Trial Outcomes & Findings for Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients (NCT NCT01593592)

NCT ID: NCT01593592

Last Updated: 2015-08-17

Results Overview

H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: 4 weeks therapy
• Results posted on: 2015-08-17

Participant Flow

All adult dyspeptic patients presented to outpatient gastroenterology clinics of the Tropical Medicine and Internal Medicine Departments, Faculty of Medicine, Zagazig University Hospitals, Egypt from June 2012 to February 2013 were offered to share in the study

Participant milestones

Measure	Control Group The control group that will receive the standard triple therapy and placebo Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.	Lactobacillus Reuteri Group The active group that will receive the standard triple therapy and Lactobacillus reuteri Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

Baseline characteristics by cohort

Measure	Lactobacillus Reuteri Group n=35 Participants The active group that will receive the standard triple therapy and Lactobacillus reuteri	Control Group n=35 Participants The control group that will receive the standard triple therapy and placebo	Total n=70 Participants Total of all reporting groups
Age, Continuous	33.20 years n=5 Participants	36.80 years n=7 Participants	35.00 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	24 Participants n=7 Participants	46 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
ِAge	33.20 years STANDARD_DEVIATION 13.974 • n=5 Participants	36.80 years STANDARD_DEVIATION 11.085 • n=7 Participants	35.00 years STANDARD_DEVIATION 12.650 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks therapy

Population: It is assessment of all the 70 participants about H pylori eradication status

H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy.

Outcome measures

Measure	Control Group n=35 Participants The control group that will receive the standard triple therapy and placebo Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.	Lactobacillus Reuteri Group n=35 Participants The active group that will receive the standard triple therapy and Lactobacillus reuteri Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.
Eradication of H Pylori Infection 4 Weeks After Completion of Therapy	23 participants	26 participants

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Measure	Control Group n=35 Participants The control group that will receive the standard triple therapy and placebo Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.	Lactobacillus Reuteri Group n=35 Participants The active group that will receive the standard triple therapy and Lactobacillus reuteri Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.
Severe Adverse Effects to the Used Medications and Dietary Supplements.	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them.

Outcome measures

Measure	Control Group n=35 Participants The control group that will receive the standard triple therapy and placebo Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.	Lactobacillus Reuteri Group n=35 Participants The active group that will receive the standard triple therapy and Lactobacillus reuteri Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.
The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.	0 participants	0 participants

Adverse Events

Lactobacillus Reuteri Group

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lactobacillus Reuteri Group n=35 participants at risk The active group that will receive the standard triple therapy and Lactobacillus reuteri Lactobacillus reuteri: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.	Control Group n=35 participants at risk The control group that will receive the standard triple therapy and placebo Placebo: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.
Reproductive system and breast disorders Galactorrhea	0.00% 0/35 • 8 weeks Patients were followed up for 8 weeks to report any adverse events and side effects	2.9% 1/35 • 8 weeks Patients were followed up for 8 weeks to report any adverse events and side effects
Gastrointestinal disorders Taste disorders	5.7% 2/35 • 8 weeks Patients were followed up for 8 weeks to report any adverse events and side effects	22.9% 8/35 • 8 weeks Patients were followed up for 8 weeks to report any adverse events and side effects
Gastrointestinal disorders Diarrhea	2.9% 1/35 • 8 weeks Patients were followed up for 8 weeks to report any adverse events and side effects	28.6% 10/35 • 8 weeks Patients were followed up for 8 weeks to report any adverse events and side effects
Gastrointestinal disorders Distension	14.3% 5/35 • 8 weeks Patients were followed up for 8 weeks to report any adverse events and side effects	11.4% 4/35 • 8 weeks Patients were followed up for 8 weeks to report any adverse events and side effects
Gastrointestinal disorders Vomiting	5.7% 2/35 • 8 weeks Patients were followed up for 8 weeks to report any adverse events and side effects	5.7% 2/35 • 8 weeks Patients were followed up for 8 weeks to report any adverse events and side effects

Additional Information

Dr Mohamed Emara

Tropical Medicine Departement, Faculty of Medicine, Zagazig University, Egypt

Phone: +2 0100 272 4482

Email: emara_20007@yahoo.com

Results disclosure agreements

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