HELICOBACTER PYLORI INFECTIONS
Conditions
Keywords
Helicobacter Pylori, Lignin, Eradication, Side effects
Brief summary
The goal of this clinical trial is to learn if drug hydrolyzed lignin works to treat H pylori infection in adults. It will also learn about the safety of drug lignin n the sitting of H pylori infection, and if it halts the side effects associated with H pylori triple therapy. The main questions it aims to answer are: * Does drug hydrolyzed lignin improve the H pylori eradiation rate when it is added to the standard triple therapy used in treatment of H pylori? * What medical problems do participants experience when taking drug hydrolyzed lignin? Researchers will compare drug hydrolyzed lignin to a placebo (a look-alike substance that contains no drug) to see if drug hydrolyzed lignin works to treat H pylori. Participants will: * Take drug hydrolyzed lignin or a placebo every day for 2 weeks beside the standard triple therapy * Visit the clinic once every 1 week for checkup and questionnaire filling * Check for H pylori eradication after treatment
Interventions
DRUGHydrolyzed Lignin
The drug will be supplied randomly to the group I
OTHERPlacebo
Will be supplied randomly to Group II
Sponsors
EVERGREEN MEDICAL COMPANY
Kafrelsheikh University
Al-Azhar University, Egypt
Ain Shams University, Egypt
Security Forces Hospital Riyadh, Saudi Arabia
Alyousif Hospital, Alkhobar, Saudi Arabia
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: Adults, older than 18. * Gender: all * Patient with confirmed diagnosis of H pylori for the first time * H pylori treatment naive patients * Welling to participate
Exclusion criteria
* Patients with failed H pylori eradication * Allergy to the used medications * Patients with other structural bowel diseases e.g. celiac disease, ischemic colitis, IBD, chronic diarrhea * General debilitating diseases e.g. decompensated cirrhosis, renal failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate | 2 weeks of continuous treatment, followed by 2 weeks of treatment and then testing again for presence\absence of the infection | How much the H pylori eradication rate following the treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile | up to 4 weeks (2 weeks active treatment and 2 weeks after treatment) | The side effects related to the used medications (triple therapy and lignin) |
Countries
Egypt
Outcome results
None listed