Evaluation of the Efficacy and Safety of a Nutraceutical Containing Sodium Alginate, Sodium Bicarbonate, PEA, a Blend of Opuntia Ficus Indica, and Olea Europaea, Musa Paradisiaca, and Ginger in Patients With NERD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Symptom relief and quality of life (QoL)
研究概览
简要总结
Background: Non-erosive reflux disease (NERD) is a prevalent subtype of gastroesophageal reflux disease (GERD), often inadequately managed with proton pump inhibitors (PPIs) alone. Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts, has been proposed as an adjunctive therapy to enhance symptom relief and mucosal protection.
Objective: This study evaluates the efficacy and safety of a nutraceutical [Eolo®, Cristalfarma s.r.l. - Milan (IT)] in combination with PPIs or alone compared to PPIs therapy in patients with NERD.
Methods: A single-center, randomized, parallel-group study was conducted, enrolling 60 patients with NERD. Participants were randomized into three groups: (A) Eolo + half-dose PPIs for 12 weeks, (B) half-dose PPIs alone for 12 weeks, and (C) a control group receiving only half-dose PPIs for 24 weeks. After 12 weeks, groups A and B discontinued PPIs and continued with Eolo alone for an additional 12 weeks. Symptom relief and quality of life (QoL) were assessed using GERD-HRQOL and RSI questionnaires at baseline (T0), 12 weeks (T1), and 24 weeks (T2).
详细描述
This study evaluates the efficacy and safety of a nutraceutical in combination with PPIs or alone compared to PPIs therapy in patients with NERD.
A single-center, randomized, parallel-group study was conducted, enrolling 60 patients with NERD. Participants were randomized into three groups: (A) Eolo + half-dose PPIs for 12 weeks, (B) half-dose PPIs alone for 12 weeks, and (C) a control group receiving only half-dose PPIs for 24 weeks. After 12 weeks, groups A and B discontinued PPIs and continued with Eolo alone for an additional 12 weeks. Symptom relief and quality of life (QoL) were assessed using GERD-HRQOL and RSI questionnaires at baseline (T0), 12 weeks (T1), and 24 weeks (T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants were eligible for the study if they met the following criteria:
- •Had a diagnosis of non-erosive reflux disease (NERD) with typical reflux symptoms persisting for at least three months and occurring at least three times per week in the month preceding the study screening visit.
- •Were aged between 18 and 80 years.
- •Had been on therapy with a proton pump inhibitor (PPI) at a standard dosage for at least six weeks (40 mg pantoprazole/esomeprazole, 30 mg lansoprazole, or 20 mg omeprazole/rabeprazole).
- •Had a diagnosis of NERD confirmed by the absence of macroscopic lesions of the distal esophageal mucosa on endoscopy performed within six months before the screening visit and a positive score on a validated questionnaire (Reflux Disease Questionnaire, RDQ Score ≥ 8).
排除标准
- •Patients were excluded if they had any of the following conditions:
- •Erosive esophagitis or Barrett's esophagus.
- •Gastric or duodenal ulcer.
- •History of major gastric or gastrointestinal surgery.
- •Atopy or food intolerances.
- •Thyroid disease.
- •Diabetes or metabolic syndrome.
- •Pregnancy or breastfeeding
研究组 & 干预措施
Group C
half-dose PPIs for 24 weeks
干预措施: EOLO (Dietary Supplement)
Group B
Patients receiving half-dose PPIs alone for 12 weeks, then Eolo alone for 12 additional weeks.
干预措施: PPI (proton pump inhibitor) (Drug)
Group A
Patients receiving Eolo 24 we
干预措施: PPI (proton pump inhibitor) (Drug)
结局指标
主要结局
Symptom relief and quality of life (QoL)
时间窗: Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-50; higher scores indicate worse quality of life.
GERD-HRQOL
次要结局
- RSI (Reflux Symptom Index)(Baseline (T0), Week 12 (T1), and Week 24 (T2). Score range 0-45; higher scores indicate worse symptoms.)
研究者
Carlo Calabrese
Clinical Professor
University of Bologna