Randomized Double-Blind Interventional Study To Evaluate The Efficacy Of Galactol In Patients With Celiac Disease And Functional Abdominal Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Primary endpoint
研究概览
简要总结
The aim of this randomized, double-blind, placebo-controlled interventional study is to evaluate the efficacy of Galactol® in adult patients aged 18 to 70 years with celiac disease and functional abdominal bloating.
The main question the study aims to answer is:
Does Galactol® improve the overall well-being of patients with celiac disease and functional abdominal bloating? Researchers will compare a group taking Galactol® with a group taking a placebo to determine whether the treatment leads to an improvement in overall well-being and gastrointestinal symptoms.
Participants will: be randomly assigned to either the Galactol® group or the placebo group; take the assigned product for 30 days; complete questionnaires and assessment scales to evaluate overall well-being, gastrointestinal symptoms, quality of life, mental health, and adherence to a gluten-free diet; undergo 5 mL blood draws before and after treatment to measure IL-10 and TNF-α levels; attend an initial visit and a visit after 30 days of treatment, during which tolerability, compliance, and any adverse events will also be assessed.
详细描述
The study is designed as a non-pharmacological interventional clinical investigation aimed at evaluating the effect of a food supplement on overall well-being and gastrointestinal symptoms in adult subjects with celiac disease (CD) and functional abdominal bloating. The study design involves a comparison between the intake of Galactol® and a placebo, with treatment effects assessed using clinical tools and validated questionnaires, as well as through the measurement of specific blood biomarkers.
The primary objective is to determine whether the intervention results in an improvement in patients' perceived overall well-being over a 30-day period compared with baseline, and whether any such improvement differs from that observed in subjects receiving the placebo.
A total of 50 adult patients are expected to be enrolled. Participants will be randomly assigned to the treatments in a 1:1 ratio and will therefore be allocated to two groups of comparable size: intervention group, receiving treatment with Galactol®; placebo group, receiving the placebo product. The intervention group will receive Galactol®, a food supplement containing, per tablet, 100 mg of Tolerase® G, 600 GalU of α-galactosidase, and 4,500 ALU of β-galactosidase. The treatment will be administered for 30 days as follows: 2 tablets at the beginning of lunch; 2 tablets at the beginning of dinner.
The control group will receive a placebo with characteristics corresponding to those of the active product and with identical administration schedules and timing. The use of a placebo is intended, as far as possible, to distinguish the specific effect of the supplement from non-specific effects associated with participation in the study, the attention received from healthcare staff, and participants' expectations.
Each participant will take part in three main study visits: a screening visit, a baseline visit and a visit at the end of the treatment period. Screening visit (T0):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have provided written informed consent
- •Age: 18-70 years
- •Patients with celiac disease and functional abdominal bloating
排除标准
- •Women who are pregnant or breastfeeding
- •Patients intolerant to one or more components of Galactol®/placebo
- •Patients allergic to one or more components of Galactol®/placebo
研究组 & 干预措施
Galactol Group
Galactol group, receiving treatment with Galactol®
干预措施: Galactol® (Dietary Supplement)
Placebo group
Placebo group, receiving the placebo product
干预措施: Placebo (Other)
结局指标
主要结局
Primary endpoint
时间窗: 30 days (T1 to T2)
The primary endpoint is the quantitative change in the patient's overall well-being, assessed using a Visual Analogue Scale (VAS) ranging from 0 to 10, with higher scores indicating better well-being. The change in VAS score will be calculated as the difference between the post-treatment visit (T2) and the baseline visit (T1) (T2-T1) in both groups. The change in VAS score will be compared between the treatment group and the placebo group.
次要结局
- Abdominal pain(30 days (T1 to T2))
- Abdominal bloating(30 days (T1 to T2))
- Satisfaction with stool consistency(30 days (T1 to T2))
- Postprandial fullness severity(30 days (T1 to T2))
- Severity of early satiety(30 days (T1 to T2))
- Gastric burning severity(30 days (T1 to T2))
- Improvement in quality of life and mental health(30 days (T1 to T2))
- Improvement in quality of life and mental health(30 days (from T1 to T2))
- Intestinal permeability indicators(30 days (T1 to T2))