Helicobacter Pylori Infection, Peptic Ulcer
Conditions
Keywords
Helicobacter pylori, peptic ulcer, Lactobacillus johnsonii, immunoglobin Y
Brief summary
Challenges in the treatment of Helicobacter pylori (H. pylori) include increasing antimicrobial resistance and patient's low tolerance to some regimens. Lactobacillus johnsonii (L. johnsonii) and Immunoglobulin Y (IgY) have been shown to decrease the amount and activity of H. pylori in human stomach and can increase patient's tolerance. We conduct a single-center double-masked randomized controlled trial to evaluate the effectiveness of GastimunHp Plus (a product combining L. johnsonii and IgY) in improving the clearance of H. pylori after six to eight weeks of treatment and side effects of H. pylori treatment. H. pylori is tested by C13- or C14-urea breath test.
Interventions
DIETARY_SUPPLEMENTGastimunHp Plus
Each sachet contains 6mg of IgY and 50 mg of heat-killed Lactobacillus johnsonii No. 1088.
OTHERPlacebo
The placebo contains neither IgY nor L. johnsonii.
Sponsors
Institute of Gastroenterology and Hepatology, Vietnam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The investigational product (IP) is compared with a placebo. The IP and placebo are manufactured by the sponsor and then sent to the trial pharmacist. They are only different in a number in the package label, and only the sponsor knows which number is the IP and will call them product I and product II. This labelling is not revealed to the study team, the trial pharmacist, and the biostatistician. In the random number sequences generated by the biostatistician, the study numbers will be allocated to either product I or product II. The trial pharmacist is responsible for making product bags using study numbers and allocation given by the biostatistician. The product bags are transferred to the study team. In this way, the study team and patients are completely masked to the allocation.
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with gastritis, duodenitis, or peptic ulcer. * Tested positive with Helicobacter pylori using C13- or C14-urea breath test or urease test. * Indicated for Helicobacter pylori eradication.
Exclusion criteria
* Suspected malignant lesions. * Children under 10 years of age; pregnant or lactating women. * Allergic to chicken egg.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with negative urea breath test after 6-8 weeks | Six to eight weeks after recruitment | Patients tested negative with Helicobacter pylori using C13- or C14-urea breath test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with clinical improvement after 6-8 weeks | Six to eight weeks after recruitment | Symptom resolution evaluated clinically. |
| Proportion of patients with adverse effects | Six to eight weeks after recruitment | Any adverse effects that are deemed related to the investigational product. |
| Proportion of patients with improvement of lesions on endoscopy | Six to eight weeks after recruitment | Improvement of lesions detected on baseline on upper gastrointestinal endoscopy. Improvement was determined by expert's opinion. |
Countries
Vietnam
Outcome results
None listed