HELICOBACTER PYLORI INFECTIONSPhase 3NCT07246681
Lignin in Treatment of Helicobacter Pylori Infection
A Phase 3 study testing Hydrolyzed Lignin in people with HELICOBACTER PYLORI INFECTIONS, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Hydrolyzed Lignin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Oct 2025to 15 Sep 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Kafrelsheikh University
Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33726
About this study
Official title: 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.
Read more
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
- Being tested
- Hydrolyzed Lignin, Placebo
- Keywords
- Helicobacter Pylori, Lignin, Eradication, Side effects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed LigninDrug
The drug will be supplied randomly to the group I
PlaceboOther
Will be supplied randomly to Group II
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
How much the H pylori eradication rate following the treatment
Measured: 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
The side effects related to the used medications (triple therapy and lignin)
Measured: up to 4 weeks (2 weeks active treatment and 2 weeks after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start31 Oct 2025
- Primary completion15 Aug 2026
- Study completion15 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Collaborators
- EVERGREEN MEDICAL COMPANY, Kafrelsheikh University, Al-Azhar University, Ain Shams University, Security Forces Hospital Riyadh, Saudi Arabia, Alyousif Hospital, Alkhobar, Saudi Arabia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246681
- Sponsor's protocol ID
- KFSIRB200-784
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Lignin in Treatment of Helicobacter Pylori Infection: A Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07246681
- Acronym / sponsor ID
- KFSIRB200-784
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Keywords
- Helicobacter Pylori, Lignin, Eradication, Side effects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Collaborators
- EVERGREEN MEDICAL COMPANY, Kafrelsheikh University, Al-Azhar University, Ain Shams University, Security Forces Hospital Riyadh, Saudi Arabia, Alyousif Hospital, Alkhobar, Saudi Arabia
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Sep 2026 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Hydrolyzed LigninThis is the study group who will receive the standard triple (proton pump inhibitor, amoxicillin, clarithromycin) therapy plus the hydrolyzed lignin 400 mg |
| Group II | Placebo comparator | Other: PlaceboThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrolyzed LigninThe drug will be supplied randomly to the group I | Drug | Group I |
| PlaceboWill be supplied randomly to Group II | Other | Group II |
Primary outcome
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
1 secondary outcome
Safety profile
Time frame: up to 4 weeks (2 weeks active treatment and 2 weeks after treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Results publication1- 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-
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydrolyzed Lignin in people with HELICOBACTER PYLORI INFECTIONS, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07246681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.