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

Completed · Not applicable

Conditions studied: Pouchitis, Irritable Pouch Syndrome

In brief

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.

Key facts

Study ID

NCT02828410

Run by

Boston Medical Center

People needed

6

Starts

2016-07-01

Expected to finish

2018-06-01

Last updated by the study team

2018-08-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is male or female between the ages of 18-75 years, inclusive.
• Patient has history of UC or Crohn's disease (CD) diagnosed by standard clinical, radiographic, endoscopic, and histopathological criteria.
• Patient has undergone total proctocolectomy and IPAA surgery a minimum of 6 months prior to screening.
• Patient has symptoms suggestive of pouchitis including frequent bowel movements of greater than or equal to seven per day (≥7 per day), and one or more of the following: daily rectal bleeding, fecal urgency, abdominal cramps, or fever >37.8oC).
• Patient is capable of understanding the requirements of the study and has signed / dated an IRB approved informed consent form.

You may not qualify if…

• Patient cannot or will not provide written informed consent.
• Patient has a known allergy or hypersensitivity to beef, beef products, or any ingredient used in EnteraGam.
• Patient has clinical signs and symptoms of an active infection.
• Patient is on antibiotic therapy (other than for pouchitis treatment) at any time in the 30 days prior to screening.
• Patient has active alcohol or drug abuse or psychiatric disorders felt to preclude his / her ability to complete the study.
• Patient who, in the opinion of the investigator, has a poorly controlled / uncontrolled significant medical condition that would interfere with the study.
• Positive stool test (PCR) for C. difficile.
• Use of antidiarrheal medications (ADM). - Exception: patients who, in the opinion of the Investigator, are on stable treatment with ADMs may be enrolled provided that the administration schedule is intended to be maintained or decreased during the study and the subject has been on stable treatment with ADMs for at least 30 days prior to screening; otherwise, these agents are prohibited in the study.
• Use of an investigational product or participation in a clinical trial within the past three months.
• Use of a biologic (e.g., infliximab, adalimumab) within the last 3 months.
• Patient is pregnant or nursing.

Where it is running

• Boston Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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