Probiotics-prebiotic Fiber Therapy Improved Bowel Opening Frequency and Whole Gut Transit Time in Parkinson's Disease Patients With Constipation: A Randomised Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- constipation symptoms
研究概览
简要总结
A double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics on constipation symptoms and whole gut transit time in patients with Parkinson's disease.PD patients with constipation were randomized to receive a multi-strain probiotic (Lactobacillus spp and Bifidobacterium spp at 30 X 109 CFU) with fructo-oligosaccaride (FOS) or placebo (fermented milk) twice daily for 8 weeks. Primary outcomes include changes in the presence of constipation symptoms using 9 items of Garrigues Questionnaire (GQ), which included an item on bowel opening frequency. Secondary and exploratory outcomes include whole gut transit time (WGTT), quality of life (PDQ39-SI), motor (MDS-UPDRS) and non-motor symptoms (NMSS).
详细描述
This was an eight-week double-blind, randomized placebo-controlled intervention study involving 55 idiopathic PD patients attending tertiary hospital. This study was conducted in accordance with good clinical practice as per Declaration of Helsinki and was approved by the institution's Research and Ethics Committee (FF-2018-387). Written informed consent was obtained from all particpants prior to enrollment.
Participants were included if they were aged 18 or older; were diagnosed with idiopathic PD in Hoehn and Yahr stages 1-4, and fulfilled the Rome III criteria for functional constipation which requires the presence of recurrent abdominal pain 3 days per month in the last 3 months, and symptom onset 6 months prior to diagnosis, with additional criteria below to be fulfilled, as adapted from Longstreth, et al12.
-
Must include two or more of the following:
-
Straining during at least 25% of defecations
-
Lumpy or hard stools in at least 25% of defecations
-
Sensation of incomplete evacuation for at least 25% of defecations d. Sensation of anorectal obstruction/blockage for at least 25% of defecations
e. Manual maneuvers to facilitate at least 25% of defecations (e.g, digital evacuation, support of the pelvic floor) f. Fewer than 3 defecations per week 2. Loose stools are rarely present without the use of laxatives 3. There are insufficient criteria for IBS
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)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older; were diagnosed with idiopathic PD
- •PD with Hoehn and Yahr stages 1-4,
- •Fulfilled the Rome III criteria for functional constipation
排除标准
- •MMSE score of ≤ 21/30
- •Positive stool occult blood screening
- •Diagnosis of secondary parkinsonism
- •Previous history of small and large bowel disease
- •History of gastrointestinal tract surgery
- •Use of probiotics or antibiotics two weeks prior to baseline visit
- •Been on medications such as antidepressants or anticholinergics
- •History of lactose intolerance
- •Concomitant diagnosis of hypothyroidism and diabetes mellitus.
结局指标
主要结局
constipation symptoms
时间窗: 8 weeks
The presence of constipation symptoms at baseline and at 8 weeks evaluated by Garrigues Questionnaire (GQ).GQ is a 21-item self-reported screening questionnaire to detect the presence of constipation symptoms, using two different sets of four-point Likert scale responses.Although 12 items assess bowel habits, 9 items specifically assess constipation symptoms and were used in our evaluation: (i)Feeling of blockage in the anus;(ii) Need to press around anus/vagina to complete bowel movement; (iii) Spend \>10 minutes to pass stool;(iv) Straining during bowel movement;(v) Feeling of hard stool;(vi) Feeling of incomplete emptying sensation; (vii)Bowel opening frequency;(viii) Frequency of oral laxative use;(ix) Frequency of enema use
次要结局
- Whole Gut Transit Time (WGTT) in hours(8 weeks)
- Frequency of patients with constipation (Bowel motion < 3 per week) in percentage(8 weeks)
- Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part 11(8 weeks)
- Movement Disorders Society- Unified Parkinson's Disease Rating Scale Part 111(8 weeks)
- Non motor symptom score(8 weeks)
- Parkinsons Disease Quality of Life -39 Summary Index (PDQ39SI)(8 weeks)
- Weight in kilogram(8 weeks)
- Height in metres(Baseline)
- Body Mass Index (kg/m2)(8 weeks)
研究者
Dr Norlinah Mohamed Ibrahim
Professor
National University of Malaysia