Probiotics in Patients With Primary Sclerosing Cholangitis

NCT00161148 | Unknown Phase 3

• 1 other identifier: PBPSC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Primary Sclerosing Cholangitis

Keywords

PSC; Liver biochemistry; Probiotics; Pruritus

Outcome Measures

Primary Outcomes (1)

• Assessment of the effects of treatment with probiotics on serum liver tests

Secondary Outcomes (1)

• Assessment of the effects of treatment with probiotics on fatigue and pruritus

Interventions

Probiotics DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• use of probiotics within one month before the study
• use of antibiotics within one month before the study
• a history of bacterial cholangitis

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3508 GA, Netherlands

RECRUITING

Related Publications (2)

• Liu Q, Duan ZP, Ha DK, Bengmark S, Kurtovic J, Riordan SM. Synbiotic modulation of gut flora: effect on minimal hepatic encephalopathy in patients with cirrhosis. Hepatology. 2004 May;39(5):1441-9. doi: 10.1002/hep.20194.

  PMID: 15122774 BACKGROUND

• Lindor KD. Ursodiol for primary sclerosing cholangitis. Mayo Primary Sclerosing Cholangitis-Ursodeoxycholic Acid Study Group. N Engl J Med. 1997 Mar 6;336(10):691-5. doi: 10.1056/NEJM199703063361003.

  PMID: 9041099 BACKGROUND

MeSH Terms

Conditions

Cholangitis, Sclerosing; Pruritus

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Karel v Erpecum, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karel v Erpecum, MD, PhD

CONTACT

+31 30 2506275; k.j.vanerpecum@azu.nl

Frank Vleggaar, MD, PhD

CONTACT

+ 31 30 2506275; f.vleggaar@azu.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: January 1, 2005
• Study Completion: May 1, 2006
• Last Updated: January 9, 2007

Record last verified: 2007-01

Locations

NL (1)