title: Casein glycomacropeptide for active distal ulcerative colitis: a randomized pilot study.
abstract: BACKGROUND
  In ulcerative colitis (UC), dietary supplements may have anti-inflammatory properties and improve disease course. We investigated the effects of casein glycomacropeptide (CGMP), a fraction of bovine whey protein, in active UC.
  
  
  METHODS
  In a randomized open-label intervention study, 24 patients with active UC involving 10-40 cm of the distal colon were randomized in a 2 : 1 ratio into two groups. The first group was administered their usual treatment plus a daily supplement of CGMP 30 g, and the second group was administered a dose escalation to 4800 mg oral mesalamine daily (standard treatment) for 4 weeks. Clinical, endoscopic, mucosal and circulating disease activity markers were monitored. Acceptance of and adherence to CGMP up to 8 weeks were documented.
  
  
  RESULTS
  After 4 weeks of treatment, 10 of 16 (63%) patients who received CGMP had an unchanged or decreased Simple Clinical Colitis Activity Index (SCCAI), which was similar to the four of eight (50%) (P = 0·67) patients on the standard treatment. The number of patients in which SCCAI decreased by three or more did not differ between the two groups: nine of 16 (56%) in the CGMP group vs. four of eight (50%) in the standard treatment group (P = 0·77). Changes in disease extent and severity were similar between the two groups. CGMP was well tolerated and accepted by the patients.
  
  
  CONCLUSIONS
  The addition of CGMP as a nutritional therapy to standard treatment was safe and accepted by patients with active distal UC. The disease-modifying effect of CGMP was similar to that of the mesalamine dose escalation.
authors.affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark.
authors.forename: Christian L
authors.initials: CL
authors.lastname: Hvas
authors.affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark.
authors.forename: Anders
authors.initials: A
authors.lastname: Dige
authors.affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark.
authors.forename: Mia
authors.initials: M
authors.lastname: Bendix
authors.affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark.
authors.forename: Pernille G
authors.initials: PG
authors.lastname: Wernlund
authors.affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark.
authors.forename: Lisbet A
authors.initials: LA
authors.lastname: Christensen
authors.affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark.
authors.forename: Jens F
authors.initials: JF
authors.lastname: Dahlerup
authors.affiliation: Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus C, Denmark.
authors.forename: Jørgen
authors.initials: J
authors.lastname: Agnholt
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D002364:Caseins / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D019587:Dietary Supplements; D005260:Female; D006020:Glycopeptides / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use; D008875:Middle Aged; D010865:Pilot Projects; D012002:Rectal Diseases / Q000188:drug therapy*; D012720:Severity of Illness Index; D012810:Sigmoid Diseases / Q000188:drug therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D002364:Caseins; D006020:Glycopeptides; C020251:kappa-casein glycomacropeptide; D019804:Mesalamine
keywords: Casein glycomacropeptide; clinical trial; inflammatory bowel diseases; ulcerative colitis