Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA
Condition: Pouchitis; Irritable Pouch Syndrome
MeSH terms: Pouchitis
Study type: Interventional

Summary: 
      This is an open label trial 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 description: 
      This is an open-label study involving patients who are status post ileal pouch-anal
      anastomosis age 18 and 75 who receive care at Boston Medical Center's Center for Digestive
      Disorders (CDD). There is no randomization or use of placebo in this study and patients will
      be recruited sequentially. This is an open-label, single center study evaluating the
      effectiveness of SBI or EnteraGam (10.0 g twice per day) on nutritional status and quality of
      life in patients with ileal pouch-anal anastomosis.

      Nutritional status and inflammation be assessed by measuring CBC with differential, vitamin
      D, vitamin B12, pre-albumin, albumin, ferritin, ESR, CRP, alpha-1-antitrypsin, and fecal
      calprotectin levels at screening, Day 84, and Day 168. Stool samples from these same time
      points will also be frozen and stored until the end of the study for potential fecal
      microbiome analysis depending on the results of other outcome measures.

      The effect of SBI on a subject's quality of life (QoL) will be evaluated using the Short
      Inflammatory Bowel Disease Questionnaire and Cleveland Global Quality of Life scores at
      baseline, Day 28, Day 84, and End of Study.

      The short form of disease specific QoL (s-IBDQ) includes 10 questions derived from the 32
      questions IBDQ concerning QoL. It covers four items: bowel symptoms, systemic symptoms,
      emotional, and social functions. The total score ranges from 10 (worst health) to 70 (best
      health).

      The Cleveland Global Quality of Life (CGOL) score is an instrument specifically designed for
      patients with ileal pouches. Subjects will be asked to rate each of three items (current QOL,
      current quality of health, and current energy level) on a scale of 0-10, 0 being the worst
      and 10 the best. The sum of the three scores divided by 30 will provide the CGQL score.

      The Modified Pouchitis Disease Activity Index (mPDAI) will be used to evaluate for pouchitis
      and assess the overall disease activity for each subject at baseline pouchoscopy. This
      modified diagnostic instrument consists of two component scores: clinical symptoms (range 0-6
      points) and endoscopic appearence (range 0-6 points). Follow-up pouchoscopy is not part of
      the study protocol. However, if a patient warrants follow-up pouchoscopy at any point during
      the study period based on standard of care (most likley due to worsening or non-responsive
      symptoms), then the mPDAI at follow-up pouchoscopy will also be calculated and included in
      outcomes analysis.
    

Intervention name(s): SBI
Intervention type(s): Dietary Supplement
Intervention description(s): Serum bovine immunoglobulin protein isolate 10 g twice per day
Other intervention name(s): EnteraGam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: serum bovine immunoglobulin protein isolate; IPAA; quality of life