Functional Dyspepsia, Helicobacter Pylori Infection
Conditions
Keywords
Functional Dyspepsia, Helicobacter Pylori eradication, Quality of Life, Dyspeptic Symptoms
Brief summary
Helicobacter pylori eradication and its impact on symptoms in patients with non-ulcer dyspepsia remain controversial . Many studies have examined the effect of H. pylori eradication on dyspeptic symptoms, but the results have been conflicting and inconclusive, with as many studies yielding positive as negative results. Some studies have shown a significant (although weak) symptomatic improvement after H. pylori eradication, and while other yielding negative results. A recent Cochrane review has comprehensively demonstrated that H.pylori eradication therapy has a small but statistically significant effect in H.pylori positive non-ulcer dyspepsia. An economic model suggests this modest benefit may still be cost effective . However it is difficult to reconcile these results in areas with very high prevalence of H. pylori infection such as Pakistan since no such studies have been conducted in developing countries. The investigators hypothesize that eradication of Helicobacter pylori (H. pylori) leads to a sustained improvement in symptoms of patients diagnosed with H. pylori associated functional (non-ulcer) dyspepsia.
Interventions
DRUGOmeprazole + Clarithromycin + Amoxycillin
Omeprazole 20mg BID for 1 week along with Clarithromycin 500mg BD and Amoxycillin 1g BD for 1 week
DRUGOmeprazole + placebo antibiotics
omeprazole 20 mg bid for 1 week along with placebo antibiotics for 1 week
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ambulatory adult males and non-pregnant females. * Dyspeptic symptoms for at least 3 months. * Normal endoscopic findings. * H. Pylori positive on testing.
Exclusion criteria
* Patients with erosive and non erosive esophagitis. * Barrette's esophagus. * Duodenal Ulcer, Gastric Ulcer or gastric erosions. * Patients with known sensitivity to antibiotics. * Patients with severe concomitant systemic disease. * Patients with upper GI surgery except cholecystectomy. * Females with pregnancy or breast-feeding. * Malignancy * Alarm symptoms such as bleeding per rectum, hematemesis, and severe weight loss.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Dyspeptic Symptoms after eradication of Helicobacter Pylori in Patients with Functional Dyspepsia | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether eradication of Helicobacter Pylori improves the quality of life in patients with Functional Dyspepsia i.Quality of life (QoL) assessment on the basis of SF-36. | 1 year |
Countries
Pakistan
Outcome results
None listed