Probiotic for eradication of helicobacter pylori

Phase 2

Conditions: Helicobacter pylori infection.
Helicobacter pylori [H.pylori] as the cause of diseases classified

Registration Number: IRCT201209041579N4

Lead Sponsor: Vice Chancellor for Research, Isfahan University of Medical Sciences

Brief Summary: BACKGROUND: Evidence has shown benefits of single-strain probiotics for Helicobacter pylori eradication. We investigated the effects of adding a multistrain probiotic compound on bismuth-containing quadruple therapy for H. pylori infection. MATERIALS AND METHODS: Adult patients with peptic ulcer disease and confirmed H. pylori infection (n = 180) were randomized to receive bismuth-containing quadruple therapy (omeprazole, bismuth subcitrate, amoxicillin, and clarithromycin) plus a probiotic compound or placebo for 2 weeks. The probiotic compound contained seven bacterial species including Lactobacillus and Bifidobacterium strains and Streptococcus thermophiles. Eradication of H. pylori was assessed 4 weeks after medication by (13) C urea breath test. Other outcomes were dyspepsia symptoms, therapy-related adverse effects, and patient's tolerance. RESULTS: Eighty-four patients in the probiotic and 86 in the placebo group completed the trial. With per-protocol (intention to treat) analysis, H. pylori was eradicated in 82.1% (76.6%) of the probiotic and 84.8% (81.1%) of the placebo group, p = .392 (0.292). Symptoms were significantly improved with similar trends in both groups. Regarding the adverse effects, diarrhea was less frequent (2.2 vs 11.1%, p = .016), while abdominal pain was more frequent (10 vs 2.2%, p = .029) in the probiotic group. The two groups were similar in treatment tolerance (p = .851). CONCLUSIONS: In overall, our studied multistrain probiotic compound has not beneficial effects in the treatment of H. pylori infection. It might be related to the low dosage of our probiotic regimen and/or high frequency of upper gastrointestinal adverse effects which in turn could decrease the eradication efficacy.

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 180

Inclusion Criteria

- Age 18 to 65 years,
- Having peptic ulcer disease on upper gastrointestinal endoscopy,
- Having helicobacter pylori infection diagnosed by rapid urease test or urea breath test,
- Willingness to participate in the study,
- Not having Zollinger Ellison Syndrome, cancers of the digestive tract, liver or kidney diseases, other infections may require antibiotics, immune deficiency disease,
- No history of upper gastrointestinal surgery,
- No history of the eradication of Helicobacter pylori, or the use of Proton Pomp Inhibitors, antibiotics, and probiotics (synthetic or natural) over the past 4 weeks,
- No contraindications for using any dug of the quadruple therapy.

Exclusion criteria:
- Not taking medications regularly, (not taking >= 20% of all the prescribed capsules),
- Severe side effects of the quadruple therapy.

Exclusion Criteria

Not provided