Health Condition 1: - Health Condition 2: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Ganga Water Phage Therapy plus Standard Medical Therapy: GWPT (30 ml packaged in a bottle) plus SMT three times a day for 14 days.
Control Intervention1: Standard Medical Therapy only:
Sponsors
Motilal Bhimraj Charity Trust
Eligibility
Inclusion criteria
Inclusion criteria: 1. Symptoms consistent with functional dyspepsia patients of at least two weeks’ duration (defined as recurrent pain or discomfort centered in the upper abdomen, often with a relation to meals). 2. Positive for H. pylori by Rapid Urease Test. 3. Male and female patients age ?18 years and ? 70 years. 4. Agree to refrain from consuming alcohol from 1 week prior to screening. 5. Agree to refrain from taking antacids from screening through day 15 and for at least 24 hours prior to test of detection and cure. 6. Agree to refrain from taking H2 blockers at least 24 hours prior to screening RUT(Rapid Urease Test) and at least 24 hours prior to test of detection and cure. 7. Agree to refrain from taking sucralfate, bismuth containing medications such as Pepto-Bismol TM or other proton pump inhibitors (PPIs) from two weeks prior to screening through test of detection and cure. 8. Be able to give written informed consent. 9. Be in generally good health as determined by the investigator OR Have mild gastrointestinal discomfort, such as mild indigestion. 10. No history of H. pylori eradication.
Exclusion criteria
Exclusion criteria: 1. Symptoms/signs of unexplained anemia [iron deficiency], melena/hematemesis, anorexia, dysphagia, jaundice, weight loss). 2. Have received prior H. pylori eradication therapy. 3. Use of any proton pump inhibitors (PPIs) within the 2 weeks immediately prior to screening RUT (Rapid Urease Test). 4. Presence of more than two active gastric and/or duodenal ulcers. 5. History of gastric outlet obstruction; or hyper secretory state (e.g., Zollinger Ellison Syndrome); 6. Have an active gastrointestinal disorder, concomitant end stage organ disease or History of previous gastrointestinal surgery, esophageal or gastric surgery, except for simple closure of perforated ulcer. 7. History of gastric cancer 8. Positive screening laboratory results for human immunodeficiency virus (HIV) antibody (HIV1 or HIV2), or hepatitis B surface antigen (HBs Ag), or hepatitis C antibody (HCV Ab).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety and Efficacy of H. pylori eradication treatment with Ganga water will be done by calculating the proportion of participants developing any adverse reaction and reaching H. pylori eradication, as per clinical and laboratory findings. 2. Detection of uncomplicated gastritis, ulcer, or metaplasia or dysplasia or frank cancer in histopathological examination (HPE) before and 2 weeks after Ganga water phage therapy.Timepoint: 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Frequency and severity of dyspeptic symptoms from baseline evaluated by GOS scale at the end of eradication treatment score ranges 0 – No Problem to 5 – Severe Problem) at the end of eradication treatment. 2. Health-related quality of life (HR-QoL): Evaluated by the administration of the 36-Item Short Form Survey Instrument (SF-36; score ranges 0 – worst possible health to 100 – best possible health) at the end of eradication treatment.Timepoint: 2 weeks | — |
Countries
India
Contacts
Public ContactDr Virendra Verma
Rajarshi Dashrath Autonomous State Medical College Ayodhya
Outcome results
None listed