ID-JPL934 for Abnormal Bowel Movement
Primary Purpose
Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ID-JPL934
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Seoul National University Bungdang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ID-JPL934
placebo
Arm Description
probiotics 20%, corn starch 80%
corn starch 100%
Outcomes
Primary Outcome Measures
symptom improvement effect
symptom questionnaire survey
Secondary Outcome Measures
VAS score
Visual analogue scale score(10-point scales)
QoL score
Quality of Life score (5-point scales)
Full Information
NCT ID
NCT03395626
First Posted
January 4, 2018
Last Updated
January 29, 2018
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03395626
Brief Title
ID-JPL934 for Abnormal Bowel Movement
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2017 (Actual)
Primary Completion Date
October 2, 2017 (Actual)
Study Completion Date
March 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, double-blind, placebo-controlled, parallel-group
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ID-JPL934
Arm Type
Experimental
Arm Description
probiotics 20%, corn starch 80%
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
corn starch 100%
Intervention Type
Dietary Supplement
Intervention Name(s)
ID-JPL934
Intervention Description
probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
corn starch
Primary Outcome Measure Information:
Title
symptom improvement effect
Description
symptom questionnaire survey
Time Frame
8week
Secondary Outcome Measure Information:
Title
VAS score
Description
Visual analogue scale score(10-point scales)
Time Frame
8week
Title
QoL score
Description
Quality of Life score (5-point scales)
Time Frame
8week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Seoul National University Bungdang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34158518
Citation
Shin CM, Choi YJ, Lee DH, Moon JS, Kim TY, Kim YK, Lee WH, Yoon H, Park YS, Kim N. Validity and safety of ID-JPL934 in lower gastrointestinal symptom improvement. Sci Rep. 2021 Jun 22;11(1):13046. doi: 10.1038/s41598-021-92007-3.
Results Reference
derived
Learn more about this trial
ID-JPL934 for Abnormal Bowel Movement
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