E. Coli Nissle in Oncology

Colorectal Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706184
• Other study ID #: ZKES-EcNO-2015
• Status: Completed
• Phase: Phase 3
• Start date: July 2015
• Est. completion date: January 2018

Study information

• Verified date: May 2018
• Source: University of Hohenheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• E. coli Nissle suspension
Patients receive E. coli Nissle suspension
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Klinikum Ludwigsburg	Ludwigsburg	Baden-Württemberg
Germany	Paracelsus-Krankenhaus Ruit	Ostfildern	Baden-Württemberg
Germany	Klinikum am Steinenberg /Ermstalklinik	Reutlingen	Baden-Württemberg
Germany	Klinikum Stuttgart	Stuttgart	Baden-Württemberg
Germany	Klinikum Stuttgart	Stuttgart	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Hohenheim	Ardeypharm GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	stool water content		Baseline vs. week 12
Other	stool microbiome analyses		Baseline vs. week 12
Primary	Common toxicity criteria for diarrhea Version 4.0		Baseline vs. week 12
Secondary	Quality of life by SF-12 questionnaire		Baseline vs. week 12
Secondary	Quality of life by FACIT-D questionnaire		Baseline vs. week 12
Secondary	stool consistency by Bristol stool scale		Baseline vs. week 12
Secondary	Body mass index in kg/m^2		Baseline vs. week 12
Secondary	Phase angle		Baseline vs. week 12
Secondary	C-reactive protein		Baseline vs. week 12
Secondary	Hematocrit		Baseline vs. week 12
Secondary	alpha-1-Antitrypsin		Baseline vs. week 12
Secondary	Calprotectin		Baseline vs. week 12
Secondary	Body cell mass in kg		Baseline vs. week 12
Secondary	ECM/BCM-Index	ECM = extracellular mass BCM = body cell mass	Baseline vs. week 12