Effects of Synbiotics on Functional Constipation and Other Contributing Factors Among Constipated Individuals in Serdang, Selangor, Malaysia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 主要终点
- Stool types - Bristol Stool Form (BSF) Scale
研究概览
简要总结
Prevalence of functional constipation (FC) was first determined with 15.2% reported. Next, a 16-week randomised, double-blind, placebo-controlled study conducted to assess the improvement in functional constipation among the respective individuals by using synbiotic supplement. Throughout the intervention, it was reported that significant improvements for defecation frequency, Bristol Stool Form (BSF) scale, and Patients Assessment of Constipation Symptoms (PAC-SYM) scores were reported within synbiotic group (p < 0.001). However, no significant different was reported when compared both groups as placebo group was found to have significant within-group difference too. Placebo effect was suspected in this study.
详细描述
Digestive system disease is the top ten principal causes of morbidity and mortality among Malaysians whereby functional constipation (FC) is the commonest functional gastrointestinal disorders (FGIDs) reported. Although numerous treatments are available, but over-the-counter drugs which have low product safety and possible toxicity were always given as the treatment option. Synbiotic have been well-studied to improve digestive health includes constipation. Thus, the objectives of this study were to determine the prevalence of FC and to evaluate the effects of synbiotic supplement on improving FC symptoms and contributing factors among constipated individuals in Serdang, Selangor. This study comprised of two parts which were screening and intervention part. The prevalence of functional constipation was relatively high in the study community. Synbiotic supplement was effective in the improvement of functional constipation symptoms, quality of life, and psychological factors. However, the positive improvement in placebo group indicated the existence of placebo effects which led to the improvement in quality of life and changes in psychological factors. Therefore, the current findings are useful information for future intervention in improving functional constipation symptoms.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Malaysian of either gender;
- •18 to 65 years old;
- •Body mass index (BMI) 16.0 to 29.9 kg/m2;
- •Positively diagnosed with functional constipation with Rome III-defined constipation module by the gastroenterologist
排除标准
- •Vulnerable groups of pregnant and breastfeeding women;
- •Physically or mentally handicapped individuals;
- •Diagnosed with organic constipation (constipation associated with any neoplastic diseases, neuropathy or mechanical obstruction);
- •Diagnosed with cardiovascular diseases, diabetes mellitus, cancer, neurological disease or other serious illnesses or severe medical complications;
- •Faced alarm features indicative of colorectal cancer, metabolic disease and a history of gastrointestinal surgery.
- •To avoid the likelihood of co-intervention bias, the following respondents were excluded:
- •On gastrointestinal medications;
- •Consumed probiotics or synbiotic products more than once a week in two weeks preceding screening or during intervention period;
- •Regularly used laxatives (more than once per week), used anticholinergics, anti-diarrheals, antibiotics or laxative in two weeks preceding screening or at any point during intervention.
研究组 & 干预措施
Placebo
Placebo contains only maltodextrin without any active ingredients, equally same in physical form, freeze-dried white powder with characteristic odor and water soluble as the synbiotic supplement.
干预措施: Placebo (Dietary Supplement)
Synbiotic
The product contained three clinically studied active ingredients namely inulin-oligofructose (prebiotic; derived from chicory root), at least 6 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01 (probiotic) and 4 B CFU of Bifidobacterium lactis BB12 (probiotic) per sachet.
干预措施: Synbiotic (Dietary Supplement)
结局指标
主要结局
Stool types - Bristol Stool Form (BSF) Scale
时间窗: 16 weeks
BSF scale was used to characterise human stools to seven classifications using seven pictorial presentation of stool types.Type 1 stool shows the very slow transit time with longest time spent in the colon whereas Type 7 indicates the least time spent in the colon and has fast bowel transit time. Meanwhile, Type 4 is the most ideal stool type optimal colonic transit time.
Constipation symptoms - Patients Assessment of Constipation Symptoms (PAC-SYM)
时间窗: 16 weeks
PAC-SYM consists of a total of 12 questions includes abdominal symptoms, rectal symptoms, and stool symptoms. It comprised with a 5-point Likert scale ranging from 0 (Absent) to 4 (Very severe). The values of subscales and total scores for PAC-SYM were then computed as average item response within the scales and for the global score. Lower score obtained indicates less symptom severity.
Defecation frequency
时间窗: 16 weeks
Defecation frequency was measured through participants' self reported defecation frequency in a week.
次要结局
- Quality of life - Patients Assessment of Constipation Quality of Life (PAC-QOL)(16 weeks)
- Psychological factor - Depression, Anxiety, and Stress scale (DASS)(16 weeks)
研究者
Assoc. Prof. Dr. Rosita Jamaluddin
Assoc. Prof. Dr.
Universiti Putra Malaysia