EcNO: E. Coli Nissle in Oncology

Sponsor

University of Hohenheim (Other)

Overall Status

Completed

CT.gov ID

NCT02706184

Collaborator

Ardeypharm GmbH (Industry)

Enrollment

Locations

Arms

30.1

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Colorectal Cancer	Drug: E. coli Nissle suspension Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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 Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Common toxicity criteria for diarrhea Version 4.0 [Baseline vs. week 12]

Secondary Outcome Measures

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]
C-reactive protein [Baseline vs. week 12]
Hematocrit [Baseline vs. week 12]
alpha-1-Antitrypsin [Baseline vs. week 12]
Calprotectin [Baseline vs. week 12]
Body cell mass in kg [Baseline vs. week 12]
ECM/BCM-Index [Baseline vs. week 12]
ECM = extracellular mass BCM = body cell mass

Other Outcome Measures

stool water content [Baseline vs. week 12]
stool microbiome analyses [Baseline vs. week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Klinikum Ludwigsburg	Ludwigsburg	Baden-Württemberg	Germany	71640
2	Paracelsus-Krankenhaus Ruit	Ostfildern	Baden-Württemberg	Germany	73760
3	Klinikum am Steinenberg /Ermstalklinik	Reutlingen	Baden-Württemberg	Germany	72764
4	Klinikum Stuttgart	Stuttgart	Baden-Württemberg	Germany	70174
5	Klinikum Stuttgart	Stuttgart	Baden-Württemberg	Germany	70374