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Lignin in Treatment of Helicobacter Pylori Infection

NCT07246681 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-11-24

No results posted yet for this study

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

Conditions

  • HELICOBACTER PYLORI INFECTIONS

Interventions

DRUG

Hydrolyzed Lignin

The drug will be supplied randomly to the group I

OTHER

Placebo

Will be supplied randomly to Group II

Sponsors & Collaborators

  • EVERGREEN MEDICAL COMPANY

    collaborator UNKNOWN

  • Kafrelsheikh University

    collaborator OTHER

  • Al-Azhar University, Egypt

    collaborator UNKNOWN

  • Ain Shams University, Egypt

    collaborator UNKNOWN

  • Security Forces Hospital Riyadh, Saudi Arabia

    collaborator UNKNOWN

  • Alyousif Hospital, Alkhobar, Saudi Arabia

    collaborator UNKNOWN

  • Zagazig University

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-02-15
Completion
2026-03-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07246681 on ClinicalTrials.gov