Efficacy of heat-killed Lactiplantibacillus plantarum V10 lysate in patients with irritable bowel syndrome (diarrheal type): a randomized, double-blind, placebo-controlled trial.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011588

Enrollment

Registered

2026-02-09

Start date

2025-09-12

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Take 3 capsules of treated group(Lactobacillus plantarum V10 lysate) or control group(placebo) once a day for 8 weeks. The Lactobacillus plantarum V10 lysate is a health functio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Adults aged 19 to 75 years (2) Those with symptoms of irritable bowel syndrome for more than six months (3) IBS-D according to the Rome IV criteria (4) Those with an IBS-ISS score of 150 or higher (5)Those with a history of colonoscopy within the two years prior to this human clinical trial or those with a pre-clinical colonoscopy that confirmed no abnormalities (7) Those who voluntarily decided to participate and provided written consent (8) Those who can understand and follow instructions and participate for the entire duration of the clinical trial

Exclusion criteria

Exclusion criteria: (1) Previous abdominal surgery (excluding appendectomy and cesarean section) (2) Patients with inflammatory bowel disease (3) Patients with a history or current history of colon cancer (4) Patients with diabetes (5) Subjects with severe cardiopulmonary disease or malignant disease (6) Subjects with low (10×103/µL) white blood cell counts, a key indicator of immune function (7) Subjects taking medications for depression or other psychiatric disorders (8) Pregnant or lactating women, or women of childbearing age who have not consented to contraception (9) Subjects who have taken medications, antibiotics, or other probiotics that may affect gastrointestinal motility within the past two weeks (10) Subjects who have participated in another clinical trial within the past two weeks (11) Subjects deemed unsuitable for this study by the investigator

Design outcomes

Primary

Measure	Time frame
=50-point reduction in the IBS-SSS score	—

Secondary

Measure	Time frame
Changes in SGA;improved BSS and decreased bowel frequency ;reduced abdominal pain and bloating/flatulence (VAS);bowel sensitivity and quality of life indices	—

Countries

Korea, Republic of

Contacts

Public ContactYeon Sil Jang

Samsung Medical Center

ys.jang@skku.edu+82-2-3410-6476

Outcome results