A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Efficacy and Safety of Enzymax DuoBiotics in Adults With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Change from baseline in Gastrointestinal Symptom Rating Scale score
研究概览
简要总结
Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder characterized by recurrent abdominal pain associated with altered bowel habits in the absence of detectable structural abnormalities. Its pathophysiology is multifactorial and may involve alterations in the intestinal microbiota, impaired epithelial barrier function, low-grade immune activation, and disturbances in the digestion and fermentation of dietary nutrients.
Enzymax DuoBiotics combines digestive enzymes with a synbiotic formulation in a capsule-in-capsule delivery system. The outer capsule contains digestive enzymes intended for release in the stomach, whereas the inner capsule contains Lactobacillus plantarum and fructooligosaccharides intended for release in the intestine. This formulation is designed to separate the enzymatic and synbiotic components and support their delivery to the intended gastrointestinal sites. The combined approach is intended to support macronutrient digestion while modulating the intestinal microbial environment.
This randomized, double-blind, placebo-controlled, parallel-group study will compare once-daily Enzymax DuoBiotics with placebo over a 12-week treatment period in adults with IBS. Participants will be allocated in a 1:1 ratio, and treatment effects over time will be evaluated using assessments performed during the treatment period. The primary statistical analysis will use linear mixed-effects models including treatment group, time, and the treatment group-by-time interaction. The primary analysis will follow the intention-to-treat principle and may be supplemented by a per-protocol analysis.
详细描述
This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of Enzymax DuoBiotics in adults with irritable bowel syndrome (IBS) diagnosed according to the Rome IV criteria. A total of 120 participants aged 18 to 70 years will be randomized in a 1:1 ratio to receive either Enzymax DuoBiotics or placebo once daily for 12 weeks.
Enzymax DuoBiotics is a dietary supplement formulated using a capsule-in-capsule delivery system. The outer capsule contains the digestive enzymes lipase, protease 4.5, protease 3.0, amylase, and glucoamylase and is intended to be released in the stomach. The inner capsule contains the synbiotic combination of Lactobacillus plantarum and fructooligosaccharides and is intended to be released in the intestine. This formulation is designed to separate the digestive enzymes from the synbiotic components and to support their release at the intended gastrointestinal site.
The primary objective is to evaluate the efficacy of Enzymax DuoBiotics in reducing gastrointestinal symptoms associated with IBS. The primary outcomes will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS) and the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS).
Secondary outcomes will include changes in inflammatory biomarkers, including interleukin-6, interleukin-8, tumor necrosis factor alpha, and C-reactive protein; IBS-related quality of life assessed using the Irritable Bowel Syndrome Quality of Life questionnaire; stool consistency assessed using the Bristol Stool Form Scale; treatment satisfaction; treatment adherence based on capsule count; and safety and tolerability based on the recording of adverse events and assessment of their relationship to the study product.
Assessments will be performed at baseline, Week 6, and Week 12. The Week 6 assessment will be conducted by telephone and will include adherence monitoring and completion of electronic questionnaires. The final assessment at Week 12 will include collection of clinical data and questionnaires, evaluation of treatment adherence, and recording of adverse events. The primary analysis will be conducted according to the intention-to-treat principle and may be complemented by a per-protocol analysis.
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
- Double (Participant, Investigator)
盲法说明
Participants and investigators will remain unaware of treatment allocation throughout the 12-week study period. The active dietary supplement and placebo will be provided in matching coded packaging to maintain blinding.
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
- •Adults aged 18 to 70 years
- •Diagnosis of irritable bowel syndrome according to the Rome IV criteria.
- •Presence of active irritable bowel syndrome symptoms at the time of enrollment.
- •Ability and willingness to provide written informed consent.
- •Ability and willingness to comply with the study procedures and the 12-week treatment period.
排除标准
- •Presence of an organic gastrointestinal disease.
- •Use of antibiotics or probiotics within 1 month before enrollment.
- •Recent clinically relevant changes in diet.
- •Severe comorbid medical conditions.
- •Inability or unwillingness to comply with the study protocol.
- •Known hypersensitivity to any component of Enzymax DuoBiotics or to dietary supplements of similar composition.
- •Any other condition that, in the investigator's judgment, may interfere with participation, study treatment, or interpretation of the results.
研究组 & 干预措施
Placebo
Participants assigned to this arm will receive one placebo capsule orally once daily for 12 weeks. The placebo will be administered according to the same dosing schedule as Enzymax DuoBiotics.
干预措施: Placebo (Dietary Supplement)
Enzymax DuoBiotics
Participants assigned to this arm will receive one capsule of Enzymax DuoBiotics orally once daily for 12 weeks. Enzymax DuoBiotics contains digestive enzymes, Lactobacillus plantarum, and fructooligosaccharides in a capsule-in-capsule delivery system.
干预措施: Enzymax DuoBiotics (Dietary Supplement)
结局指标
主要结局
Change from baseline in Gastrointestinal Symptom Rating Scale score
时间窗: Baseline, Week 6, and Week 12
Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS). The change in the overall GSRS score from baseline to Week 12 will be compared between the Enzymax DuoBiotics and placebo groups. Higher scores indicate greater gastrointestinal symptom severity; therefore, a reduction in score indicates improvement. An intermediate assessment will also be performed at Week 6. The GSRS is a validated instrument for evaluating gastrointestinal symptoms in clinical studies.
Change from baseline in Irritable Bowel Syndrome Severity Scoring System score
时间窗: Baseline, Week 6, and Week 12
Irritable bowel syndrome symptom severity will be assessed using the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS). The change in total IBS-SSS score from baseline to Week 12 will be compared between the Enzymax DuoBiotics and placebo groups. The total score ranges from 0 to 500, with higher scores indicating greater IBS severity; therefore, a reduction in score indicates improvement. An intermediate assessment will also be performed at Week 6.
Change from baseline in Gastrointestinal Symptom Rating Scale overall score
时间窗: Baseline, Week 6, and Week 12
The Gastrointestinal Symptom Rating Scale is a 15-item questionnaire used to assess the severity of gastrointestinal symptoms across five symptom domains: abdominal pain, reflux, indigestion, diarrhea, and constipation. Each item is rated on a 7-point scale ranging from 1, indicating no troublesome symptoms, to 7, indicating very troublesome symptoms. The overall score is calculated as the mean of the item scores and ranges from 1 to 7. Higher scores indicate greater gastrointestinal symptom severity and therefore a worse outcome. Change from baseline will be assessed at Weeks 6 and 12, with the primary comparison performed at Week 12.
Change from baseline in Irritable Bowel Syndrome Severity Scoring System total score
时间窗: Baseline, Week 6, and Week 12
The Irritable Bowel Syndrome Severity Scoring System assesses the severity of irritable bowel syndrome symptoms, including abdominal pain, abdominal distension, satisfaction with bowel habits, and the impact of symptoms on daily life. The total score ranges from 0 to 500. Higher scores indicate greater symptom severity and therefore a worse outcome. Change from baseline will be assessed at Weeks 6 and 12, with the primary comparison performed at Week 12.
次要结局
未报告次要终点