Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal PainNCT03395626
ID-JPL934 for Abnormal Bowel Movement
A study testing ID-JPL934 in people with Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain
- What is being tested?
- ID-JPL934
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jul 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bungdang Hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
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
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.
- Being tested
- ID-JPL934, Placebo
- Medical subject headings
- Diarrhea, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ID-JPL934Dietary supplement
probiotics
PlaceboDietary supplement
corn starch
| Study group | Role | What they receive |
|---|---|---|
| ID-JPL934 | Experimental | probiotics 20%, corn starch 80% Receives: Dietary Supplement: ID-JPL934 |
| placebo | Placebo comparator | corn starch 100% Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom improvement effect
symptom questionnaire survey
Measured: 8week
Secondary outcomes (2)
VAS score
Visual analogue scale score(10-point scales)
Measured: 8week
QoL score
Quality of Life score (5-point scales)
Measured: 8week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start12 Jul 2017
- Primary completion2 Oct 2017
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, placebo-controlled, parallel-group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395626
- Sponsor's protocol ID
- ID-JPL934
- Status last verified
- Aug 2017
- First submitted
- 4 Jan 2018
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34158518
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03395626
- Acronym / sponsor ID
- ID-JPL934
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- randomized, double-blind, placebo-controlled, parallel-group
| Arm | Type | Receives |
|---|---|---|
| ID-JPL934 | Experimental | Dietary Supplement: ID-JPL934probiotics 20%, corn starch 80% |
| placebo | Placebo comparator | Dietary Supplement: Placebocorn starch 100% |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ID-JPL934probiotics | Dietary supplement | ID-JPL934 |
| Placebocorn starch | Dietary supplement | placebo |
Primary outcome
symptom improvement effect
Time frame: 8week
symptom questionnaire survey
2 secondary outcomes
VAS score
Time frame: 8week
QoL score
Time frame: 8week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Derived from this study: PubMed 34158518Shin 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ID-JPL934 in people with Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom improvement effect (time frame: 8week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03395626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.