Efficacy Assessment of Probiotic Supplementation as an Adjunct to Standard Antibiotic Therapy in Patients with Helicobacter pylori Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This is a randomized, controlled clinical trial designed to assess the efficacy and safety of an adjunctive probiotic therapy in patients with Helicobacter pylori infection. A total of 60 eligible patients (as per inclusion and exclusion criteria) will be enrolled and randomly assigned in a 1:1 ratio using a computer-generated sequence to one of two treatment groups. For eradication of H. pylori infection, the control group (n = 30) will receive only the standard antibiotic and PPI regimen, while the intervention group (n = 30) will receive the same standard antibiotic and PPI treatment supplemented with a daily probiotic capsule for 60 days. The probiotic capsule contains a total of 45×10^9 Colony Forming Units (CFU) of a multi-strain formulation including Lactobacillus paracasei DSM 24733*, Lactobacillus plantarum* DSM 24730*, Lactobacillus acidophilus* DSM 24735*, Lactobacillus delbrueckii subsp. bulgaricus* DSM 24734*, Bifidobacterium longum* DSM 24736*, Bifidobacterium infantis* DSM 24737*, Bifidobacterium breve* DSM 24732*,*and Streptococcus thermophilus DSM 24731. Throughout the study, participants will be closely monitored, with adherence assessed via the Simplified Medication Adherence Questionnaire (SMAQ) and Adverse Event Diary during the entire study. In addition, formal assessments will be performed at baseline (Day 0) and at the end of follow-up on Day 61. These assessments will include the Gastrointestinal Symptom Rating Scale (GSRS), UGI, Complete Blood Count (CBC), C-Reactive Protein (CRP), and Stool Antigen Test levels to compare outcomes between the two groups.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants must be between 18 and 65 years of age, inclusive.
- •Diagnosis of Helicobacter pylori infection confirmed by a positive Rapid Urease Test (RUT) or histological findings from endoscopic biopsy suggestive of H.
- •pylori presence.
- •Both male and female participants are eligible for inclusion.
- •Patients will have a similar type of antibiotic and PPI therapy throughout the study.
排除标准
- •Current or recent (within 45 days) antibiotic therapy.
- •Presence of any co-existing chronic gastrointestinal (GI) disorder, or significant hepatic, renal, or cardiac disease.
- •Diagnosis of any form of cancer.
- •Current use of proton pump inhibitors (PPIs), H2-receptor antagonists, antibiotics, probiotic supplements or medications known to interfere with H.
- •pylori eradication regimen.
- •History of prior gastrointestinal surgery.
- •Women who are pregnant or breastfeeding.
- •Ongoing use of hormonal drugs.
- •Known allergy or hypersensitivity to any of the antibiotics planned for use in the study protocol.
研究者
Vidhi Shah
Gujarat University