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| Name | Class |
|---|---|
| EVERGREEN MEDICAL COMPANY | UNKNOWN |
| Kafrelsheikh University | OTHER |
| Al-Azhar University, Egypt | UNKNOWN |
| Ain Shams University, Egypt |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrolyzed Lignin | Drug | The drug will be supplied randomly to the group I |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kafrelsheikh University | Kafr ash Shaykh | Kafr el-Sheikh Governorate | 33726 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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- |
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| UNKNOWN |
| Security Forces Hospital Riyadh, Saudi Arabia | UNKNOWN |
| Alyousif Hospital, Alkhobar, Saudi Arabia | UNKNOWN |
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| Placebo |
| Other |
Will be supplied randomly to Group II |
|