Efficacy of a Mix of Specific Enzymes and Peptidases in Reducing Food-Related Abdominal Bloating: A Multicenter, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Change in Post-Prandial Abdominal Bloating Intensity
研究概览
简要总结
This multicenter, randomized, controlled clinical trial aims to evaluate the efficacy and safety of a dietary supplement containing a combination of digestive enzymes (alpha-galactosidase, beta-galactosidase, and prolyl-endopeptidase) in reducing post-prandial abdominal bloating in adults diagnosed with irritable bowel syndrome (IBS).
Participants will be randomly assigned in a 1:1 ratio to receive either the enzyme supplement (Galactol®) in addition to a diet excluding foods high in FODMAPs, or the diet alone. The intervention will be administered for 14 days.
The primary objective is to assess the change in the intensity of post-prandial abdominal bloating measured using a visual analogue scale (VAS). Secondary outcomes include changes in intestinal symptoms, stool consistency, bowel movement frequency, episodes of diarrhea, global gastrointestinal well-being, and treatment tolerability.
The results of this study will provide evidence regarding the potential role of enzyme supplementation in reducing gastrointestinal symptoms associated with food-related fermentation in patients with IBS.
详细描述
Irritable bowel syndrome (IBS) is a common functional gastrointestinal disorder frequently associated with post-prandial abdominal bloating and other intestinal symptoms. Certain dietary components, particularly foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs), can contribute to symptom development through increased intestinal fermentation and gas production.
Dietary strategies such as restriction of high-FODMAP foods are commonly used to manage IBS-related symptoms. However, maintaining strict dietary restrictions can be difficult in routine clinical practice. Enzyme supplementation that facilitates the digestion of specific carbohydrates and gluten-related peptides may represent an alternative or complementary strategy to reduce intestinal fermentation and associated symptoms.
Galactol® is a dietary supplement containing alpha-galactosidase, beta-galactosidase, and a prolyl-endopeptidase derived from Aspergillus niger. These enzymes are intended to promote the digestion of fermentable carbohydrates and gluten-related peptides that may contribute to gastrointestinal discomfort.
This study is designed as a prospective, multicenter, randomized, controlled clinical trial with two parallel groups. Adult participants diagnosed with IBS according to Rome IV criteria and experiencing food-related abdominal bloating will be enrolled.
Participants will be randomly assigned in a 1:1 ratio to receive either Galactol® supplementation in addition to a diet excluding foods high in FODMAPs, or the diet alone. The treatment period will last 14 days.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Diagnosis of irritable bowel syndrome (IBS) according to Rome IV criteria
- •Presence of abdominal discomfort and bloating related to food ingestion
- •Ability and willingness to provide written informed consent
排除标准
- •Age under 18 years
- •Antibiotic therapy within 30 days prior to enrollment
- •Presence of organic gastrointestinal diseases
- •History of digestive system resection
- •Pregnancy or breastfeeding
- •Drug use or alcohol abuse during the study period
- •Inability or refusal to provide written informed consent
研究组 & 干预措施
Galactol® + High-FODMAP Exclusion Diet
Participants receive Galactol® enzyme supplementation in addition to a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs). The supplement is administered as two tablets at lunch and two tablets at dinner daily for 14 days.
干预措施: High-FODMAP Exclusion Diet (Behavioral)
High-FODMAP Exclusion Diet Alone
Participants follow a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs) without receiving the enzyme supplement during the 14-day study period.
干预措施: High-FODMAP Exclusion Diet (Behavioral)
Galactol® + High-FODMAP Exclusion Diet
Participants receive Galactol® enzyme supplementation in addition to a diet excluding foods high in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAPs). The supplement is administered as two tablets at lunch and two tablets at dinner daily for 14 days.
干预措施: Galactol® (Dietary Supplement)
结局指标
主要结局
Change in Post-Prandial Abdominal Bloating Intensity
时间窗: Baseline (Day 0) to Day 14
Change in the intensity of post-prandial abdominal bloating measured using a 0-10 visual analogue scale (VAS), where 0 indicates no symptoms and 10 indicates the worst symptoms.
次要结局
- Change in Intestinal Symptoms(Baseline to Day 14)
- Change in Stool Consistency(Baseline to Day 14)
- Change in Frequency of Bowel Movements(Baseline to Day 14)
- Episodes of Diarrhea(Baseline to Day 14)
- Global Gastrointestinal Well-Being(Day 14)
- Treatment Adherence and Tolerability(Day 14)
研究者
Dr. Amjad Khan
Professor of Clinical Biochemistry and Experimental Medicine
Liaquat University of Medical & Health Sciences