Trial Outcomes & Findings for Effect of Probiotics in Non-alcoholic Fatty Liver Disease and Steatohepatitis (NCT NCT04175392)

Results Overview

Probiotic effects on liver fibrosis as measured by transient elastography, as a change from baseline to 6 months, measured on a scale from 1-4. 1= a clinical grade of F0-F1 and represents 2-7 kilopascals in elastography testing. 4= a clinical grade of F4 and represents 14 kilopascals or higher in elastography testing. A higher score on the scale represents worsening liver scarring. Positive numbers indicate an increase in fibrosis; negative numbers indicate decrease in fibrosis.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

14 participants

Primary outcome timeframe

6 months

Results posted on

2022-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group: Probiotic Probiotic 1 billion units Supplement Once Daily Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily	Control Group: Placebo Placebo Capsule Once Daily Placebos: Placebos capsule 1 capsule Once daily
Overall Study STARTED	7	7
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group: Probiotic Probiotic 1 billion units Supplement Once Daily Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily	Control Group: Placebo Placebo Capsule Once Daily Placebos: Placebos capsule 1 capsule Once daily
Overall Study Withdrawal by Subject	3	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group: Probiotic n=7 Participants Probiotic 1 billion units Supplement Once Daily Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily	Control Group: Placebo n=7 Participants Placebo Capsule Once Daily Placebos: Placebos capsule 1 capsule Once daily	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=7 Participants	7 Participants n=7 Participants	14 Participants n=14 Participants
Age, Categorical >=65 years	0 Participants n=7 Participants	0 Participants n=7 Participants	0 Participants n=14 Participants
Sex: Female, Male Female	5 Participants n=7 Participants	4 Participants n=7 Participants	9 Participants n=14 Participants
Sex: Female, Male Male	2 Participants n=7 Participants	3 Participants n=7 Participants	5 Participants n=14 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	7 participants n=7 Participants	7 participants n=7 Participants	14 participants n=14 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Only 1 participant in group 1 and 2 participants in group 2 completed the 6 month fibroscan. Data available only for these participants.

Probiotic effects on liver fibrosis as measured by transient elastography, as a change from baseline to 6 months, measured on a scale from 1-4. 1= a clinical grade of F0-F1 and represents 2-7 kilopascals in elastography testing. 4= a clinical grade of F4 and represents 14 kilopascals or higher in elastography testing. A higher score on the scale represents worsening liver scarring. Positive numbers indicate an increase in fibrosis; negative numbers indicate decrease in fibrosis.

Outcome measures

Outcome measures
Measure	Treatment Group: Probiotic n=1 Participants Probiotic 1 billion units Supplement Once Daily Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily	Control Group: Placebo n=2 Participants Placebo Capsule Once Daily Placebos: Placebos capsule 1 capsule Once daily
Probiotic Effects on Liver Fibrosis	-1 units on a 1-4 scale Standard Deviation 0	0 units on a 1-4 scale Standard Deviation 0

SECONDARY outcome

Timeframe: 6 months

Population: 2 participants in the treatment group and 2 participants in the placebo group withdrew before 6 months: data not available for these 4 participants.

Probiotic effects on Liver enzymes, AST as a change from baseline to 6 months, measured in units per liter. Positive numbers indicate an increase in AST; negative numbers indicate decrease in AST

Outcome measures

Outcome measures
Measure	Treatment Group: Probiotic n=5 Participants Probiotic 1 billion units Supplement Once Daily Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily	Control Group: Placebo n=5 Participants Placebo Capsule Once Daily Placebos: Placebos capsule 1 capsule Once daily
Probiotic Effects on Liver Enzymes, AST	-3.8 units per liter Standard Deviation 15.0	4.0 units per liter Standard Deviation 13.9

SECONDARY outcome

Timeframe: 6 months

Population: 2 participants in the treatment group and 2 participants in the placebo group withdrew before 6 months: data not available for these 4 participants.

