Trial Outcomes & Findings for Beneficial Effect of Probiotics on Chronic Kidney Disease (NCT NCT01391468)

NCT ID: NCT01391468

Last Updated: 2015-11-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 47 participants
• Primary outcome timeframe: 6 month follow-up
• Results posted on: 2015-11-03

Participant Flow

Participant milestones

Measure	Placebo Cornstarch: placebo will be given in 6 months	Probiotics Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
Overall Study STARTED	24	23
Overall Study COMPLETED	18	21
Overall Study NOT COMPLETED	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Beneficial Effect of Probiotics on Chronic Kidney Disease

Baseline characteristics by cohort

Measure	Placebo n=24 Participants Cornstarch: placebo will be given in 6 months	Probiotics n=23 Participants Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations	Total n=47 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment Taiwan	24 participants n=5 Participants	23 participants n=7 Participants	47 participants n=5 Participants
IL-6	5.27 pg/ml STANDARD_DEVIATION 12.78 • n=5 Participants	6.55 pg/ml STANDARD_DEVIATION 10.72 • n=7 Participants	5.90 pg/ml STANDARD_DEVIATION 11.71 • n=5 Participants

PRIMARY outcome

Timeframe: 6 month follow-up

Outcome measures

Measure	Placebo n=18 Participants Cornstarch: placebo will be given in 6 months	Probiotics n=21 Participants Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
the Occurrence of Cardiovascular Event and Peritonitis Events Cardiovascular event	0 participants	0 participants
the Occurrence of Cardiovascular Event and Peritonitis Events Peritonitis event	0 participants	0 participants

SECONDARY outcome

Timeframe: 6 months follow-up

The change in gastrointestinal symptom rating scale (min and maximum scores 0-45) after treatment. The total score is reported. The higher scale represents a worse outcome.

Outcome measures

Measure	Placebo n=18 Participants Cornstarch: placebo will be given in 6 months	Probiotics n=21 Participants Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
Change of Gastrointestinal Symptoms at 6 Months	-2.82 units on a scale Standard Deviation 5	-1.38 units on a scale Standard Deviation 3.25

POST_HOC outcome

Timeframe: 6 months follow-up

endotoxin is a marker of inflammation in chronic kidney disease patients

Outcome measures

Measure	Placebo n=21 Participants Cornstarch: placebo will be given in 6 months	Probiotics n=18 Participants Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
Change of Serum Endotoxin Level at 6 Months	-1.31 EU/ml Standard Deviation 1.61	0.84 EU/ml Standard Deviation 2.27

POST_HOC outcome

Timeframe: 6 months

IL-10 is an anti-inflammatory cytokine; The change of serum IL-10 level at 6 months was measured

Outcome measures

Measure	Placebo n=21 Participants Cornstarch: placebo will be given in 6 months	Probiotics n=18 Participants Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
Change of Serum IL-10 Level at 6 Months	3.3 pg/ml Standard Deviation 6.37	-2.09 pg/ml Standard Deviation 6.73

Adverse Events

Probiotics

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

II-Kuan Wang

China Medical University

Phone: 88975681050

Email: ikwang@seed.net.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place