PMID- 24914504
OWN - NLM
STAT- MEDLINE
DCOM- 20170214
LR  - 20240323
IS  - 1536-3686 (Electronic)
IS  - 1075-2765 (Print)
IS  - 1075-2765 (Linking)
VI  - 24
IP  - 1
DP  - 2017 Jan/Feb
TI  - Prospective Clinical Trial of Rifaximin Therapy for Patients With Primary 
      Sclerosing Cholangitis.
PG  - e56-e63
LID - 10.1097/MJT.0000000000000102 [doi]
AB  - Primary sclerosing cholangitis (PSC) is a rare, chronic, cholestatic liver 
      disease in which emerging data suggest that oral antibiotics may offer 
      therapeutic effects. We enrolled patients with PSC in a 12-week, open-label pilot 
      study to investigate the efficacy and safety of 550 mg of oral rifaximin twice 
      daily. The primary end point was serum alkaline phosphatase (ALK) at 12 weeks. 
      Secondary end points included (1) serum bilirubin, gamma-glutamyl transpeptidase, 
      and Mayo PSC risk score; (2) fatigue impact scale, chronic liver disease 
      questionnaire, and short form health survey (SF-36) scores; and (3) adverse 
      effects (AEs). Analyses were performed with nonparametric tests. Sixteen patients 
      were enrolled, among whom the median age was 40 years; 13 (81%) were male, 13 had 
      inflammatory bowel disease, and baseline ALK was 342 IU/mL (interquartile range, 
      275-520 IU/mL). After 12 weeks of treatment, there were no significant changes in 
      ALK (median increase of 0.9% to 345 IU/mL; P = 0.47) or any of the secondary 
      biochemical end points (all P > 0.05). Similarly, there were no significant 
      changes in fatigue impact scale, chronic liver disease questionnaire, or SF-36 
      scores (all P > 0.05). Three patients withdrew from the study due to AEs; 4 
      others reported mild AEs but completed the study. In conclusion, although some 
      antibiotics may have promise in treating PSC, oral rifaximin, based on the 
      results herein, seems inefficacious for this indication. Future studies are 
      needed to understand how the antimicrobial spectra and other properties of 
      antibiotics might determine their utility in treating PSC.
FAU - Tabibian, James H
AU  - Tabibian JH
AD  - 1Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN; 2Center 
      for Clinical and Translational Sciences, Mayo Graduate School, Rochester, MN; 
      3Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN; 
      4Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN; and 
      5College of Health Solutions, Arizona State University, Phoenix, AZ.
FAU - Gossard, Andrea
AU  - Gossard A
FAU - El-Youssef, Mounif
AU  - El-Youssef M
FAU - Eaton, John E
AU  - Eaton JE
FAU - Petz, Jan
AU  - Petz J
FAU - Jorgensen, Roberta
AU  - Jorgensen R
FAU - Enders, Felicity B
AU  - Enders FB
FAU - Tabibian, Anilga
AU  - Tabibian A
FAU - Lindor, Keith D
AU  - Lindor KD
LA  - eng
GR  - T32 DK007198/DK/NIDDK NIH HHS/United States
PT  - Clinical Trial
PT  - Journal Article
PL  - United States
TA  - Am J Ther
JT  - American journal of therapeutics
JID - 9441347
RN  - 0 (Anti-Infective Agents)
RN  - 0 (Rifamycins)
RN  - EC 2.3.2.2 (gamma-Glutamyltransferase)
RN  - EC 3.1.3.1 (Alkaline Phosphatase)
RN  - L36O5T016N (Rifaximin)
RN  - RFM9X3LJ49 (Bilirubin)
SB  - IM
MH  - Adult
MH  - Alkaline Phosphatase/blood
MH  - Anti-Infective Agents/*therapeutic use
MH  - Bilirubin/blood
MH  - Cholangitis, Sclerosing/blood/complications/*drug therapy
MH  - Fatigue/etiology
MH  - Female
MH  - Humans
MH  - Male
MH  - Pilot Projects
MH  - Prospective Studies
MH  - Pruritus/etiology
MH  - Rifamycins/*therapeutic use
MH  - Rifaximin
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
MH  - gamma-Glutamyltransferase/blood
PMC - PMC4261045
MID - NIHMS579220
EDAT- 2014/06/11 06:00
MHDA- 2017/02/15 06:00
PMCR- 2018/01/01
CRDT- 2014/06/11 06:00
PHST- 2014/06/11 06:00 [pubmed]
PHST- 2017/02/15 06:00 [medline]
PHST- 2014/06/11 06:00 [entrez]
PHST- 2018/01/01 00:00 [pmc-release]
AID - 10.1097/MJT.0000000000000102 [doi]
PST - ppublish
SO  - Am J Ther. 2017 Jan/Feb;24(1):e56-e63. doi: 10.1097/MJT.0000000000000102.