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The effect of Quadruple Therapy with Saccharomyces Boulardii or a Lactobacillus Reuteri Strain DSMZ 17648 Supplement (PYLOSHOT®) on Eradication of Helicobacter Pylori and Treatment Side Effects

The effect of Quadruple Therapy with Saccharomyces Boulardii or a Lactobacillus Reuteri Strain DSMZ 17648 Supplement (PYLOSHOT®) on Eradication of Helicobacter Pylori and Treatment Side Effects: a Double-Blind Placebo-Controlled Randomized Clinical Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200106046021N1
Enrollment
156
Registered
2020-01-14
Start date
2020-01-08
Completion date
Unknown
Last updated
2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric infection with Helicobacter pylori.

Interventions

Intervention 1: Control group: Taking placebo capsules that are completely identical to supplements in weight, size, shape and taste for 14 days in combination with the standard four-dose regimen for

Sponsors

Birjand University of Medical Sciences
Lead Sponsor
ZIST TAKHMIR Pharmaceutical company
Collaborator

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

Inclusion criteria: Symptoms of H. pylori-positive as Confirmed by Clinical, Endoscopic, and Pathological Reports.

Exclusion criteria

Exclusion criteria: Pregnancy and lactation Patients with Liver, CardioPulmonary, Renal, Neoplastic Diseases People taking Proton Pump Inhibitors, Bismuth Salts, or Probiotics for the past 4 weeks and any Immuno Suppressive Drugs Surgery such as Gastrectomy or Gastric Bypass The existence of Autoimmune Diseases IBD (Inflammatory Bowel Disease) Organ Transplant Weight loss over 3kg over the past three months Previous History of Helicobacter Pylori Eradication Oral Antibiotic use in less than 3 months Alcohol abuse Participate in Other Clinical Trials Concurrently

Design outcomes

Primary

MeasureTime frame
Mean recovery time in study groups. Timepoint: 2 and 6 weeks after the end of treatment. Method of measurement: Stool Antigen Test.;Frequency distribution of treatment side effects in study groups. Timepoint: During treatment weekly. Method of measurement: Using the questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNushin Naghibzadeh

Birjand University of Medical Sciences

nushin_naghibzadeh@bums.ac.ir+98 56 3162 2035

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 19, 2026