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.

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.