Status:
UNKNOWN
ID-JPL934 for Abnormal Bowel Movement
Lead Sponsor:
Seoul National University Hospital
Conditions:
Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain
Eligibility:
All Genders
19-80 years
Phase:
NA
Brief Summary
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 an...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Persons with hypersensitivity to probiotics
- Pregnant or lactating women
- People who have received other clinical trial drugs within the first 3 months of visit 1. 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
Key Trial Info
Start Date :
July 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2018
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03395626
Start Date
July 12 2017
End Date
March 31 2018
Last Update
January 30 2018
Active Locations (1)
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1
Seoul National University Bungdang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620