Effect of Combining Laxatives and Probiotics in Maintenance DIALysis Patients with Constipation. -A multicenter prospective observational Study- (DIAL Study)

Effect of Combining Laxatives and Probiotics in Maintenance DIALysis Patients with Constipation. -A multicenter prospective observational Study- (DIAL Study) - Effect of Combining Laxatives and Probiotics in Maintenance DIALysis Patients with Constipation. -A multicenter prospective observational Study- (DIAL Study)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053731

Enrollment

Registered

2024-03-01

Start date

2024-03-15

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Maintenance Hemodialysis Patients

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who are at least 20 years old at the time of obtaining consent. (2) Patients who have been on maintenance hemodialysis therapy for at least 3 months. (3) Patients taking laxatives (including abortive medication). (4) Individuals who can commit to not starting any new probiotics or laxatives (including OTC) other than Biothree Combination OD Tablets during the 8-week (+/-3 days) constipation treatment period of this study.

Exclusion criteria

Exclusion criteria: (1) Patients who have taken Biothree (any dosage form) within 1 month of consent. (2) Patients with or suspected to have abnormal recto-anal function. (3) Patients with organic abnormality that causes constipation indicated by colonoscopy within 5 years. (4) Patients with a history of surgical resection of the stomach, gall bladder, small intestine, or colon (excluding appendicitis and benign polypectomy). (5) Patients with obvious mechanical obstruction (intestinal obstruction due to hernia, etc.), giant colon, or giant rectum. (6) Patients with infection or signs of infection within 1 week of obtaining consent. (7) Patients with inflammatory diseases or signs of inflammatory diseases as complications. (8) Patients with autoimmune disease as a complication. (9) Patients with a history of hypersensitivity to any of the ingredients of Biosley OD Tablets. (10) Patients using spherical adsorbed charcoal (Cremezin, etc.), granulocyte colony-forming stimulating factor (G-CSF), or systemic steroids. (11) Other patients deemed inappropriate as research subjects by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Change value in Modified CSS (Constipation Severity Score) total score before and 8 weeks after treatment.	—

Countries

Japan

Contacts

Public ContactHiromu Katsta

Re-Life.inc Clinical Development Division

hkatsuta@relife-inc.com03-5958-0077

Outcome results