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Study of Synbiotics Prescription on the Efficacy and Tolerability of a 4-Drug Helicobacter Pylori Eradication Regime

Studying the effect of synbiotics on the efficacy and tolerability of a 4-drug Helicobacter pylori eradication regimen in treatment-naive patients: A triple-blind randomized clinical trial study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251105067883N1
Enrollment
204
Registered
2026-02-01
Start date
2026-01-05
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Helicobacter pylori infection. B98.0 Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters

Interventions

Intervention 1: Intervention group A: Patients will receive synbiotics for the first two weeks and the second two weeks. Intervention 2: Control group: Patients who will receive placebo in the first t

Sponsors

Shahre-kord University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Consent to participate in the study Patients over 18 years of age with H. pylori infection for which the infection has been proven for the first time No history of recent treatment failure Absence of any serious underlying disease such as neoplasms, gastric ulcers, dementia, and Alzheimer's disease

Exclusion criteria

Exclusion criteria: Allergies or side effects related to medications used in the study Taking antibiotics at the same time during the course

Design outcomes

Primary

MeasureTime frame
Eradication of Helicobacter pylori infection. Timepoint: 4 weeks after completion of standard treatment course. Method of measurement: Helicobacter pylori fecal antigen testing.

Secondary

MeasureTime frame
Adherence to treatment. Timepoint: On days 14 and 28 after starting treatment. Method of measurement: Counting unused medications.;Side effects of disease and medication. Timepoint: Before intervention and on days 14, 28, and 42. Method of measurement: Short questionnaire.;Patient demographic information including age, gender, underlying disease, etc. Timepoint: Before the intervention. Method of measurement: Short questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAhmad Reesi

Shahre-kord University of Medical Sciences

raesi.ah@skums.ac.ir+98 38 3110 7001

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026