NCT02706184

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3 gastric-cancer

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_3 gastric-cancer

Geographic Reach
1 country

5 active sites

Status
completed

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

July 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 11, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

2.5 years

First QC Date

February 23, 2016

Last Update Submit

May 14, 2018

Conditions

Gastric CancerColorectal Cancer

Keywords

gastric cancercolorectal cancerchemotherapy induced diarrhea5-Fluoruracilchemotherapeutic remedy

Outcome Measures

Primary Outcomes (1)

  • Common toxicity criteria for diarrhea Version 4.0

    Baseline vs. week 12

Secondary Outcomes (11)

  • Quality of life by SF-12 questionnaire

    Baseline vs. week 12

  • Quality of life by FACIT-D questionnaire

    Baseline vs. week 12

  • stool consistency by Bristol stool scale

    Baseline vs. week 12

  • Body mass index in kg/m^2

    Baseline vs. week 12

  • Phase angle

    Baseline vs. week 12

  • +6 more secondary outcomes

Other Outcomes (2)

  • stool water content

    Baseline vs. week 12

  • stool microbiome analyses

    Baseline vs. week 12

Study Arms (2)

Intervention

EXPERIMENTAL

Patients receive E. coli Nissle suspension

Drug: E. coli Nissle suspension

Control

PLACEBO COMPARATOR

Patients receive placebo

Drug: Placebo

Interventions

E. coli Nissle suspensionDRUG

Patients receive E. coli Nissle suspension

Also known as: Mutaflor Suspension®
Intervention
PlaceboDRUG

Placebo

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, 71640, Germany

Location

Paracelsus-Krankenhaus Ruit

Ostfildern, Baden-Wurttemberg, 73760, Germany

Location

Klinikum am Steinenberg /Ermstalklinik

Reutlingen, Baden-Wurttemberg, 72764, Germany

Location

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70174, Germany

Location

Klinikum Stuttgart

Stuttgart, Baden-Wurttemberg, 70374, Germany

Location

MeSH Terms

Conditions

Stomach NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Stephan C. Bischoff, Prof.

    ZKES GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2016

First Posted

March 11, 2016

Study Start

July 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 15, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(5)