A Single Arm Trial to Evaluate the Effect of PhytoMulti® Multivitamin and UltraFlora® Balance Probiotic on Bowel Symptoms in Individuals Using GLP-1 Receptor Agonists, Assessed by the IBS Symptom Severity Score (IBS-SSS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- IBS- SSS
研究概览
简要总结
This is a single-arm, open-label clinical trial involving 100 participants who will undergo a total participation period of 12 weeks.
详细描述
The trial begins with a screening to assess eligibility, followed by a 12-week treatment phase during which participants will receive a fixed-dose oral supplementation regimen. During this treatment period, participants will take PhytoMulti® Multivitamin at a fixed dose of 2 tablets per day and UltraFlora® Balance Probiotic at a fixed dose of 1 capsule per day, both administered orally once daily with food. During the 12-week treatment period, participants will be asked to complete questions at fixed timepoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Providing written informed consent
- •Males and females of at least 18 years old
- •Minimum 4 weeks on GLP-1 (f.e Ozempic®, Wegovy®, Mounjaro®, etc.) and maximum 1 year on GLP-1
- •Body Mass Index (BMI) ≥ 25 AND ≤ 30
- •Being willing to maintain stable dietary habits and physical activity levels throughout the trial period
- •Being willing not to introduce any other food supplements during the trial period (supplements used in the two weeks prior to enrolling in the trial and used consistently throughout are acceptable, except for probiotics).
排除标准
- •Having had any type of bariatric surgery, or planned bariatric surgery during the period of trial participation.
- •Suffering from a severe chronic disease (e.g., cancer, HIV, hepatic or renal impairment, diabetes type I), inflammatory bowel disease (IBD), Coeliac Disease, and/or being immunocompromised.
- •Suffering from any uncontrolled endocrine disorder
- •Having used any antibiotic treatment in the 2 months prior to enrollment.
- •Having a known allergy to the ingredients in the study product.
- •Being pregnant or lactating (breastfeeding) or trying to become pregnant.
- •Participating in another clinical trial.
- •Suffering from dementia or inability to take the trial treatment in an appropriate way.
- •Taking PhytoMulti® Multivitamin and/or UltraFlora® Probiotic or any similar product from competitors prior to trial participation
结局指标
主要结局
IBS- SSS
时间窗: From enrollment to the end of treatment at 12 weeks (90 days)
To assess impact of PhytoMulti® multivitamin and UltraFlora® Balance Probiotic on abdominal symptoms using the IBS severity scoring system (IBS-SSS)
次要结局
未报告次要终点