Effectiveness of Partially Hydrolyzed Guar Gum in Improving Fecal Characteristics in Long Term Care Facility Residents
试验速览
- 阶段
- 不适用
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in Fecal characteristics (assessed by Bristol Stool Scale) from baseline at 4 weeks
研究概览
简要总结
Partially hydrolyzed guar gum (PHGG) is a vegetal, water soluble, non-viscous, non-gelling dietary fiber that is derived from guar gum, a water-soluble, viscous, gelling polysaccharide found in the seeds of Cyamopsis tetragonolobus. PHGG is food for special medical purpose and available over-the-counter. It is as effective as lactulose treatment in relieving constipation associated abdominal pain in children. Up-to-date, there is no randomized study regarding the effectiveness of PHGG in reducing constipation in long term care facility residents, the investigator therefore would like to perform a prospective, randomized study to assess its effectiveness in long term care facility residents to improve fecal characteristics and its effect on use of laxative agents.
详细描述
This is a prospective, randomized, single blinded, parallel-group trial for the residents in long term care facilities covered by Community Geriatric Assessment Team of Queen Mary Hospital and Fung Yiu King Hospital. The investigator aim to recruit 52 subjects from those long term care facilities.
Subject fulfilling the inclusion criteria will be screened from the Community Geriatric Assessment Team (CGAT) of Fung Yiu King Hospital by the investigators. Study information will be explained to subject in detail and consent form (in Chinese) will be given to subject. Before commencing, subjects will be allowed to have one week to consider joining the study.
After informed consent, subjects will be randomly assigned into 2 groups. One group receive PHGG following study protocol (treatment group). Another group will be control group, no PHGG will be given. For treatment group, subjects will take 5g PHGG per day (which equals 4.2g dietary fiber) through mixing with 20ml water during treatment period. Since after mixing with PHGG, the water remains colorless and odorless, control group will also be given 20ml water by long term care facility staff as a blinding process to participant.
The study consist of two periods: a 2-week run-in period and a 4-week treatment period. During run-in period, patient's demographic characteristics will be recorded. Eligibility of patients to proceed to the treatment period will be determined, according to their baseline symptoms stool log. Stool frequency, stool characteristics (according to Bristol stool scale ranging from 1: hard stool to 7: liquid stool) and use of laxative medication will be recorded through a record diary given to subjects. During treatment period, both group of subjects need to record stool frequency, stool characteristics and use of laxative medication. Any adverse reaction will be recorded. Satisfaction of subjects towards PHGG will be assessed by questionnaire with quantification through Likert scale. Subjects will be instructed to maintain their usual daily activities including exercise, food habits, and medication consumption.
Outcome measures:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Long term care facility residents at the age of 65 or above.
- •All participants give written informed consent.
- •Participants must be available to complete the study and comply with study procedures
排除标准
- •Previous major surgery of the abdomen
- •Use of PHGG in the 4 months prior to the study initiation
- •Chronic constipation due to primary organic disorder of the large bowel e.g. neoplasia, post-radiation or inflammatory strictures
- •On regular laxative treatment
- •Patient with severe hypothyroidism
- •Patients suffering from disease of the spine cord
- •Subject receiving antibiotics within 3 month
结局指标
主要结局
Change in Fecal characteristics (assessed by Bristol Stool Scale) from baseline at 4 weeks
时间窗: Change from baseline stool characteristics at 4 weeks
Fecal characteristics will be assessed at baseline and at 4 weeks after intervention by Bristol Stool scale. The change of stool characteristics from baseline at 4 weeks will be measured. Bristol stool scale range from 1 (hard stool) to 7 (liquid stool).
次要结局
- Change in frequency of laxative use by participants per week(Change in frequency of laxative use by participant per week from baseline at 4 weeks)
研究者
Dr. Chan Tuen Ching
Honorary Associate Professor
The University of Hong Kong