CClinicalTrials.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this record recently (last verified Aug 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

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.

02

Conditions studied

  • Abnormal Bowel Movement Such as Constipation, Diarrhea, Abdominal Pain
03

Who can participate

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

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 birth control (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 hypersensitivity 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 immunosuppression
  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 steroid 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
04

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

05

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

06

Study locations

1 site
  • Seoul National University Bungdang Hospital
    Seongnam-si, Gyeonggi-do 13620, Korea, Republic of
07

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

08

Registry details

Key details

Study ID
NCT03395626
Lead sponsor
Seoul National University Hospital
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 ↗

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