NCT02771470

Brief Summary

Probiotics modulate the gut microflora and immune status in lung cancer who need chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1 lung-cancer

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_1 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 13, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

1.8 years

First QC Date

July 14, 2015

Last Update Submit

May 21, 2017

Conditions

Lung CancerEffects of ChemotherapyTumor ImmunityMalnutrition

Keywords

Gut microfloraLung cancerChemotherapyImmunityNutrition

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Frequency and severity of Adverse effects during Chemotherapy

    2 months

  • The change of immunity and nutrition index

    2 months

Study Arms (2)

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

ProbioticsDRUG

Microbial composition using probiotic

Also known as: containing clostridium butyricum
Probiotic
placeboDRUG

Microbiota modulation using placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for chemotherapy of lung cancer

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Lung NeoplasmsMalnutrition

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Yanqing Li, MD.PhD.

    Qilu Hospital of Shandong University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Qilu Hospital

Study Record Dates

First Submitted

July 14, 2015

First Posted

May 13, 2016

Study Start

September 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations

CN(1)