Single Arm Study to Evaluate the Efficacy of Lacticaseibacillus Paracasei Strain Shirota (Formerly Lactobacillus Casei Strain Shirota) Fermented Milk (Yakult®) on the Maintenance of Clinical Manifestations of Functional Constipation in Mexican Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Clinical manifestation of functional constipation
研究概览
简要总结
Chronic functional constipation is a gastrointestinal disorder with an approximate prevalence of 14% of the Mexican population, which is characterized by difficult or incomplete defecation and/or infrequent bowel movements, with the absence of symptoms such as abdominal pain or inflammation, and in If they occur, they should not be the predominant symptoms. Its origin is multifactorial and includes variables such as diet, water consumption, alteration in motility, and intestinal microbiota, the latter as a source of different secondary metabolites such as short-chain fatty acids (SCFAs).
Lower SCFA values in constipation would alter the relationship between them, increasing the risk of clinical manifestations of functional chronic constipation. In addition to physical discomfort, subjects with this disease manifest alterations in their quality of life.
Recent studies have suggested using probiotic microorganisms to treat this functional disorder due to their beneficial effects on evacuation frequency, SCFAs, and quality of life. However, in Mexico, knowledge of the above is limited. Therefore, this research aims to determine the effect of consuming a product based on fermented milk with the probiotic Lacticaseibacillus paracasei strain Shirota on the clinical manifestations of functional constipation in Mexican adults and its relationship with SCFAs.
详细描述
- Background
Constipation is an intestinal disorder characterized by difficulty defecating, infrequent bowel movements, hard or lumpy stools, excessive straining, a feeling of incomplete evacuation, and, in some cases, the use of manual techniques to facilitate evacuation.
Due to its presentation time, constipation is classified as acute or chronic. The acute one lasts less than a week and is commonly determined by a change in diet and/or lifestyle (low fiber intake, decreased physical activity, stress, going to the bathroom in an unknown place, etc.). For its part, the symptoms of chronic illness have occurred over three to six months. Chronic constipation is among the most common gastrointestinal conditions, usually primary or secondary. The first is a consequence of multiple pathophysiological alterations, such as alteration of colonic regulation, lack of coordination of the neuromuscular apparatus, and dysfunction of the brain-gut axis. In turn, secondary chronic constipation can be caused by drugs, neurological disorders, anatomical processes, or metabolic diseases.
Chronic constipation is defined "from a clinical point of view, chronic constipation is considered secondary when it is a consequence of metabolic, neurological alterations, structural lesions or medications. When other causes have been excluded, it is considered primary, idiopathic, or functional constipation" (FD).
1.1. Clinical manifestations
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 20 and 60 years old, diagnosed with functional chronic constipation (according to the Rome IV criteria).
- •Men and women who have given informed consent.
排除标准
- •Constipation due to neurological, pharmacological or organic causes.
- •Pregnancy or pregnancy expected within the next month.
- •Breastfeeding women.
- •Diagnosed pathologies such as: diabetes mellitus, kidney or liver failure, infectious disease, inflammatory disease or any neoplastic disease.
- •Use of laxatives within 14 days prior to the start of the intervention.
- •Use of antibiotics within 14 days prior to the start of the intervention.
- •Diagnosis of cancer in the last three years.
- •History of drug and medication abuse.
- •Active alcoholism with a daily intake greater than 50 g/day.
- •Lactose intolerance.
- •Known allergies to any substance in the study product (e.g., cow's milk proteins).
- •Any subject who needs manual maneuvers to evacuate feces.
- •Anticipated major changes in diet or exercise during the study period.
- •Eating disorders.
- •Participation in another study with any investigational product within 3 months prior to enrollment.
- •Regular Yakult consumers
- •Subject who does not have the capacity to consent.
结局指标
主要结局
Clinical manifestation of functional constipation
时间窗: 2 months
Clinical manifestation will be measure by Bristol scale (1-2 hard stools; 3-4 normal; 4-5 soft stools), Frequency of bowel movements will be obtained by the question of how many times per week have defecated, meanwhile severity of symptoms related to constipation will include indicators of difficulty passing stool, pain, and feeling of incomplete evacuation on a 4-point scale (1, none; 2, a little; 3, some; and 4, a lot)
次要结局
- Body Mass Index (BMI)(2 months)
- Analysis of short-chain fatty acids(2 months)
- Height(2 months)
- Body weight(2 months)