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NCT Number: NCT07246681

Lignin in Treatment of Helicobacter Pylori Infection

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HELICOBACTER PYLORI INFECTIONS

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33726, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydrolyzed Lignin

Drug

The drug will be supplied randomly to the group I

Placebo

Other

Will be supplied randomly to Group II

Primary outcomes

  1. Eradication rate

    Time frame: 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 outcomes

  1. Safety profile

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Collaborators

  • Ain Shams University, Egypt
  • Al-Azhar University, Egypt
  • Alyousif Hospital, Alkhobar, Saudi Arabia
  • EVERGREEN MEDICAL COMPANY
  • Kafrelsheikh University
  • Security Forces Hospital Riyadh, Saudi Arabia

Registry information

Official study title

Role of Lignin in Treatment of Helicobacter Pylori Infection: A Double-blind Placebo-controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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