Clinical Trial for the evaluation of the efficacy and safety of Lactobacillus kefirgranum PRCC-1301 purified extracellular vesicle with Irritable Bowel Symptoms
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006139
- Lead Sponsor
- PROSTEMICS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 88
1. Those who agree to participate in this examination and voluntarily signs a written consent form
2. Adult men and women aged 18 or older and 75 or younger
3. Those who have experienced abdominal pain at least once a week for at least three months within six months of visit 1, and falls under at least two of the following three cases:
1) Stomach pain symptoms are related to bowel movement
2) Symptoms occur related to changes in the number of bowel movement
3) Symptoms related to changes in forms of bowel movement
1. Patients with uncontrolled hypertension(based on visit 1, systolic pressure of 180 mm Hg or higher, diastolic pressure of 110 mm Hg or higher, after stabilizing for 10 minutes)
2. Patients with uncontrolled diabetics(based on visit 1, fasting blood sugar 200 mg/dl or higher)
3. Those with history of chronic diseases diagnosed within 6 months of visit 1, such as malignancy, cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment), etc. (but those with history of cerebrovascular and heart disease but who are clinically stable may participate in the test at the discretion of the investigator)
4. Those who have history of abdominal surgery excluding appendectomy and hernia surgery
5. Those who are taking Irritable Bowel Syndrome (IBS) treatment
6. Those diagnosed with inflammatory bowel disease or those with constipation-predominant irritable bowel symptoms
7. Those with lactose intolerance not controlled by food
8. Those who have any warning symptoms or warning signs of suspected organic disease
* Warning symptoms: ? first symptoms occuring after age 50, ? symptoms with weight loss, ? severe diarrhea with hematochezia, ? fever, ? night symptoms, ? dysphagia
* Warning signs: (1) Bloodstain shown in digital rectal exam, ? signs of anemia, ? abdominal mass, ? signs of intestinal obstruction, ? signs of malabsorption, ? signs of thyroid dysfunction
9. Those who have taken medications that affect gastrointestinal exercise(antispasmodics, prokinetics, antidiarrheals, laxatives) and dietary fiber supplements within two weeks of visit 1
10. Those who have consumed probiotic-health functional food within one week of visiting 1, or lactobacillus products such as fermented milk sustainedly(at least four times a week)
11. Those whose Creatinine is more than twice the normal upper limit of the testing institution
12. Those whose AST(GOT) or ALT(GPT) is more than four times the normal upper limit of the test institution
13. Those whose fecal calprotectin is more than four times the normal upper limit of the test institution
14. Those who are pregnant, breastfeeding, or have pregnancy plan during this human application test(women of fertile period can participate only if urine HCG test results are negative)
15. Those who have participated in another interventional clinical trial(including human application test) within three months of the commencement of this human application test, or plans to participate in another interventional clinical trial(including human application test) after the commencement of this human application test
16. Those who are judged inappropriate for this human application test by the investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity improvement rate of irritable bowel symptoms after 8 weeks of intake(fraction reduced by more than 50 points when IRS-SSS total score is applied)
- Secondary Outcome Measures
Name Time Method Severity improvement rate of irritable bowel symptoms after 4 weeks of intake;Individual items of severity improvement rate of irritable bowel symptoms after 4 and 8 weeks of intake;Number and form of bowel movements;Severity of irritable bowel symptoms and availability in the controllment of symptoms ;Overall improvement of irritable bowel symptoms;Quality of life assessment related to irritable bowel syndrome;Evaluation of satisfaction(overall satisfaction with the test and whether if the subjects want to continue in the future);Adverse reaction;Vital signs(blood pressure, pulse);Weight;Clinical laboratory test(Complete blood cell count/Admission Batt/Urinary test)