Lung CancerPhase 1NCT02771470
Intestinal Microflora in Lung Cancer After Chemotherapy
A Phase 1 study testing Probiotics in people with Lung Cancer and Effects of Chemotherapy, run by Shandong University at 1 site in China.
Trial summary
Probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer, Effects of Chemotherapy, Tumor Immunity
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Jul 2016
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for chemotherapy of lung cancer
Who cannot join
- Antibiotic, probiotic or prebiotic usage within 1month
- Other malignancy
- History of abdominal surgery
- Pregnant or breast-feeding (for females)
- Impaired liver or renal function
- Diabetes, thyroid disorder, coagulopathy or bleeding disorders, mental disorder
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, 250012
About this study
Probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy.
Read the detailed description
Chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications. Probiotics may restore the intestinal immunity, mucosal barrier and nutrient absorption.
- Conditions
- Lung Cancer, Effects of Chemotherapy, Tumor Immunity, Malnutrition
- Being tested
- Probiotics, placebo
- Keywords
- Gut microflora, Lung cancer, Chemotherapy, Immunity, Nutrition
- Medical subject headings
- Lung Neoplasms, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDrug
Also called containing clostridium butyricum
Microbial composition using probiotic
placeboDrug
Microbiota modulation using placebo
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Microbial composition using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks Receives: Drug: Probiotics |
| Placebo | Placebo comparator | Microbiota modulation using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of Microorganisms in stool after probiotic intervention
Primary coordination of fecal samples' 16s(%) rDNA will be compared between two groups using Braycurtis distance based Primary coordination analysis(PCoA)
Measured: 2 months
Secondary outcomes (2)
Frequency and severity of Adverse effects during Chemotherapy
Measured: 2 months
The change of immunity and nutrition index
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startSep 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, MD.PhD., Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02771470
- Sponsor's protocol ID
- 2014SDU-QILU-G06
- Status last verified
- May 2017
- First submitted
- 14 Jul 2015
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Microflora in Lung Cancer After Chemotherapy
- ClinicalTrials.gov ID
- NCT02771470
- Acronym / sponsor ID
- 2014SDU-QILU-G06
- Conditions
- Lung Cancer, Effects of Chemotherapy, Tumor Immunity, Malnutrition
- Keywords
- Gut microflora, Lung cancer, Chemotherapy, Immunity, Nutrition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 13 May 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.
Probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy.
Detailed description
Chemotherapy destroys the intestinal mucosal barrier, affects intestinal flora, causing bacterial translocation, infection and other complications. Probiotics may restore the intestinal immunity, mucosal barrier and nutrient absorption.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Drug: ProbioticsMicrobial composition using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks |
| Placebo | Placebo comparator | Drug: placeboMicrobiota modulation using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for chemotherapy of lung cancer
Key exclusion criteria (6 listed)
- Antibiotic, probiotic or prebiotic usage within 1month
- Other malignancy
- History of abdominal surgery
- Pregnant or breast-feeding (for females)
- Impaired liver or renal function
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 |
|---|---|---|
| ProbioticsAlso: containing clostridium butyricumMicrobial composition using probiotic | Drug | Probiotic |
| placeboMicrobiota modulation using placebo | Drug | Placebo |
Primary outcome
Composition of Microorganisms in stool after probiotic intervention
Time frame: 2 months
Primary coordination of fecal samples' 16s(%) rDNA will be compared between two groups using Braycurtis distance based Primary coordination analysis(PCoA)
2 secondary outcomes
Frequency and severity of Adverse effects during Chemotherapy
Time frame: 2 months
The change of immunity and nutrition index
Time frame: 2 months
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 23 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Yanqing Li, MD.PhD. study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Probiotics in people with Lung Cancer and Effects of Chemotherapy, run by Shandong University at 1 site in China.
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 1 inclusion and 6 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 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Composition of Microorganisms in stool after probiotic intervention (time frame: 2 months). 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 23 May 2017.