Intestinal Microflora in Lung Cancer After Chemotherapy | NCT02771470

Studies
Intestinal Microflora in Lung Cancer After Chemotherapy

NCT02771470

Sponsor

Shandong University

Status

Completed

Last Update Posted

May 23, 2017Actual

Enrollment

41Actual

Phase

Phase 1

Conditions

Lung Cancer
Effects of Chemotherapy
Tumor Immunity
Malnutrition

Interventions

Probiotics
placebo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Jul 2016Actual

Completion Date

Jul 2016Actual

First Submitted Date

Jul 14, 2015

First Submission Date that Met QC Criteria

May 10, 2016

First Posted Date

May 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2017

Last Update Posted Date

May 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Probiotic	Experimental	Microbial composition using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks	Drug: Probiotics
Placebo	Placebo Comparator	Microbiota modulation using probiotics,3 capsules/times,3 times/day for 3 to 4 weeks	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Probiotics	Drug	Microbial composition using probiotic	Probiotic	containing clostridium butyricum

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	2 months

Secondary Outcomes

Measure	Description	Time Frame
Frequency and severity of Adverse effects during Chemotherapy		2 months
The change of immunity and nutrition index		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled for chemotherapy of lung cancer

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yanqing Li, MD.PhD.	Qilu Hospital of Shandong University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology,Qilu Hospital,Shandong University		Jinan	Shandong	250012	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Mar 7, 2018
Reset	Oct 5, 2018

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 7, 2018			Oct 5, 2018

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D044342	Malnutrition

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided