Cureus · 2025
Evaluation of the Safety and Efficacy of Ganga Water-Phage Therapy Plus Standard Medical Therapy Compared to Standard Medical Therapy Alone for Helicobacter pylori-Related Dyspepsia: A Randomized Controlled Trial.
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Verma Virendra, Devi Archana, Jhunjhunwala Bharat, Kumar Ravi, Singh Jitendra, Pandey Mahesh Chandra, Patwa Ajay
Аннотация
BACKGROUND: Dyspepsia is a prevalent gastrointestinal condition in India, commonly linked to Helicobacter pylori infection. Standard medical therapy (SMT) with proton-pump inhibitors and antibiotics shows declining success due to rising antimicrobial resistance. Ganga water-phage therapy (GWPT), rich in natural bacteriophages with reported antibacterial effects, may offer a culturally relevant adjuvant strategy.
OBJECTIVE: This study aimed to evaluate the safety and efficacy of GWPT combined with SMT versus SMT alone in H. pylori-related dyspepsia.
METHODS: This prospective, randomized, controlled, open-label clinical trial was conducted between March 2025 and July 2025 at two tertiary-care centers in northern India: Rajarshi Dashrath Autonomous State Medical College, Ayodhya, and King George's Medical University (KGMU), Lucknow. In this randomized controlled trial (CTRI/2024/07/070007), 50 adults aged 18-65 years with confirmed H. pylori infection (rapid urease test positive) were randomized to receive either SMT alone (n = 24) or SMT plus GWPT (n = 26) for 14 days. Outcomes included H. pylori eradication at two weeks, symptom improvement using the Gastrointestinal Distress Scale (GOS), quality of life via SF-36, and safety assessment. Statistical analyses used t-tests, Mann-Whitney U, chi-square, and Wilcoxon signed-rank tests with significance set at p < 0.05.
RESULTS: Eradication rates were 66.7 % for SMT and 69.2 % for SMT + GWPT (p = 1.000). Both groups improved significantly in symptom and quality-of-life measures, with numerically greater gains in the GWPT arm. Adverse events were mild (abdominal discomfort, nausea, gastritis, and belching); no serious toxicity occurred.
CONCLUSION: GWPT, when added to SMT, marginally enhances H. pylori eradication. It confers greater improvements in symptoms and quality of life, with good safety and tolerability. GWPT may serve as a culturally acceptable adjuvant therapy in dyspepsia management. Larger multicenter studies with longer follow-up and antimicrobial resistance profiling are warranted.
OBJECTIVE: This study aimed to evaluate the safety and efficacy of GWPT combined with SMT versus SMT alone in H. pylori-related dyspepsia.
METHODS: This prospective, randomized, controlled, open-label clinical trial was conducted between March 2025 and July 2025 at two tertiary-care centers in northern India: Rajarshi Dashrath Autonomous State Medical College, Ayodhya, and King George's Medical University (KGMU), Lucknow. In this randomized controlled trial (CTRI/2024/07/070007), 50 adults aged 18-65 years with confirmed H. pylori infection (rapid urease test positive) were randomized to receive either SMT alone (n = 24) or SMT plus GWPT (n = 26) for 14 days. Outcomes included H. pylori eradication at two weeks, symptom improvement using the Gastrointestinal Distress Scale (GOS), quality of life via SF-36, and safety assessment. Statistical analyses used t-tests, Mann-Whitney U, chi-square, and Wilcoxon signed-rank tests with significance set at p < 0.05.
RESULTS: Eradication rates were 66.7 % for SMT and 69.2 % for SMT + GWPT (p = 1.000). Both groups improved significantly in symptom and quality-of-life measures, with numerically greater gains in the GWPT arm. Adverse events were mild (abdominal discomfort, nausea, gastritis, and belching); no serious toxicity occurred.
CONCLUSION: GWPT, when added to SMT, marginally enhances H. pylori eradication. It confers greater improvements in symptoms and quality of life, with good safety and tolerability. GWPT may serve as a culturally acceptable adjuvant therapy in dyspepsia management. Larger multicenter studies with longer follow-up and antimicrobial resistance profiling are warranted.