A randomized, double-blind, controlled trial of a novel pre-probiotic formulation; assessing changes in GUT health in adults with GUT issues (Indigestion, Acidity, Bloating and Gas formation).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in the GUT issues (Indigestion, Acidity, Bloating and Gas formation), assessed through structured interviews at baseline & day 30, Assessed using 15 point gastrointestinal symptom rating scale (GSRS) scale.
研究概览
简要总结
Probiotics, as defined by the World Health Organization, are live microorganisms that, when administered in adequate amounts, provide a health benefit. They are believed to compete metabolically with pathogens, thereby strengthening the intestinal mucosal barrier and modulating the intestinal inflammatory environment. While probiotics can help restore intestinal microbial balance and gut homeostasis, definitive evidence supporting their efficacy in improving functional gastrointestinal disorders (FGIDs) remains limited.
A novel pre-probiotic blend has been developed for symptom management in FGIDs. Clinical trials have shown that administration of these bacteria, whether individually, in multi-strain blends, or combined with other probiotics and/or prebiotics, improves diarrhea, abdominal pain, bloating, and constipation in FGIDs. This particular combination of strains, administered together, is unique and has not been previously studied. The primary goal of this randomized, placebo-controlled clinical trial was to assess the safety and efficacy of this novel pre-probiotic blend in patients experiencing FGIDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 25.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and females aged 25 to 65 years.
- •Self-reported history of GUT issues like Indigestion, Acidity, Bloating and Gas formation.
- •Participants who can provide informed consent.
排除标准
- •History of hypersensitivity to any of the investigational product, excipients, or Any known food allergies.
- •Small Intestinal Bacterial Overgrowth or carbohydrate intolerances.
- •Pre-existing medical condition or taking medication known to influence digestion and absorption of nutrients.
- •Any clinically relevant abnormal findings which, in the opinion of the investigators, may put participant at risk of adverse events including: Physical examination; Clinical chemistry; Haematology; Vital signs History of diagnosis of gastrointestinal disease, inflammatory bowel disease, or functional gastrointestinal disorders, previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery) or experiencing dysphagia Systemic lupus erythematosus, cancer, thyroid disease, renal disease, hepatic disease, or uncontrolled metabolic disease Individuals taking probiotics, antibiotics, fibre supplements, antacids, proton pump inhibitors, stool softeners or laxatives at time of recruitment or within the previous four weeks Has any allergies or past reactions to ingredients in treatment and placebo Pregnancy or nursing of an infant.
结局指标
主要结局
Improvement in the GUT issues (Indigestion, Acidity, Bloating and Gas formation), assessed through structured interviews at baseline & day 30, Assessed using 15 point gastrointestinal symptom rating scale (GSRS) scale.
时间窗: Day 0, Day 15 and Day 30
次要结局
- Improvement in Digestion-associated Quality of Life Questionnaire (DQLQ).((Day 0 Vs Day 15 Vs Day 30))
研究者
Dr Y Rami Reddy
Star Hospitals