Evaluation of the Safety & Efficacy of Ganga Water Phage Therapy (GWPT) plus Standard Medical Therapy (SMT) as compared to Standard Medical Therapy (SMT) alone for Helicobacter pylori-related Dyspepsia: A Randomized Control Trial. - None

Motilal Bhimraj Charity Trust0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•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
•Have mild gastrointestinal discomfort, such as mild indigestion.
•10. No history of H. pylori eradication.

•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).

发起方

Motilal Bhimraj Charity Trust