Helicobacter pylori infection. Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Conditions
Interventions
Intervention 1: Supplementation of 500 mg of pomegranate peel extract (manufactured by Adib Elixir Company) twice a day for eight weeks. Intervention 2: Control group: 500 mg placebo supplement (manuf
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patient consent to participate in the study Age between 18 years and 65 years BMI less than 30 kg/m2 Diagnosis of Helicobacter pylori infection by endoscopy if there is an indication or otherwise by a positive fecal antigen test or urea breath test (UBT) and confirmation by a specialist doctor Not having a history of drug treatment to eradicate Helicobacter pylori infection Absence of gastric surgery No history of peptic ulcer User of four-drug and 14-day treatment protocol to eradicate Helicobacter pylori infection including amoxicillin, clarithromycin, bismuth and PPI
Exclusion criteria
Exclusion criteria: Pregnant or lactating women Suffering from other stomach diseases and disorders, autoimmune diseases, types of cancers, infectious diseases and respiratory inflammations such as asthma Use of multivitamin-mineral, omega-3, polyphenolic, antioxidants, and herbal supplements during the last month Taking antibiotics and bismuth in the last 2 months Using drugs including corticosteroids, NSAIDs (ibuprofen, aspirin and diclofenac) and anti-TNF drugs (Cinnura or Adalimumab, Infliximab or Remicade) Heavy bleeding during women's menstruation Suffering from chronic constipation and hemorrhoids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eradication of Helicobacter pylori infection. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: by endoscopy if indicated or otherwise by positive stool antigen test or urea breath test (UBT) and the approval of a specialist doctor.;Inflammatory factors. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: ELISA test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastrointestinal Symptoms Questionnaire (GSRS) This questionnaire consists of five groups of symptoms including reflux, abdominal pain, indigestion, diarrhea and constipation. Timepoint: The beginning of the study (before the start of the intervention), the end of the study (8 weeks after the start of the intervention). Method of measurement: Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFarzad Shidfar
Iran University of Medical Sciences
Outcome results
None listed