NCT02649075.

Methods	Study design: RCT Setting: multicentre
Participants	7 adults
Interventions	IG: serum‐derived bovine immunoglobulin (SBI) 10 g twice daily compared to matching placebo for 12 weeks followed by a 12‐week open‐label extension SBI 10 g twice daily CG: placebo
Outcomes	Starting date: February 2016 Estimated completion date: August 2017 Outcomes: Primary Change in the number of liquid and soft stools [ Time Frame: 12 weeks ] Change in abdominal pain intensity score [ Time Frame: 12 weeks ] Change in faecal calprotectin [ Time Frame: 12 weeks ] Change in CRP [ Time Frame: 12 weeks ] Change in CDAI [ Time Frame: 12 weeks ] Change in plasma albumin levels [ Time Frame: 12 weeks ] Change in body mass index [ Time Frame: 12 weeks ] Change in weight [ Time Frame: 12 weeks ] Change in quality of life (SF‐36) [ Time Frame: 12 weeks ] Secondary Assess the incidence of adverse events and serious adverse events [ Time Frame: 12 and 24 weeks ] Measure clinically significant changes from baseline in vital signs [ Time Frame: 12 and 24 weeks ] Clinically significant changes from baseline in laboratory testing [ Time Frame: 12 and 24 weeks ]
Notes	Funding: Entera Health, Inc Contact: Audrey.Shaw@enterahealth.com Our email went undelivered, and our further attempts to identify contact information were unsuccessful, therefore we were unable to determine whether this study meets our inclusion criteria.