Probiotics in Patients With Primary Sclerosing Cholangitis

• Status: Unknown status
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

PSC is a progressive liver disease without effective medical treatment. There is often co-existent ulcerative colitis. Probiotics (bacterial food supplements) have been shown to benefit patients with ulcerative colitis. In the current protocol potential beneficial effects of probiotics on liver biochemistry and liver related symptoms as pruritus are being assessed in 12 PSC patients in a randomized controlled cross over study (3 months probiotics, 1 one wash-out and 3 months placebo).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UMC Utrecht

Criteria

Inclusion Criteria:

• Diagnosis of PSC based on characteristic findings on cholangiography, or based on the triad: typical histological findings in a liver biopsy, elevated serum alkaline phosphatase and presence of inflammatory bowel disease

• Presence of inflammatory bowel disease

• elevated serum alkaline phosphatase

• age ≥ 18 years

• informed consent

Exclusion Criteria:

• Pregnancy

• use of probiotics within one month before the study

• use of antibiotics within one month before the study

• a history of bacterial cholangitis