Ganga Water Phage Therapy in helicobacter pylori-related dyspepsia

Phase 2

Conditions: Health Condition 1: - Health Condition 2: K928- Other specified diseases of the digestive system

Registration Number: CTRI/2024/07/070007

Lead Sponsor: Motilal Bhimraj Charity Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

Have mild gastrointestinal discomfort, such as mild indigestion.

10. No history of H. pylori eradication.

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br/ ><br>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 Outcome Measures

Name	Time	Method
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. <br/ ><br>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