Gastric or colorectal cancers, where a treatment with 5-Fluoruracil and one further chemotherapeutic remedy (either irinotecan or a platinum based chemotherapeutic remedy) is planned.
Conditions
Interventions
Trade Name: Mutaflor® Suspension
Pharmaceutical Form: Oral suspension
Other descriptive name: E. coli Nissle 1917 (concentration unit: cfu = colony forming units)
Concentration unit: CFU/ml colony for
Sponsors
ZKES GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female adults; patients with gastric or colorectal cancer (stages III or IV), where a treatment with 5-Fluoruracil and one further chemotherapeutical remedy (either Irinoecan or a platinum based chemotherapeutical remedy) is planned, the addition of bevacizumab antibody is allowed as well; life expectancy of at least the trial duration; the first administering of the product under investigation must be able to take place 72 hours befor 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 minths; 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 54 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
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; beeing 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study investigates whether a Escherichia coli Nissle-suspenison has a (preventive) antidiarrheal effect in patients with tumors who are treated with chemotherapeutic schemes which are associated with increased occurances of diarrhea. Diarrhea caused by treatment are thought to be reduced in intensity and/or frequency by the treatment with Escherichia coli Nissle-Suspension.;Secondary Objective: not applicable;Primary end point(s): Common toxicity criteria (CTC) for diarrhea ;Timepoint(s) of evaluation of this end point: End of the study (after six chemotherapeutic cycles) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life (according to SF12 and FACIT-D) stool consistency according to the Bristol stool scale anthropometry (Body Mass Index (BMI) bioelectrical impedance analysis (BIA) blood parameters (C-reactive protein, haematocrit) stool parameters (a1-Antitrypsin, Calprotectin);Timepoint(s) of evaluation of this end point: End of the study (after six chemotherapeutic cycles) | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
ZKES GmbH
Outcome results
None listed