Probiotic effects on Liver enzymes, ALT as a change from baseline to 6 months, measured in units per liter. Positive numbers indicate an increase in ALT; negative numbers indicate decrease in ALT

Outcome measures

Outcome measures
Measure	Treatment Group: Probiotic n=5 Participants Probiotic 1 billion units Supplement Once Daily Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily	Control Group: Placebo n=5 Participants Placebo Capsule Once Daily Placebos: Placebos capsule 1 capsule Once daily
Probiotic Effects on Liver Enzymes, ALT	2.2 units per liter Standard Deviation 27.3	-4.6 units per liter Standard Deviation 26.3

SECONDARY outcome

Timeframe: 6 months

Population: 4 participants in the control group and 3 participants in the placebo group did not have this test performed: data not available for these 7 participants.

Probiotic effects on Diabetic Markers as measured by hemoglobin A1C blood test as a change from baseline to 6 months, measured in percent. Positive numbers indicate an increase in hemoglobin A1c; negative numbers indicate decrease in hemoglobin A1c

Outcome measures

Outcome measures
Measure	Treatment Group: Probiotic n=3 Participants Probiotic 1 billion units Supplement Once Daily Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily	Control Group: Placebo n=4 Participants Placebo Capsule Once Daily Placebos: Placebos capsule 1 capsule Once daily
Probiotic Effects on Diabetic Markers	.63 percentage of total hemoglobin Standard Deviation .5	.15 percentage of total hemoglobin Standard Deviation .2

SECONDARY outcome

Timeframe: 6 months

Population: 4 participants in the control group and 2 participants in the placebo group did not have BMI completed at 6 months: data not available for these 6 participants.

Probiotic effects on Body Mass Index (BMI) wherein weight and height will be combined to report BMI in kg/m\^2 as a change from baseline to 6 months. Positive numbers indicate an increase in BMI; negative numbers indicate decrease in BMI.

Outcome measures

Outcome measures
Measure	Treatment Group: Probiotic n=3 Participants Probiotic 1 billion units Supplement Once Daily Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily	Control Group: Placebo n=5 Participants Placebo Capsule Once Daily Placebos: Placebos capsule 1 capsule Once daily
Probiotic Effects on BMI	-.26 kg/m^2 Standard Deviation 1.5	-1.85 kg/m^2 Standard Deviation 2.6

SECONDARY outcome

Timeframe: 6 months

Population: 4 participants in the treatment group and 4 participants in the placebo group did not have LDL completed at 6 months: data not available for these 8 participants.

Probiotic effects on Low-density Lipoprotein (LDL) as a change from baseline to 6 months, measured in milligrams per deciliter. Positive numbers indicate an increase in LDL; negative numbers indicate decrease in LDL

Outcome measures

Outcome measures
Measure	Treatment Group: Probiotic n=3 Participants Probiotic 1 billion units Supplement Once Daily Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily	Control Group: Placebo n=3 Participants Placebo Capsule Once Daily Placebos: Placebos capsule 1 capsule Once daily
Probiotic Effects on LDL	-9.3 milligrams per deciliter Standard Deviation 32.4	29.75 milligrams per deciliter Standard Deviation 45.4

Adverse Events

Treatment Group: Probiotic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group: Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment Group: Probiotic n=7 participants at risk Probiotic 1 billion units Supplement Once Daily Align Probiotic Supplement Capsule: Align Probiotic 1 billion units, 1 capsule once daily	Control Group: Placebo n=7 participants at risk Placebo Capsule Once Daily Placebos: Placebos capsule 1 capsule Once daily
Gastrointestinal disorders Increased gas	0.00% 0/7 • 6 months	42.9% 3/7 • Number of events 3 • 6 months
Gastrointestinal disorders Diarrhea	0.00% 0/7 • 6 months	14.3% 1/7 • Number of events 1 • 6 months

Additional Information

Kirsten Gage, CRM

Beaumont Hospitals

Phone: 947-521-8519

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place