A comparison of triple therapy drug regimen duration for the eradication of Helicobacter pylori in adults attending a Nairobi gastroenterology clinic

• Register: PACTR
• Last refreshed on: 29 April 2013
• Main ID: PACTR201211000440194
• Date of registration: 21/10/2012
• Public title: A comparison of triple therapy drug regimen duration for the eradication of Helicobacter pylori in adults attending a Nairobi gastroenterology clinic
• Scientific title: A comparison of triple therapy drug regimen duration for the eradication of Helicobacter pylori in adults attending a Nairobi gastroenterology clinic; a randomized clinical trial
• Date of first enrolment: 2007-12-03
• Target sample size: 150
• Recruitment status: Completed: recruitment & data analysis complete
• URL: HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201211000440194
• Study type: interventional
• Study design: Factorial: participants randomly allocated to either no,one,some or all interventions simultaneously,; Randomised,; Simple randomisation using a randomisation table created by a computer software program,; sealed opaque envelopes,

Countries of recruitment

South Africa

Contacts

• Name: Samuel Kariuki
• Affiliation: CMR Director

• Name: Ciira Kiiyukia
• Affiliation: Lecturer

Key inclusion & exclusion criteria

Inclusion criteria: Presence of at least two of the following symptoms; upper abdominal pain or discomfort, bloating, nausea, vomiting or early satiety.

Persistent or recurrent symptoms occurring at least three times per week during six or more months in the year(s) preceding the study.

Age 18 years and above.

Written informed consent.

H. pylori positive on rapid urease test.

Exclusion criteria: Previous treatment for H. pylori less than 4 weeks prior to endoscopy.

Allergy to penicillins or macrolides.

Significant liver or kidney disease.

Severe cardiac or pulmonary disease.

Suspected or confirmed malignancy.

Concurrent reflux oesophagitis.

Active upper gastrointestinal bleeding.

History of gastric surgery except uncomplicated appendectomy, cholecystectomy or hernia repair.

Pregnancy or breast-feeding.

Patients using antibiotics in the month before inclusion, bismuth-containing compounds during the 3 months before inclusion, or Proton pump inhibitors, H2 receptor antagonists, misoprostol or sucralfate in the 2 weeks before the pre-entry endoscopy.

Patients receiving regular treatment with Non-steroidal analgesics more than or equal to 5 days a week, for at least 2 weeks during the month before the start of the study.


Age minimum: 18 Year
Age maximum: 85 Year
Gender: Both

Health Condition(s) or Problem(s) studied

Helicobacter pylori gastritis

Primary Outcome(s)

Eradication of H. pylori infection

Secondary Outcome(s)

Efficacy of H. pylori drug regime

Prevalence of H. pylori infection in patients undergoing endoscopy

Secondary ID(s)

SSC protocol no. 1317

Source(s) of Monetary Support

Soraya P. Mavumba

Secondary Sponsor(s)

Jomo Kenyatta University of Agricuture and Technology

KEMRI