Trial Outcomes & Findings for Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis (NCT NCT01654549)

Results Overview

Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment). The percent of liver fat was calculated as below: "Liver fat content (%) = 10 (-0.805 + 0.282 \* metabolic syndrome (yes = 1 / no = 0) + 0.078 \* type 2 diabetes (yes =2 / no =0) + 0.525 \* log fasting serum insulin (mU/L) + 0.521 \* log fasting serum AST (U/L) - 0.454 \* log (AST/ALT)"

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

8 weeks (6 weeks post-treatment)

Results posted on

2018-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Lifestyle Modification Obtaining ideal body weight by calorie restriction diet and programmed physical activity	H.Pylori Eradication H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
Overall Study STARTED	20	20
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Lifestyle Modification Obtaining ideal body weight by calorie restriction diet and programmed physical activity	H.Pylori Eradication H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
Overall Study H.pylori eradication not successful	0	1

Baseline Characteristics

Helicobacter Pylori Eradication in Non-diabetic Non-alcoholic Steatohepatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lifestyle Modification n=20 Participants Obtaining ideal body weight by calorie restriction diet and programmed physical activity	H.Pylori Eradication n=20 Participants H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity	Total n=40 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	20 Participants n=5 Participants	20 Participants n=7 Participants	40 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	42.90 years STANDARD_DEVIATION 13.96 • n=5 Participants	41.11 years STANDARD_DEVIATION 10.14 • n=7 Participants	41.57 years STANDARD_DEVIATION 12.30 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Iran, Islamic Republic of	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks (6 weeks post-treatment)

Primary outcome measure was changes in the liver fat content from baseline to the end of study (6 weeks post-treatment). The percent of liver fat was calculated as below: "Liver fat content (%) = 10 (-0.805 + 0.282 \* metabolic syndrome (yes = 1 / no = 0) + 0.078 \* type 2 diabetes (yes =2 / no =0) + 0.525 \* log fasting serum insulin (mU/L) + 0.521 \* log fasting serum AST (U/L) - 0.454 \* log (AST/ALT)"

Outcome measures

Outcome measures
Measure	Liver Fat Content in H.Pylori Eradication at Baseline n=19 Participants Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at baseline	Liver Fat Content in H.Pylori Eradication at 8 Weeks n=19 Participants Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at 8 weeks	Liver Fat Content in Lifestyle Modification at Baseline n=20 Participants Liver fat content in lifestyle modification group at baseline	Liver Fat Content in Lifestyle Modification at 8 Weeks n=20 Participants Liver fat content in lifestyle modification group at 8 weeks	Liver Fat Content Change in H.Pylori Eradication n=19 Participants The change of liver fat content from baseline to the end of study in H.pylori eradication group	Liver Fat Content Change in Lifestyle Modification n=20 Participants The change of liver fat content from baseline to the end of study in lifestyle modification group
Liver Fat Content	8.38 percentage of liver fat content Standard Deviation 4.47	7.72 percentage of liver fat content Standard Deviation 4.34	8.50 percentage of liver fat content Standard Deviation 6.03	7.29 percentage of liver fat content Standard Deviation 5.06	0.66 percentage of liver fat content Standard Deviation 0.61	1.21 percentage of liver fat content Standard Deviation 1.31

SECONDARY outcome

Timeframe: 8 weeks

Secondary outcome measure was change in serum alanine aminotransferase concentration from baseline to the end of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Secondary outcome measure was change in serum aspartate aminotransferase concentration from baseline to the end of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Secondary outcome measure was change in fasting serum glucose concentration from baseline to the end of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Secondary outcome measure was change in serum lipid profile (including serum triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein concentration) from baseline to the end of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Secondary outcome measure was change in HOMA-IR from baseline to the end of study

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 8 weeks

Secondary outcome measure was change in anthropometric measurements (body mass index and waist circumference) from baseline to the end of study

Outcome measures

Outcome data not reported

Adverse Events

H. Pylori Eradication

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Intervention

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 Raika Jamali

Tehran University of Medical Sciences

Phone: 982163120000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place