Nutritional Impact of Serum-Derived Bovine Immunoglobulin Protein Isolate in Subjects With IPAA
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|ClinicalTrials.gov Identifier: NCT02828410|
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : August 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pouchitis Irritable Pouch Syndrome||Dietary Supplement: SBI||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Serum bovine immunoglobulin protein isolate (SBI)
Dietary Supplement: SBI
Serum bovine immunoglobulin protein isolate 10 g twice per day
Other Name: EnteraGam
- BMI [ Time Frame: 6 months ]
- Pre-albumin [ Time Frame: 6 months ]
- Albumin [ Time Frame: 6 months ]
- Vitamin D [ Time Frame: 6 months ]
- Vitamin B12 [ Time Frame: 6 months ]
- Ferritin [ Time Frame: 6 months ]
- Short Inflammatory Bowel Disease Quality of Life Score [ Time Frame: 6 months ]
- Cleveland Global Quality of Life Score [ Time Frame: 6 months ]
- Nocturnal Bowel Movements [ Time Frame: 6 months ]Average number of nightly nocturnal bowel movements over the past week
- Concomitant Medications [ Time Frame: 6 months ]
- Abdominal Cramping [ Time Frame: 6 months ]Number of days experiencing abdominal cramping over the past week
- Consistency of Bowel Movements [ Time Frame: 6 months ]Average Bristol Stool Scale score for bowel movements during the previous week
- Incontinence [ Time Frame: 6 Months ]Number of incontinence episodes over the past week
- ESR [ Time Frame: 6 Months ]Sedimentation Rate
- CRP [ Time Frame: 6 Months ]C-reactive protein
- Fecal calprotectin [ Time Frame: 6 Months ]
- Alpha-1-antitrypsin [ Time Frame: 6 Months ]
- Number of Bowel Movements [ Time Frame: 6 Months ]Average number of daily bowel movements over the past week
- Fecal Urgency [ Time Frame: 6 Months ]Average number of days with fecal urgency over the past week
- Modified Pouchitis Disease Activity Index Score [ Time Frame: 6 Months ]When applicable
- Rectal Bleeding [ Time Frame: 6 Months ]Average number of days with rectal bleeding over the past week
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 ClinicalTrials.gov identifier (NCT number): NCT02828410
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Francis Farraye, MD||Boston Medical Center|