The Efficacy of Lactobacillus plantarum CJLP243 in Patients With Non-constipated Irritable Bowel Syndrome or Functional Diarrhea with High Fecal Calprotectin Levels; A Randomized, Double-blind, Placebo-controlled Trial

Ajou University Hospital0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年12月2日

适应症

试验速览

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•i).Rome III standards are as follows.
•Abdominal discomfort or pain for 3 or more days in the past 3 months and the following 3 symptoms - (1) symptoms relieved after defecation, (2) symptoms started with a change in the frequency of bowel movements, (3) accompanied by a change in stool form with onset of symptoms - when two or more of these occur.
•ii). Rome IV criteria are as follows.
•Symptoms started 6 months ago and within the last 3 months (1) Dissolved stools without abdominal pain or severe bloating (2) Dissolved stools more than 25%
•- Those who are 19 years of age or older
•- Those who have no organic lesions in the colon during colonoscopy within the last 2 years
•iii) Fecal calprotectin levels >11.5 mg/kg

•- Organic bowel disease (Crohn's disease, celiac disease, ulcerative colitis, malignant tumor of the colon)
•- In case of previous bowel surgery except appencdectomy)
•- In case of liver cirrhosis, liver cancer, chronic renal failure, congestive heart failure, hypo/hyperthyroidism, etc.
•- If there are warning symptoms such as rectal bleeding or weight loss of 10% or more within the last 6 months
•- If the subjects have recently traveled to an area with an epidemic parasitic disease
•- Pregnant women, lactating women, etc.
•- Genetic diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption

发起方

Ajou University Hospital