Lignin in Treatment of Helicobacter Pylori Infection

Zagazig University

Status and phase: Active, not recruiting; Phase 3

Conditions: HELICOBACTER PYLORI INFECTIONS

Treatments: Drug: Hydrolyzed Lignin; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07246681

KFSIRB200-784

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

70 participants in 2 patient groups, including a placebo group

Group I

Active Comparator group

Description:

This is the study group who will receive the standard triple (proton pump inhibitor, amoxicillin, clarithromycin) therapy plus the hydrolyzed lignin 400 mg

Treatment:

Drug: Hydrolyzed Lignin

Group II

Placebo Comparator group

Description:

This is the study group who will receive the standard triple therapy (proton pump inhibitor, amoxicillin, clarithromycin) plus the placebo identical in color, shape, and taste with the hydrolyzed lignin

Treatment:

Other: Placebo