Lignin in Treatment of Helicobacter Pylori Infection

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: HELICOBACTER PYLORI INFECTIONS
• Intervention / Treatment: Drug: Hydrolyzed Lignin; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Kafr el-Sheikh Governorate
    • Kafr ash Shaykh, Kafr el-Sheikh Governorate, Egypt, 33726
      • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; This is the study group who will receive the standard triple (proton pump inhibitor, amoxicillin, clarithromycin) therapy plus the hydrolyzed lignin 400 mg	Drug: Hydrolyzed Lignin; The drug will be supplied randomly to the group I
Placebo Comparator: Group II; 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	Other: Placebo; Will be supplied randomly to Group II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate	How much the H pylori eradication rate following the treatment	2 weeks of continuous treatment, followed by 2 weeks of treatment and then testing again for presence\absence of the infection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety profile	The side effects related to the used medications (triple therapy and lignin)	up to 4 weeks (2 weeks active treatment and 2 weeks after treatment)

Collaborators and Investigators

• Sponsor: Zagazig University
• Collaborators: EVERGREEN MEDICAL COMPANY; Kafreksheikh University, Egypt; Al-Azhar University, Egypt; Ain Shams University, Egypt; Security Forces Hospital Riyadh, Saudi Arabia; Alyousif Hospital, Alkhobar, Saudi Arabia

Publications and helpful links

General Publications

• 1- Öztekin M, Yılmaz B, Ağagündüz D, Capasso R. Overview of Helicobacter pylori Infection: Clinical Features, Treatment, and Nutritional Aspects. Diseases. 2021 Sep 23;9(4):66. doi: 10.3390/diseases9040066. PMID: 34698140; PMCID: PMC8544542. 2- Malfertheiner P, Megraud F, Rokkas T, Gisbert JP, Liou JM, Schulz C, Gasbarrini A, Hunt RH, Leja M, O'Morain C, Rugge M, Suerbaum S, Tilg H, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study group. Management of Helicobacter pylori infection: the Maastricht VI/Florence consensus report. Gut. 2022 Aug 8:gutjnl-2022-327745. doi: 10.1136/gutjnl-2022-327745. Epub ahead of print. PMID: 35944925. 3- Maldonado-Carmona N, Marchand G, Villandier N, Ouk TS, Pereira MM, Calvete MJF, Calliste CA, Żak A, Piksa M, Pawlik KJ, Matczyszyn K, Leroy-Lhez S. Porphyrin-Loaded Lignin Nanoparticles Against Bacteria: A Photodynamic Antimicrobial Chemotherapy Application. Front Microbiol. 2020 Nov 17;11:606185. 4- Sugiarto S, Leow Y, Tan CL, Wang G, Kai D. How far is Lignin from being a biomedical material? Bioact Mater. 2021 Jun 26;8:71-94. doi: 10.1016/j.bioactmat.2021.06.023. 5- Syed Waqas Ali Shah, Qi Xu, Muhammad Wajid Ullah, Zahoor, Sivasamy Sethupathy, Gabriel Murillo Morales, Jianzhong Sun, Daochen Zhu, Lignin-based additive materials: A review of current status, challenges, and future perspectives, Additive Manufacturing, Volume 74, 2023, 103711, ISSN 2214-8604, https://doi.org/10.1016/j.addma.2023.103711.(https://www.sciencedirect.com/science/article/pi). 6- Hunt R., Xiao S., Megraud F., Leon-Barua R., Bazzoli F., Van Der Merwe S., et al. (2011) Helicobacter pylori in developing countries. World Gastroenterology Organisation Global Guideline. J Gastrointestin Liver Dis 20: 299-304. 7- Alsohaibani F, Peedikayil M, Alshahrani A, Somily A, Alsulaiman R, Azzam N, Almadi M. Practice guidelines for the management of Helicobacter pylori infection: The Saudi H. pylori Working Group recommendations. Saudi J Gastroenterol. 2023 Nov-

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2025
• Primary Completion (Estimated): February 15, 2026
• Study Completion (Estimated): March 15, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Eradication; Helicobacter Pylori; Side effects; Lignin
• Other Study ID Numbers: KFSIRB200-784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No