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PouchitisNCT02828410

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

A study testing SBI in people with Pouchitis and Irritable Pouch Syndrome, run by Boston Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pouchitis, Irritable Pouch Syndrome
What is being tested?
SBI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
Jul 2016to Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Medical Center

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: Evaluating the Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With Ileal Pouch-Anal Anastomosis

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.

Read the 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.

Being tested
SBI
Keywords
serum bovine immunoglobulin protein isolate, IPAA, quality of life
Medical subject headings
Pouchitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBIDietary supplement

    Also called EnteraGam

    Serum bovine immunoglobulin protein isolate 10 g twice per day

Study groups in NCT02828410
Study groupRoleWhat they receive
SBIExperimentalSerum bovine immunoglobulin protein isolate (SBI)
Receives: Dietary Supplement: SBI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI

    Measured: 6 months

  2. Pre-albumin

    Measured: 6 months

  3. Albumin

    Measured: 6 months

  4. Vitamin D

    Measured: 6 months

  5. Vitamin B12

    Measured: 6 months

  6. Ferritin

    Measured: 6 months

  7. Short Inflammatory Bowel Disease Quality of Life Score

    Measured: 6 months

  8. Cleveland Global Quality of Life Score

    Measured: 6 months

Secondary outcomes (13)

  1. Nocturnal Bowel Movements

    Average number of nightly nocturnal bowel movements over the past week

    Measured: 6 months

  2. Concomitant Medications

    Measured: 6 months

  3. Abdominal Cramping

    Number of days experiencing abdominal cramping over the past week

    Measured: 6 months

  4. Consistency of Bowel Movements

    Average Bristol Stool Scale score for bowel movements during the previous week

    Measured: 6 months

  5. Incontinence

    Number of incontinence episodes over the past week

    Measured: 6 Months

  6. ESR

    Sedimentation Rate

    Measured: 6 Months

  7. CRP

    C-reactive protein

    Measured: 6 Months

  8. Fecal calprotectin

    Measured: 6 Months

  9. Alpha-1-antitrypsin

    Measured: 6 Months

  10. Number of Bowel Movements

    Average number of daily bowel movements over the past week

    Measured: 6 Months

  11. Fecal Urgency

    Average number of days with fecal urgency over the past week

    Measured: 6 Months

  12. Modified Pouchitis Disease Activity Index Score

    When applicable

    Measured: 6 Months

  13. Rectal Bleeding

    Average number of days with rectal bleeding over the past week

    Measured: 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2016 (estimated)
  2. Study startJul 2016
  3. Primary completionJun 2017
  4. Study completionJun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02828410
Sponsor's protocol ID
H-33890
Status last verified
Aug 2018
First submitted
2 Jul 2016
Last updated
14 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SBI in people with Pouchitis and Irritable Pouch Syndrome, run by Boston Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI (time frame: 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02828410.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.

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