Time Frame
Baseline vs. week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephan C. Bischoff, Prof.
Organizational Affiliation
ZKES GmbH
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum Ludwigsburg
City
Ludwigsburg
State/Province
Baden-Württemberg
ZIP/Postal Code
71640
Country
Germany
Facility Name
Paracelsus-Krankenhaus Ruit
City
Ostfildern
State/Province
Baden-Württemberg
ZIP/Postal Code
73760
Country
Germany
Facility Name
Klinikum am Steinenberg /Ermstalklinik
City
Reutlingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72764
Country
Germany
Facility Name
Klinikum Stuttgart
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70174
Country
Germany
Facility Name
Klinikum Stuttgart
City
Stuttgart
State/Province
Baden-Württemberg
ZIP/Postal Code
70374
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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E. Coli Nissle in Oncology

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