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

NCT02828410 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2018-08-14

No results posted yet for this study

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.

Conditions

  • Pouchitis
  • Irritable Pouch Syndrome

Interventions

DIETARY_SUPPLEMENT

SBI

Serum bovine immunoglobulin protein isolate 10 g twice per day

Sponsors & Collaborators

  • Entera Health, Inc

    collaborator INDUSTRY

  • Boston Medical Center

    lead OTHER

Principal Investigators

  • Francis Farraye, MD · Boston Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02828410 on ClinicalTrials.gov