Clinical Trial: Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Evaluating the Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Ileal Pouch-Anal Anastomosis

Brief Summary: This is an open label trail to test the hypothesize that serum bovine immunoglobulin protein isolate (SBI) will improve the nutritional status and quality of life (QOL) of patients with an ileal pouch anal anastomosis (IPAA) and symptoms of pouchitis. Subjects with symptomatic IPAA will receive two packets of EnteraGam twice daily (total daily dose of 20 g SBI) for up to 24 weeks. The primary objective of this study is to determine whether SBI therapy leads to improved nutritional status and QOL. A secondary objective is to evaluate SBI in the management of their disease, including impact on clinical symptoms.

Detailed Summary:
Sponsor: Boston Medical Center

Current Primary Outcome:

  • BMI [ Time Frame: 6 months ]
  • Pre-albumin [ Time Frame: 6 months ]
  • Albumin [ Time Frame: 6 months ]
  • Vitamin D [ Time Frame: 6 months ]
  • Vitamin B12 [ Time Frame: 6 months ]
  • Ferritin [ Time Frame: 6 months ]
  • Short Inflammatory Bowel Disease Quality of Life Score [ Time Frame: 6 months ]
  • Cleveland Global Quality of Life Score [ Time Frame: 6 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Nocturnal Bowel Movements [ Time Frame: 6 months ]
    Average number of nightly nocturnal bowel movements over the past week
  • Concomitant Medications [ Time Frame: 6 months ]
  • Abdominal Cramping [ Time Frame: 6 months ]
    Number of days experiencing abdominal cramping over the past week
  • Consistency of Bowel Movements [ Time Frame: 6 months ]
    Average Bristol Stool Scale score for bowel movements during the previous week
  • Incontinence [ Time Frame: 6 Months ]
    Number of incontinence episodes over the past week
  • ESR [ Time Frame: 6 Months ]
    Sedimentation Rate
  • CRP [ Time Frame: 6 Months ]
    C-reactive protein
  • Fecal calprotectin [ Time Frame: 6 Months ]
  • Alpha-1-antitrypsin [ Time Frame: 6 Months ]
  • Number of Bowel Movements [ Time Frame: 6 Months ]
    Average number of daily bowel movements over the past week
  • Fecal Urgency [ Time Frame: 6 Months ]
    Average number of days with fecal urgency over the past week
  • Modified Pouchitis Disease Activity Index Score [ Time Frame: 6 Months ]
    When applicable
  • Rectal Bleeding [ Time Frame: 6 Months ]
    Average number of days with rectal bleeding over the past week


Original Secondary Outcome:

  • Nocturnal Bowel Movements [ Time Frame: 6 months ]
  • Concomitant Medications [ Time Frame: 6 months ]
  • Abdominal Cramping [ Time Frame: 6 months ]
  • Consistency of Bowel Movements [ Time Frame: 6 months ]
  • Incontinence [ Time Frame: 6 Months ]
  • ESR [ Time Frame: 6 Months ]
    Sedimentation Rate
  • CRP [ Time Frame: 6 Months ]
    C-reactive protein
  • Fecal calprotectin [ Time Frame: 6 Months ]
  • Alpha-1-antitrypsin [ Time Frame: 6 Months ]
  • Number of Bowel Movements [ Time Frame: 6 Months ]
  • Fecal Urgency [ Time Frame: 6 Months ]
  • Modified Pouchitis Disease Activity Index Score [ Time Frame: 6 Months ]
    When applicable
  • Rectal Bleeding [ Time Frame: 6 Months ]


Information By: Boston Medical Center

Dates:
Date Received: July 2, 2016
Date Started: July 2016
Date Completion: June 2017
Last Updated: November 9, 2016
Last Verified: November 2016