Trial Outcomes & Findings for Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease (NCT NCT01501162)

NCT ID: NCT01501162

Last Updated: 2015-04-14

Results Overview

Blood analysis was performed using standard methodologies.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 130 participants
• Primary outcome timeframe: 7 days after probiotics
• Results posted on: 2015-04-14

Participant Flow

Participant milestones

Measure	Alcohol, Hepatitis, Placebo Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.	Hepatitis, Alcohol, Probiotics 7 days of probiotics (1500 mg/day)
Overall Study STARTED	65	65
Overall Study COMPLETED	57	60
Overall Study NOT COMPLETED	8	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Probiotics on Gut-Liver Axis of Alcoholic Liver Disease

Baseline characteristics by cohort

Measure	Alcohol, Hepatitis, Placebo n=57 Participants Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.	Hepatitis, Alcohol, Probiotics n=60 Participants 7 days of probiotics (1500 mg/day)	Total n=117 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	57 Participants n=5 Participants	60 Participants n=7 Participants	117 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	53.8 years STANDARD_DEVIATION 12.4 • n=5 Participants	52.7 years STANDARD_DEVIATION 9.4 • n=7 Participants	52.7 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment Korea, Republic of	57 participants n=5 Participants	60 participants n=7 Participants	117 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days after probiotics

Blood analysis was performed using standard methodologies.

Outcome measures

Measure	Alcohol, Hepatitis, Placebo n=57 Participants Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.	Hepatitis, Alcohol, Probiotics n=60 Participants 7 days of probiotics (1500 mg/day)
Liver Enzymes(ALT)	66 IU/L Standard Deviation 136	48 IU/L Standard Deviation 49

SECONDARY outcome

Timeframe: 7 days after probiotics

For the measurements of cytokines, homogenates of serum were processed with Human Tumor necrosis factor-alpha ELISA Kit and Human interleukin 1 beta ELISA Kit . For the measurement of LPS ELISA Kit was used. Assays were performed according to the manufacturer's instructions.

Outcome measures

Measure	Alcohol, Hepatitis, Placebo n=57 Participants Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.	Hepatitis, Alcohol, Probiotics n=60 Participants 7 days of probiotics (1500 mg/day)
Lipopolysaccharide (LPS) and Pro-inflammatory Cytokines	2.1 EU/mL Standard Deviation 2.7	1.7 EU/mL Standard Deviation 1.6

Adverse Events

Alcohol, Hepatitis, Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hepatitis, Alcohol, Probiotics

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

Dr. Ki Tae Suk

Department of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea

Phone: +82-33-240-5826

Email: ktsuk@hallym.ac.kr

Results disclosure agreements

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