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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02828410
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : August 14, 2018
Entera Health, Inc
Information provided by (Responsible Party):
Francis Farraye, MD, Boston Medical Center

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.

Condition or disease Intervention/treatment Phase
Pouchitis Irritable Pouch Syndrome Dietary Supplement: SBI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Ileal Pouch-Anal Anastomosis
Actual Study Start Date : July 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SBI
Serum bovine immunoglobulin protein isolate (SBI)
Dietary Supplement: SBI
Serum bovine immunoglobulin protein isolate 10 g twice per day
Other Name: EnteraGam

Primary Outcome Measures :
  1. BMI [ Time Frame: 6 months ]
  2. Pre-albumin [ Time Frame: 6 months ]
  3. Albumin [ Time Frame: 6 months ]
  4. Vitamin D [ Time Frame: 6 months ]
  5. Vitamin B12 [ Time Frame: 6 months ]
  6. Ferritin [ Time Frame: 6 months ]
  7. Short Inflammatory Bowel Disease Quality of Life Score [ Time Frame: 6 months ]
  8. Cleveland Global Quality of Life Score [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Nocturnal Bowel Movements [ Time Frame: 6 months ]
    Average number of nightly nocturnal bowel movements over the past week

  2. Concomitant Medications [ Time Frame: 6 months ]
  3. Abdominal Cramping [ Time Frame: 6 months ]
    Number of days experiencing abdominal cramping over the past week

  4. Consistency of Bowel Movements [ Time Frame: 6 months ]
    Average Bristol Stool Scale score for bowel movements during the previous week

  5. Incontinence [ Time Frame: 6 Months ]
    Number of incontinence episodes over the past week

  6. ESR [ Time Frame: 6 Months ]
    Sedimentation Rate

  7. CRP [ Time Frame: 6 Months ]
    C-reactive protein

  8. Fecal calprotectin [ Time Frame: 6 Months ]
  9. Alpha-1-antitrypsin [ Time Frame: 6 Months ]
  10. Number of Bowel Movements [ Time Frame: 6 Months ]
    Average number of daily bowel movements over the past week

  11. Fecal Urgency [ Time Frame: 6 Months ]
    Average number of days with fecal urgency over the past week

  12. Modified Pouchitis Disease Activity Index Score [ Time Frame: 6 Months ]
    When applicable

  13. Rectal Bleeding [ Time Frame: 6 Months ]
    Average number of days with rectal bleeding over the past week

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02828410

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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Entera Health, Inc
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Principal Investigator: Francis Farraye, MD Boston Medical Center

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Responsible Party: Francis Farraye, MD, BMC Investigator, Boston Medical Center Identifier: NCT02828410     History of Changes
Other Study ID Numbers: H-33890
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Francis Farraye, MD, Boston Medical Center:
serum bovine immunoglobulin protein isolate
quality of life

Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Ileal Diseases
Immunologic Factors
Physiological Effects of Drugs