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Proof-of-concept clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1

Proof-of-concept clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1 - LEAC study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000030327
Enrollment
8
Registered
2017-12-22
Start date
2017-12-25
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

Nonspecific multiple ulcers in the small intestine unrelated to NSAID (Chronic enteropathy associated with SLCO2A1: CEAS)

Interventions

lubiprostone(12 micrograms) for 8 weeks

Sponsors

Fujita Health University, Department of Gastroenterology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with CEAS who provide informed consent.

Exclusion criteria

Exclusion criteria: 1) Contraindications of enteroscopy 2) Bad conditions such as small bowel obstruction 3) Severe cardiac or pulmonary disease 4) Allergy to lubiprostone or contraindications of lubiprostone 5) Within 1 month of another clinical trial 6) Pregnant or lactating women 7) Man or woman who does not comply with this trial 8) Inappropriate situations judged by attending doctors

Design outcomes

Primary

MeasureTime frame
1) Enteroscopic improvement after lubiprotone treatment 2) Endocmicroscopic improvement of leaky gut syndrome—

Secondary

MeasureTime frame
1)Serum iron, ferritin, total protein, and albumin 2) Urine PGE-MUM/Cr 3) Fecal calprotectin 4) Oter blood test data 5) Symptomatic improvement 6) Pathologic change 7) Bowel movements—

Countries

Japan

Contacts

Public ContactNaoki Ohmiya

Fujita Health University Department of Gastroenterology

nohmiya@fujita-hu.ac.jp0562-93-9240

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026