ClinicalTrials.gg
Status unknownNCT03395626Updated Jan 30, 2018

ID-JPL934 for Abnormal Bowel Movement

An interventional study of ID-JPL934 and Placebo in Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-30.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jul 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Diarrhea with a site in Korea, Republic of — none open to participants now, 1 under way, none of them phase 3. Diarrhea · Korea, Republic of.

Enrollment
4th of 11
112 · median 70
Started
2017
the only one that year
No phase
6 of 11
none open now
Registered
7th of 11
by date
Lead sponsor
4 of 11
Seoul National University Hospital

Among the 11 studies in Diarrhea with a site in Korea, Republic of, this one is the 4th largest by enrollment, is the only one that started in 2017, is one of 6 with no phase, and was the 7th registered.

Diarrhea

877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.

Browse Diarrhea studies →

Open to participants now

None of the 11 studies in Diarrhea with a site in Korea, Republic of is open now. The open studies under Diarrhea, anywhere →

Who these studies take

Of the 45 Diarrhea studies recruiting now, 21 (47%) set no upper age limit and 22 (49%) stop at 75 or younger; 19 take children under 18; 15 take healthy volunteers.

This study: 19 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 11 studies in Diarrhea with a site in Korea, Republic of as a file.
02

Study 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.

03

Conditions studied

  • Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain
04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Korean men and women aged over 19 and 80
  2. 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)
  3. Methodological-fractive women or fertile women who are negative during pregnancy diagnostic tests (urine or seron- hCG). An appropriate method of (e.g., " oral contraceptive " or bi-fertility) during an examination
  4. People who have no problems in their nerves and mental systems and who can make their own doctors clear
  5. The person who agreed in writing to this test

Exclusion criteria

Exclusion Criteria:

  1. Persons with to probiotics
  2. Pregnant or lactating women
  3. 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.
  4. 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,
  5. Patients with severe congestive heart failure or severe angina
  6. If the patient is diagnosed as having urticaria or
  7. 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.
  8. 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.
  9. 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.)
  10. If kidney function is impaired at visit 1 (creatinine> 2.0 mg / dL) or nephrotic syndrome is observed
  11. If the cancer has developed within the past 5 years (unless it is determined to be cured)
  12. 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
  13. Visits 1 If you have taken mental nerve agents within the previous 3 months
  14. If you take a systemic preparation within 1 month before visit 1
  15. Patients who underwent abdominal surgery except for appendectomy, hernia surgery, and cesarean section
  16. People who are suffering from hypersensitivity syndrome in the ROME Ⅲ standard
  17. Any person deemed inappropriate for the judgment of the clinician
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
112 participants (actual)

Study arms

  • Experimental
    ID-JPL934

    probiotics 20%, corn starch 80%

    Dietary Supplement: ID-JPL934

  • Placebo comparator
    placebo

    corn starch 100%

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementID-JPL934

    probiotics

  • Dietary supplementPlacebo

    corn starch

06

What researchers measure

Primary outcomes

  1. symptom improvement effect

    symptom questionnaire survey

    Time frame: 8week

Secondary outcomes

  1. VAS score

    Visual analogue scale score(10-point scales)

    Time frame: 8week

  2. QoL score

    Quality of Life score (5-point scales)

    Time frame: 8week

07

Study locations

1 site
  • Seoul National University Bungdang Hospital
    Seongnam-si, Gyeonggi-do 13620, Korea, Republic of
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2017 to primary completion in Oct 2017, 2 months.

Of 129 non-industry interventional studies with no phase under Diarrhea, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 2 months is below that.

Counting every sponsor, half of 164 studies reached it within 14 months; a quarter within 5 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2018
First posted
Jan 10, 2018
StartActual
Jul 12, 2017
Primary completionActual
Oct 2, 2017
CompletionEst.
Mar 31, 2018
Last update
Jan 30, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03395626
Responsible party
Sponsor
First posted
Jan 10, 2018
Start date
Jul 12, 2017
Primary completion
Oct 2, 2017
Completion
Mar 31, 2018 (estimated)
Last update
Jan 30, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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