Efficacy Study of a Food Supplement Based on an Extract of Green Tea (Camellia Sinensis (L.) Kuntze - Folium) and a Pool of Probiotics (L. Plantarum, L. Rhamnosus and B. Animalis Subsp. Lactis) for the Management of Gastrointestinal Discomfort and for the Maintenance of the Balance of Intestinal Function in Subjects With Irritable Bowel Syndrome (Irritable Bowel Syndrome - IBS) With Predominance of Constipation (IBS-C): Single-center, Controlled, Randomized, Parallel-arm, Double-blind Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Efficacy of the food supplement in the overall improvement of perceived gastrointestinal symptoms.
研究概览
简要总结
The study will aim to evaluate the effectiveness of the use of a food supplement, based on a green tea extract (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis), in the management of gastrointestinal distress in the general population and in subjects with IBS in the predominant form of IBS-C, with an impact on quality of life.
The primary outcome is the overall improvement of perceived gastrointestinal symptoms in subjects with IBS in the predominant form of IBS-C; than the secondary outcomes are the 1) assessment of the impact of constipation on perceived quality of life in the last 4 weeks, 2) effectiveness in improving stool consistency, 3) effectiveness of the frequency of bowel movements, 4) efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS, 5) effectiveness of the decrease in frequency in the use of salvage treatments 6) efficacy against abdominal pain to be evaluated separately from intestinal discomfort 7) evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin and 8) probiotic colonization rate, improving the quality of life of the subjects affected by IBS-C.
详细描述
The IBS-THE-PROB25 study aims to understand whether a food supplement based on green tea and a mix of probiotics can help people suffering from Irritable Bowel Syndrome with constipation (IBS-C). The main goal is to see if this supplement improves the overall symptoms perceived by people with IBS-C.
Study participants are between 18 and 70 years old and have symptoms of IBS-C for at least 3 months, with constipation problems such as going to the bathroom less than 3 times a week and often having hard stools. There are also criteria why some people will not be able to participate, such as those who have other intestinal diseases or take certain medications.
Participants will be randomly divided into two groups. One group will take the supplement with green tea and probiotics, the other group will take a placebo (an inactive substance that looks the same as the supplements). In particular, the study plans to recruit 64 subjects (32 subjects per group), who will be randomized into the following experimental groups:
GROUP 1 (32 subjects) subjects who will have to take the food supplement, an extract of green tea (Camellia sinensis (L.) Kuntze - folium) and a pool of probiotics (L. plantarum, L. rhamnosus and B. animalis subsp. lactis) GROUP 2 (32 subjects) subjects who will have to take placebo. Each subject of the two experimental groups before, during and after the administration of the dietary supplement or placebo, will undergo the evaluation of the primary and secondary outcomes. Neither participants nor doctors will know who is taking what (double-blind study). Clinicians will collect information about participants symptoms through questionnaires.
Specifically, a questionnaire called IBS-SSS will be used to assess the overall severity of symptoms. Quality of life, stool consistency (using the Bristol Scale), frequency of bowel movements, frequency and intensity of specific symptoms such as bloating and pain, use of "rescue" medications (such as laxatives) and abdominal pain will also be taken into account. A small group of participants will also need to provide stool samples to analyze substances that indicate inflammation and to see if probiotics "colonize" the gut.
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
- Triple (Participant, Care Provider, Investigator)
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
- •aged between 18 and 70 years
- •able to understand and sign informed consent
- •HIV negative test
- •negative pregnancy test
- •With IBS symptoms for at least 3 months (with onset at least 6 months earlier)
- •recurrent abdominal pain at least 1 day a week, associated with two or more of the following criteria: associated with the act of defecation, associated with a change in the frequency of bowel movements, associated with a change in the shape of the stool (Rome IV diagnostic criteria)
- •who have less than three BM/wk and at least one of the following conditions:
- •in more than 25%* of defecatory acts
- •lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements
- •feeling of incomplete evacuation in more than 25% of defecations
- •feeling of anorectal obstruction/blockage in more than 25% of defecations
- •carry out manual manoeuvres to facilitate evacuation in more than 25% of defecations
- •Able to understand and comply with the requirements of the protocol.
排除标准
- •pregnancy
- •lactation
- •HIV positive
- •do not meet inclusion criteria.
结局指标
主要结局
Efficacy of the food supplement in the overall improvement of perceived gastrointestinal symptoms.
时间窗: [Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)]
Validated questionnaire for self-assessment of the severity of global gastrointestinal symptomatology characterizing IBS, IBS Severity Scoring System (IBS-SSS). The questionnaire consists of 5 items referring to: abdominal pain, bowel dysfunction and general well-being. It is commonly used as an outcome measure in clinical efficacy trials, due to its high sensitivity following treatment. The total score obtained allows to determine the severity of global gastrointestinal symptoms, whether IBS-related symptoms are mild, moderate or severe and whether, following treatment, there is an improvement in global symptoms in the treated group compared to the placebo group.
次要结局
- The effectiveness of the decrease in frequency in the use of salvage treatments.([Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)])
- Probiotic colonization rate.([Time frame: baseline (t0), day 56 (t56g), day 84 (t84g)])
- The effectiveness of the frequency of bowel movements.([Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)])
- The efficacy against abdominal pain to be evaluated separately from intestinal discomfort.([Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)])
- Evaluation of the reduction of intestinal inflammatory status through the analysis of fecal inflammatory markers Calprotectin and Zonulin([Time frame: baseline (t0), day 56 (t56g), day 84 (t84g)])
- The effectiveness in improving stool consistency.([Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)])
- The efficacy with respect to the frequency and intensity of the characteristic symptoms of IBS.([Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)])
- Assessment of the impact of constipation on perceived quality of life in the last 4 weeks([Time frame: baseline (t0), day 28 (t28d), day 56 (t56d), day 84 (t84d)])