Abstract
Background
Patients with irritable bowel syndrome (IBS) or inflammatory bowel disease (IBD) commonly experience diarrhea, abdominal pain, bloating, and urgency. These symptoms significantly compromise the patient’s quality of life (QoL) by limiting participation in normal daily activities and adversely affect work productivity and performance.
Purpose
The aim of this study was to understand from the patient’s perspective how oral serum-derived bovine immunoglobulin/protein isolate (SBI) impacts bowel habits, management of condition, and basic QoL.
Methods
A 1-page questionnaire was distributed randomly to >14,000 patients who were prescribed SBI (EnteraGam®) for relevant intended uses. The survey was designed to collect data related to the influence of IBS or IBD on daily life activities and the impact of SBI usage on daily stool frequency, management of their condition, and QoL. Patient-reported responses were analyzed using a paired t-test to compare mean change in daily stool output and descriptive statistics for continuous variables.
Results
A total of 1,377 patients returned the surveys. Results from 595 surveys were analyzed with a focus on patients with IBS or IBD who had provided numeric responses regarding daily stool frequency. Respondents with IBS who reported having a normal stool frequency (≤4 stools per day) increased from 35% prior to using SBI to 91% while using SBI. A similar change toward normal stool frequency was reported by IBD respondents. Mean daily stool numbers decreased for respondents in the combined IBS and IBD groups (P=0.0001) from 6.5±4.3 before SBI to 2.6±1.9 following SBI use. The majority of respondents agreed strongly or very strongly that SBI helped them manage their condition (66.9%) and helped them return to the activities they enjoyed (59.1%).
Conclusion
Results from this patient survey suggest that SBI use can lead to clinically relevant decreases in daily stool frequency in patients with IBS or IBD along with improvements in the overall management of their condition and aspects of QoL.
Acknowledgments
The authors thank Linda Gordon and James Martin for their role in the design and development of this survey project. The authors also thank Brooke Jackson for collection and data entry of patient surveys and Janice Gleavy for her contributions in the writing of this manuscript. Financial sources: this study was funded by Entera Health Inc., 2000 Regency Parkway, Suite 255, Cary, NC 27518, USA.
Author contributions
ALS and BPB also participated in the development and execution of this survey. ALS, BWP, and BPB supervised and managed the collection and analysis of data; AT conducted statistical analysis of data; ALS, TPB, BWP, and BPB analyzed and interpreted the data. BWP, TPB, and ALS also participated in writing and critical review of the manuscript for publication. All authors contributed toward data analysis, drafting and critically revising the paper and agree to be accountable for all aspects of the work.
Disclosure
ALS, TPB, BWP, and BPB are former employees of Entera Health, Inc. AT reports no conflicts of interest in this work.