Effects of propionyl-L-carnitine topical irrigation in distal ulcerative colitis: a preliminary report.
OBJECTIVE
To study the tolerability of propionyl-L-carnitine administered as rectal irrigation and its efficacy in improving the clinical picture of distal ulcerative colitis.


METHODS
Ten male subjects (aged 18 to 55 years, with a body mass index ranging from 21 to 25 Kg/m2) with distal ulcerative colitis were treated with propionyl-L-carnitine enemas (6 g in 200 mL physiological solution) twice a day over 120 minutes each. All subjects had a disease activity index from 0 to 1. A clinical, laboratory, endoscopy and biopsy evaluation was performed at baseline and 14 days after treatment. Serum tumor necrosis factor-alpha and interleukin-2 concentration was measured.


RESULTS
No side effects were reported by the entire patient population and the clinical conditions remained constant throughout the study period. The disease activity index improved significantly between the beginning and the end of the study in 80% of the patients. Histologic features (mucosal erosion, distortion of crypt architecture, inflammation and lamina propria gap) significantly improved in all treated patients. Serum interleukin-2 levels did not change significantly after propionyl-L-carnitine treatment (respectively: 14.7 +/- 15.8 before vs. 9.9 +/- 13.2 pg/mL), while tumor necrosis factor-alpha levels were undetectable both before and after propionyl-L-carnitine administration.


CONCLUSIONS
The topical treatment with a new formulation containing propionyl-L-carnitine seems to be safe and effective in improving the histologic features in patients with inactive or mild ulcerative colitis, as an alternative to conventional therapy.
Institute of Internal Medicine, Catholic University-Policlinico A. Gemelli Largo Gemelli, 8-00168 Roma, Italy. ggasbarrini@rm.unicatt.it
G
G
Gasbarrini
G
G
Mingrone
A
A
Giancaterini
A
A
De Gaetano
A
A
Scarfone
E
E
Capristo
M
M
Calvani
V
V
Caso
A V
AV
Greco
D000328:Adult; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D001823:Body Composition; D002331:Carnitine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000032:analysis; D008297:Male; D008875:Middle Aged; D007507:Therapeutic Irrigation; D014409:Tumor Necrosis Factor-alpha / Q000032:analysis
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007376:Interleukin-2; D014409:Tumor Necrosis Factor-alpha; C003223:propionylcarnitine; D002331:Carnitine