NCT02828410

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

July 2, 2016

Last Update Submit

August 13, 2018

Conditions

PouchitisIrritable Pouch Syndrome

Keywords

serum bovine immunoglobulin protein isolateIPAAquality of life

Outcome Measures

Primary Outcomes (8)

  • BMI

    6 months

  • Pre-albumin

    6 months

  • Albumin

    6 months

  • Vitamin D

    6 months

  • Vitamin B12

    6 months

  • Ferritin

    6 months

  • Short Inflammatory Bowel Disease Quality of Life Score

    6 months

  • Cleveland Global Quality of Life Score

    6 months

Secondary Outcomes (13)

  • Nocturnal Bowel Movements

    6 months

  • Concomitant Medications

    6 months

  • Abdominal Cramping

    6 months

  • Consistency of Bowel Movements

    6 months

  • Incontinence

    6 Months

  • +8 more secondary outcomes

Study Arms (1)

SBI

EXPERIMENTAL

Serum bovine immunoglobulin protein isolate (SBI)

Dietary Supplement: SBI

Interventions

SBIDIETARY_SUPPLEMENT

Serum bovine immunoglobulin protein isolate 10 g twice per day

Also known as: EnteraGam
SBI

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Pouchitis

Condition Hierarchy (Ancestors)

IleitisEnteritisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesIleal Diseases

Study Officials

  • Francis Farraye, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BMC Investigator

Study Record Dates

First Submitted

July 2, 2016

First Posted

July 11, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

August 14, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)