Gastric CancerPhase 3EcNONCT02706184
E. Coli Nissle in Oncology
A Phase 3 study testing E. coli Nissle suspension in people with Gastric Cancer and Colorectal Cancer, run by University of Hohenheim at 5 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Colorectal Cancer
- What is being tested?
- E. coli Nissle suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 5 sitesGermany
- Study dates
- Jul 2015to Jan 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, 71640
Paracelsus-Krankenhaus Ruit
Ostfildern, Baden-Wurttemberg, 73760
Klinikum am Steinenberg /Ermstalklinik
Reutlingen, Baden-Wurttemberg, 72764
Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, 70174
Klinikum Stuttgart
Stuttgart, Baden-Wurttemberg, 70374
About this study
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
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.
Read the 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.
- Conditions
- Gastric Cancer, Colorectal Cancer
- Being tested
- E. coli Nissle suspension, Placebo
- Keywords
- gastric cancer, colorectal cancer, chemotherapy induced diarrhea, 5-Fluoruracil, chemotherapeutic remedy
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E. coli Nissle suspensionDrug
Also called Mutaflor Suspension®
Patients receive E. coli Nissle suspension
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients receive E. coli Nissle suspension Receives: Drug: E. coli Nissle suspension |
| Control | Placebo comparator | Patients receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Common toxicity criteria for diarrhea Version 4.0
Measured: Baseline vs. week 12
Secondary outcomes (11)
Quality of life by SF-12 questionnaire
Measured: Baseline vs. week 12
Quality of life by FACIT-D questionnaire
Measured: Baseline vs. week 12
stool consistency by Bristol stool scale
Measured: Baseline vs. week 12
Body mass index in kg/m^2
Measured: Baseline vs. week 12
Phase angle
Measured: Baseline vs. week 12
C-reactive protein
Measured: Baseline vs. week 12
Hematocrit
Measured: Baseline vs. week 12
alpha-1-Antitrypsin
Measured: Baseline vs. week 12
Calprotectin
Measured: Baseline vs. week 12
Body cell mass in kg
Measured: Baseline vs. week 12
ECM/BCM-Index
ECM = extracellular mass BCM = body cell mass
Measured: Baseline vs. week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Hohenheim
- Sponsor type
- University, hospital or other
- Collaborators
- Ardeypharm GmbH
- Responsible party
- Sponsor
- Investigators
- Stephan C. Bischoff, Prof., Study director, ZKES GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706184
- Sponsor's protocol ID
- ZKES-EcNO-2015
- Acronym
- EcNO
- Status last verified
- May 2018
- First submitted
- 23 Feb 2016
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02706184
- Acronym / sponsor ID
- EcNO / ZKES-EcNO-2015
- Conditions
- Gastric Cancer, Colorectal Cancer
- Keywords
- gastric cancer, colorectal cancer, chemotherapy induced diarrhea, 5-Fluoruracil, chemotherapeutic remedy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of HohenheimUniversity, hospital or other
- Collaborators
- Ardeypharm GmbH
- Study start
- Jul 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 11 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: E. coli Nissle suspensionPatients receive E. coli Nissle suspension |
| Control | Placebo comparator | Drug: PlaceboPatients receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E. coli Nissle suspensionAlso: Mutaflor Suspension®Patients receive E. coli Nissle suspension | Drug | Intervention |
| PlaceboPlacebo | Drug | Control |
Primary outcome
Common toxicity criteria for diarrhea Version 4.0
Time frame: Baseline vs. week 12
11 secondary outcomes
Quality of life by SF-12 questionnaire
Time frame: Baseline vs. week 12
Quality of life by FACIT-D questionnaire
Time frame: Baseline vs. week 12
stool consistency by Bristol stool scale
Time frame: Baseline vs. week 12
Body mass index in kg/m^2
Time frame: Baseline vs. week 12
Phase angle
Time frame: Baseline vs. week 12
C-reactive protein
Time frame: Baseline vs. week 12
Hematocrit
Time frame: Baseline vs. week 12
alpha-1-Antitrypsin
Time frame: Baseline vs. week 12
Calprotectin
Time frame: Baseline vs. week 12
Body cell mass in kg
Time frame: Baseline vs. week 12
ECM/BCM-Index
Time frame: Baseline vs. week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan C. Bischoff, Prof. study director
ZKES GmbH
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing E. coli Nissle suspension in people with Gastric Cancer and Colorectal Cancer, run by University of Hohenheim at 5 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common toxicity criteria for diarrhea Version 4.0 (time frame: Baseline vs. week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.