Lignin in Treatment of Helicobacter Pylori Infection

NCT07246681 | Active Not Recruiting Phase 3 DMC

• 1 other identifier: KFSIRB200-784
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter Pylori; Lignin; Eradication; Side effects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety profile

  up to 4 weeks (2 weeks active treatment and 2 weeks after treatment)

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

Group II

PLACEBO COMPARATOR

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

Interventions

Hydrolyzed Lignin DRUG

The drug will be supplied randomly to the group I

Group I

Placebo OTHER

Will be supplied randomly to Group II

Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Kafrelsheikh University

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

Location

Related Publications (1)

• 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-

  RESULT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: October 31, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)