Helicobacter Pylori Eradication in Functional Dyspepsia

NCT04697641 | Completed

• 1 other identifier: EC/07/17/1202
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to study benefit of eradicating Helicobacter Pylori in patients with functional dyspepsia as compared to symptomatic treatment only. Helicobacter pylori positive patients with Functional Dyspepsia will be divided into two study groups, one will receive Helicobacter pylori eradication therapy and other will receive symptomatic treatment. Symptom relief based on Likert scale will be compared in both groups.

Conditions

Dyspepsia; Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Functional Dyspepsia; Triple Drug Regimen; Global Overall Scale; Epigastric Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Treatment Success

  Treatment success defined as absence of symptoms or minimal symptoms (GOS score \<3) with GOS reduction by at least 2, 6 months after treatment.

  Six months after the completion of intervention

Secondary Outcomes (3)

• Prevalence of Helicobacter pylori infection in Functional Dyspepsia

  At enrolment

• Efficacy of Helicobacter pylori eradication therapy

  Four weeks after the completion of intervention

• Rate of Helicobacter pylori reinfection

  Six months after the completion of intervention

Study Arms (2)

Helicobacter pylori eradication therapy Group

EXPERIMENTAL

Patients with Functional Dyspepsia receiving two week course of triple drug regimen for H pylori eradication followed by six weeks of proton pump inhibitors

Drug: Clarithromycin 500mg; Drug: Amoxicillin 1000 MG; Drug: Pantoprazole 40mg

Symptomatic treatment group

ACTIVE COMPARATOR

Patients with Functional Dyspepsia receiving symptomatic therapy with proton pump inhibitors or gastric prokinetics

Drug: Pantoprazole 40mg; Drug: Levosulpiride; Drug: Acotiamide; Drug: Itopride

Interventions

Clarithromycin 500mg DRUG

Clarithromycin 500 mg twice a day for two weeks

Helicobacter pylori eradication therapy Group

Amoxicillin 1000 MG DRUG

Amoxicillin 1000mg twice a day for two weeks

Helicobacter pylori eradication therapy Group

Pantoprazole 40mg DRUG

Pantoprazole 40 mg or equivalent for eight weeks

Helicobacter pylori eradication therapy Group; Symptomatic treatment group

Levosulpiride DRUG

Levosulpiride 25 mg as and when required before meals

Symptomatic treatment group

Acotiamide DRUG

Acotiamide 100mg as when required before meals

Symptomatic treatment group

Itopride DRUG

Itopride 50mg as when required before meals

Symptomatic treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Patients fulfilling the ROME-IV criteria of Functional Dyspepsia
• Signed informed consent.

You may not qualify if:

• Pregnant and lactating females
• Patients with predominant symptoms of heartburn or irritable bowel syndrome; alarm symptoms; history of peptic ulcer, upper gastrointestinal tract surgery, or biliary colic
• Previous treatment for eradication of H pylori.
• Known allergies to study medication or alcohol or drug abuse.
• Use of antibiotics or bismuth during the 4 weeks before enrolment, proton pump inhibitors during the 2 weeks before enrolment, or treatment with histamine-2 receptor blockers in the week before enrolment will not be permitted.
• Patients unable to answer the study questionnaires.
• Patients unwilling or unable to provide consent.
• Patient on HIV/AIDS medications, blood thinners, clopidogrel, cyclosporine, digoxin, iron supplements, fluconazole or ketoconazole, probenecid, rifabutin, sildenafil, tacrolimus, theophylline, sulfa drugs, cholesterol-lowering medicines, heart rhythm medications, sedatives, seizure medications, or tetracycline antibiotics.

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Department of Gastroenterology & Hepatology, Sir Ganga Ram Hospital

New Delhi, 110060, India

Location

Related Publications (1)

• Padole P, Ranjan P, Sachdeva M, Kumar M. Role of Helicobacter pylori eradication in patients with functional dyspepsia. Indian J Gastroenterol. 2021 Oct;40(5):492-501. doi: 10.1007/s12664-021-01195-3. Epub 2021 Oct 27.

  PMID: 34708338 DERIVED

MeSH Terms

Conditions

Dyspepsia

Interventions

Clarithromycin; Amoxicillin; Pantoprazole; levosulpiride; Z 338; itopride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Two study groups receiving two different treatment strategies

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 6, 2021
• Study Start: September 1, 2017
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: January 14, 2021

Record last verified: 2021-01

Locations

IN (1)