Validity and Safety of Symptom Improvement of ID-JPL934 for Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain: Randomized, Double-blind, Placebo-controlled, Parallel-group Study
试验速览
- 阶段
- 不适用
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- symptom improvement effect
研究概览
简要总结
Probiotics, which are part of the human body, are microorganisms, which are known to have beneficial effects when consumed in a certain amount, and have the function of controlling intestinal flora and inhibiting inflammation. Recently, probiotics have received much attention in the treatment of hypersensitivity syndrome. The aim of this study was to investigate the effect of probiotic strains, ID-JPL934, in the diagnosis of irritable bowel syndrome.
Overall satisfaction with improvement of bowel habits such as diarrhea and constipation as well as abdominal discomfort and abdominal discomfort in the group receiving ID-JPL934 capsules (test food group or test group) and control group (control food group or control group) (0-10 point visual analogue scale) for each symptom before and after ingestion to evaluate the degree of improvement of the symptoms. The purpose of this study was to investigate the relationship between bacterial composition changes in the stool and the improvement of symptoms in the patients before and after ingestion.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Korean men and women aged over 19 and 80
- •Adults with the following criteria (1) If the symptoms are relieved by bowel movements and changes in the number of bowel movements with less than two stomach complaints or stomach complaints every three months (2), these two forms of bowel movements have started (3)
- •Methodological-fractive women or fertile women who are negative during pregnancy diagnostic tests (urine or seron- hCG). An appropriate method of birth control (e.g., " oral contraceptive " or bi-fertility) during an examination
- •People who have no problems in their nerves and mental systems and who can make their own doctors clear
- •The person who agreed in writing to this test
排除标准
- •Persons with hypersensitivity to probiotics
- •Pregnant or lactating women
- •People who have received other clinical trial drugs within the first 3 months of visit
- •However, in the case of lactic acid bacteria preparation, the test can be taken after a two week absence period.
- •A person who believes that the participant is in a condition or situation in which participation in the clinical trial may be hazardous to the participant,
- •Patients with severe congestive heart failure or severe angina
- •If the patient is diagnosed as having urticaria or immunosuppression
- •Patients who are taking or taking medications (formulants, lactic acid bacteria) that may affect the test food, probiotics, or during the test period. However, if you are taking the drug, you can take the test after two weeks of abstinence.
- •If the systolic blood pressure measured at Visit 1 is greater than 160 mmHg or diastolic blood pressure is greater than 100 mmHg and hypertension is not controlled regardless of whether the medication is administered or not.
- •Patients with uncontrolled endocrine diseases (such as diabetes), metabolic diseases (eg secondary hyperlipidemia) or hypothyroidism (subjects with a history of hypothyroidism) should receive a stable thyroid hormone supplement for at least 4 weeks prior to visit 1 If you are on therapy, you can participate in this test only if the TSH level measured at Visit 2 is within the normal range.)
- •If kidney function is impaired at visit 1 (creatinine> 2.0 mg / dL) or nephrotic syndrome is observed
- •If the cancer has developed within the past 5 years (unless it is determined to be cured)
- •If there is a history of mental instability and drug / alcohol abuse within the past 5 years, or if major psychiatric illnesses are not adequately controlled and stabilized by medication
- •Visits 1 If you have taken mental nerve agents within the previous 3 months
- •If you take a systemic steroid preparation within 1 month before visit 1
- •Patients who underwent abdominal surgery except for appendectomy, hernia surgery, and cesarean section
- •People who are suffering from hypersensitivity syndrome in the ROME Ⅲ standard
- •Any person deemed inappropriate for the judgment of the clinician
研究组 & 干预措施
ID-JPL934
probiotics 20%, corn starch 80%
干预措施: ID-JPL934 (Dietary Supplement)
placebo
corn starch 100%
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
symptom improvement effect
时间窗: 8week
symptom questionnaire survey
次要结局
- VAS score(8week)
- QoL score(8week)