A Randomized Double-blind, Crossover Clinical Trial to Assess the Efficacy of Lactobacillus Paracasei Enriched Artichokes in the Treatment of Functional Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Treatment preference
研究概览
简要总结
The aim of the present randomized double-blind controlled crossover study is to compare the effects of the 15-day consumption of artichokes enriched with the probiotic Lactobacillus paracasei LMGP22043 with those of ordinary artichokes on treatment preference, satisfactory relief of symptoms, bowel habit and the modulation of SCFA production in a group of patients suffering from functional constipation.
详细描述
Functional constipation is a common problem in westernized societies and is characterized by different gastrointestinal symptoms.Different therapeutic strategies have been proposed, but a new therapeutic approach for constipation could be based on the modulation of intestinal microflora by administering prebiotics and/or probiotics. Currently, probiotic products are mainly incorporated in fermented milk-based products or concentrated probiotic preparations. To enlarge the range of choice and to exploit the nutritional qualities of plant matrices, an innovative line of probiotic vegetable products such as artichokes has been developed. The use of these vegetables containing live probiotic strains can take advantage of some their peculiar features for growth and improved bacterial survival. Artichokes can, therefore, work as valid "active" vehicles for the transport and release of adequate amounts of bacterial populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfilment of the Rome Criteria III for constipation
- •availability of at least one GI imaging study during the last five years(colonoscopy, sigmoidoscopy, abdominal ultrasound, barium enema)
- •commitment to availability for the whole study period
排除标准
- •major abdominal surgery
- •the presence of any concomitant diseases such as organic GI diseases including lactose and gluten intolerance; medical or psychiatric illness
- •alarming symptoms (rectal bleeding, weight loss, etc)
- •family history of peptic ulcer, colorectal cancer, or IBD;
- •abnormal laboratory data or thyroid function.
研究组 & 干预措施
Probiotic-enriched Artichokes
Artichokes containing approximately 1.20 x 10^8 CFU of live probiotic cells of Lactobacillus paracasei IMPC 2.1 LMGP22043 per gramme
干预措施: Lactobacillus paracasei IMPC 2.1 LMGP22043 (Dietary Supplement)
Ordinary artichokes
Ordinary artichokes (probiotic free) of identical shape, texture, and appearance of probiotic-enriched artichokes
干预措施: Ordinary artichokes (Dietary Supplement)
结局指标
主要结局
Treatment preference
时间窗: After treatment with artichokes enriched with probiotics (period 1: 15 days) and at the end of treatment with ordinary artichokes (period 2: 15 days)
The participants will be asked about treatment preference (the period with least symptoms) at the last visit.
次要结局
- Visual analogue score (VAS) of satisfactory relief of symptoms(At the end of the run-in period (7 days), after treatment with artichokes enriched with probiotics (period 1: 15 days) and at the end of treatment with ordinary artichokes (period 2: 15 days))
- GSRS sum score(At the end of the run-in period (7 days), after treatment with artichokes enriched with probiotics (period 1: 15 days) and at the end of treatment with ordinary artichokes (period 2: 15 days))
研究者
Francesco Russo
MD
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis