The effect of probiotics in the treatment of H.pylori infection

The comparison between the probiotic supplementation and the placebo on the tolerance and efficacy of quadruple therapy in helicobacter pylori positive patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201011135174N1

Enrollment

Registered

2011-05-10

Start date

2011-05-05

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

Condition 1: Dyspepsia. Condition 2: Gastric ulcer. Condition 3: Duodenal ulcer. Indigestion erosion (acute) of stomach, ulcer (peptic): pylorus,stomach erosion (acute) of duodenum, ulcer (peptic): duodenal-postpyloric

Interventions

Intervention 1: The intervention group: probiotic Protexin BALANCE, 2 Capsules, daily, 17 days. Intervention 2: The control group: Placebo, 2 capsules, daily, 17days.

Treatment - Drugs

Placebo

The intervention group: probiotic Protexin BALANCE, 2 Capsules, daily, 17 days

The control group: Placebo, 2 capsules, daily, 17days

Eligibility

Sex/Gender

All

Age

15 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criterion: diagnosed h.pylori infection by histopathology of the biopsy specimen. Exclusion criteria: malignancy; prior h.pylori eradication; GI bleeding; prior gastrectomy; inflammatory bowel disease; immunodeficiency; valvular heart disease; consuming any probiotic supplementation in treatment period.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
H.pylori eradication rate. Timepoint: 6 weeks and 3 days after the beginning of the intervention. Method of measurement: Urea breath test.;Diarrhea. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.;Epigastric pain. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.;Nausea. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.;Flatulence. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.;Taste disorder. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.;Constipation. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.	—

Measure

Time frame

H.pylori eradication rate. Timepoint: 6 weeks and 3 days after the beginning of the intervention. Method of measurement: Urea breath test.;Diarrhea. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.;Epigastric pain. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.;Nausea. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.;Flatulence. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.;Taste disorder. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.;Constipation. Timepoint: 10, 17 and 24 days after the beginning of the intervention. Method of measurement: Modified version of the questionnaire by de Boer et al.

—

Secondary

Measure	Time frame
Benign peptic ulcer. Timepoint: At the begining of the trial. Method of measurement: Gastroduodenoscopy.;Duodenal ulcer. Timepoint: At the begining of the trial. Method of measurement: Gastroduodenoscopy.;Nonulcer dyspepsia. Timepoint: At the begining of the trial. Method of measurement: Gastroduodenoscopy.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Afshin Shafaghi

Guilan University of Medical Sciences

mohsen41499@yahoo.com+98 13 1555 4593

Outcome results

None listed

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