LactoBismu: Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication

Sponsor

Università degli Studi di Sassari (Other)

Overall Status

Terminated

CT.gov ID

NCT03925818

Collaborator

(none)

Enrollment

Location

Arms

15.8

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Bismuth Subcitrate Potassium Dietary Supplement: Gastrus	N/A

Detailed Description

Bismuth, metronidazole and tetracycline yielded high cure rates for H. pylori infection. Earlier studies suggested that the bismuth quadruple therapy may be effective when given twice-a-day rather than q.i.d. and that b.i.d. therapy was associated with fewer side effects. The addition of the probiotic Lactobacillus reuteri (Gastrus®) to Lactobacillus reuteri (Gastrus®) that has been shown to increase the cure rates by 10-14%. In another study bismuth supplementation with L. reuteri DSM 17938, in a modified low dose quadruple therapy provided good eradication rates (93.3%; 95% CI : 85-99%) in clinical practice.

Study Design

Study Type:

Interventional

Actual Enrollment :

99 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Twice-a-day PPI, Tetracycline, Metronidazolequadruple Therapy With Pylera® or Lactobacillus Reuteri for Treatment naïve or for Retreatment of H. Pylori: Two Randomized Pilot Studies

Actual Study Start Date :

Aug 29, 2017

Actual Primary Completion Date :

Nov 29, 2018

Actual Study Completion Date :

Dec 23, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: B.I.D. TMPPI + Lactobacillus-10 pantoprazole 20 mg, tetracycline 500 mg, and metronidazole 500 mg twice a day supplemented with 1 capsule (2 x 108 CFU of L. reuteri DSM 17938 plus 2 x 108 CFU of L. reuteri ATCC PTA 6475) a day in the afternoon, given with the midday and evening meals for 10 days	Drug: Bismuth Subcitrate Potassium Pylera capsules Other Names: Pylera Metronidazole, Tetracycline, pantoprazole, Bismuth
Active Comparator: B.I.D. Bismuth pantoprazole 20 mg and the same doses of antibiotics administered as tetracycline 250 mg, and metronidazole 250 mg plus 1 cp (140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride administered) x 2 all drugs twice-a-day given with the midday and evening meals for 10 days	Dietary Supplement: Gastrus Gastrus 1 tablet Other Names: L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475

Arm

Intervention/Treatment

Experimental: B.I.D. TMPPI + Lactobacillus-10

pantoprazole 20 mg, tetracycline 500 mg, and metronidazole 500 mg twice a day supplemented with 1 capsule (2 x 108 CFU of L. reuteri DSM 17938 plus 2 x 108 CFU of L. reuteri ATCC PTA 6475) a day in the afternoon, given with the midday and evening meals for 10 days

Drug: Bismuth Subcitrate Potassium

Pylera capsules

Other Names:

Pylera

Metronidazole, Tetracycline, pantoprazole, Bismuth

Active Comparator: B.I.D. Bismuth

pantoprazole 20 mg and the same doses of antibiotics administered as tetracycline 250 mg, and metronidazole 250 mg plus 1 cp (140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride administered) x 2 all drugs twice-a-day given with the midday and evening meals for 10 days

Dietary Supplement: Gastrus

Gastrus 1 tablet

Other Names:

L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475

Outcome Measures

Primary Outcome Measures

Helicobacter pylori eradication rate [30-40 days after the end of treatment]
a negative 13C-urea breath test and/or a negative stool antigen test

Secondary Outcome Measures

Compliance and side effects evaluation [30-40 days]
Patient interview at the end of treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Positive for H. pylori infection

Exclusion Criteria:

Presence of malignancy
Pregnancy or lactation
Clinically significant diseases
History of drug or alcohol abuse
Allergy to pantoprazole or to any component of regimens used in the study
Use of anti-secretory drugs, antibiotics or probiotics 4 weeks preceding the enrollment.