Probiotic for eradication of helicobacter pylori

Evaluating the effects of adding the probiotic Balance® compared with placebo to quadruple therapy on eradication of helicobacter pylori and symptoms of patients with peptic ulcer disease referring to gastroenterology clinics in Isfahan

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201209041579N4

Enrollment

180

Registered

2012-10-03

Start date

2011-07-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Helicobacter pylori infection. Helicobacter pylori [H.pylori] as the cause of diseases classified

Interventions

Intervention 1: Intervention group: - Quadruple therapy regimen for helicobacter pylori eradication including Omeprazole 20 mg (Sobhan Co., Tehran, Iran) twice daily, Bismuth subcitrate 240 mg (Chemie

Treatment - Drugs

Placebo

Intervention group: - Quadruple therapy regimen for helicobacter pylori eradication including Omeprazole 20 mg (Sobhan Co., Tehran, Iran) twice daily, Bismuth subcitrate 240 mg (ChemieDarou Co., Tehra

Control group: - Quadruple therapy regimen for helicobacter pylori eradication including Omeprazole 20 mg (Sobhan Co., Tehran, Iran) twice daily, Bismuth subcitrate 240 mg (ChemieDarou Co., Tehran, I

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: - Age 18 to 65 years, - Having peptic ulcer disease on upper gastrointestinal endoscopy, - Having helicobacter pylori infection diagnosed by rapid urease test or urea breath test, - Willingness to participate in the study, - Not having Zollinger Ellison Syndrome, cancers of the digestive tract, liver or kidney diseases, other infections may require antibiotics, immune deficiency disease, - No history of upper gastrointestinal surgery, - No history of the eradication of Helicobacter pylori, or the use of Proton Pomp Inhibitors, antibiotics, and probiotics (synthetic or natural) over the past 4 weeks, - No contraindications for using any dug of the quadruple therapy. Exclusion criteria: - Not taking medications regularly, (not taking >= 20% of all the prescribed capsules), - Severe side effects of the quadruple therapy.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Helicobacter pylori eradication. Timepoint: Four weeks after treatment. Method of measurement: Urea breath test.	—

Secondary

Measure	Time frame
Dyspepsia symptoms severity. Timepoint: At baseline, 15th day, and 4 weeks after treatment. Method of measurement: Lead Dyspepsia Questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Elham Tabesh

Isfahan University of Medical Sciences

elham7979@yahoo.com+98 31 1792 2472

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026