The overall objective of this proposal is to explore the association between the administration of the prebiotics GOS (trade name: Bimuno Travelaid; generic name:B galacto-oligosaccharides) with pain, anxiety, and cognitive function in the perioperative period. The investigators' central hypothesis is subjects who consume GOS in the perioperative period will demonstrate lower levels of salivary cortisol before, during, and after their operative procedures. In addition, the investigators expect subjects who consume GOS to have lower perceived levels of anxiety during the perioperative period. Finally, the investigators hypothesize that subjects who consume perioperative GOS will perform better on tests of cognition in the postoperative period. Such a finding would be beneficial in that administration of GOS in the perioperative period offers a safe and inexpensive adjunct to current medical management of perioperative anxiety.
AIM 1: In anterior cervical decompression and fusion (ACDF) subjects, explore the association between prebiotics, anxiety, and pain. Studies have recently elucidated a link between certain prebiotics and lower perceived anxiety as well as biomarkers of stress. In this aim the investigators will explore the association between consumption of prebiotics and their relationship to perioperative anxiety / physiological stress response. The investigators hypothesize that subjects who receive prebiotics will have lower perioperative anxiety and stress versus control as measured by standardized surveys and biomarkers. Furthermore, the investigators hypothesize that lower anxiety will result in lower postoperative pain scores. AIM 2: In ACDF patients, explore the association between GOS and post-operative cognitive dysfunction. Stress and anxiety is known to impair cognitive function. In addition, in preclinical studies, the administration of distinct keystone bacterial strains improves cognitive function in an anxious mouse model. In humans, prebiotics and probiotics have been shown to ameliorate the stress response. In this aim the investigators seek to explore the association between prebiotics and perioperative cognitive outcomes in humans. The investigators will perform cognitive function testing using the same time-tested battery used in the department to study post-operative cognitive decline (POCD). Subjects will be tested for cognitive function preoperatively (T1) and at 1.5 months post-op (T4). The investigators hypothesize that patients receiving prebiotics during the perioperative period will show less post-operative cognitive dysfunction than controls. A total of 8 subjects will be recruited from the Neurosurgery Clinics of Duke University Health System. The target population will include subjects undergoing ACDF. Exclusion criteria will include: pregnant women, age\<21 years, a diagnosis of depression, mental or behavioral disorder, recent anxiolytic use, long-term opiate use, oral contraceptive use, or recent antibiotic use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Mixture produced from lactose utilizing the transgalactosidic activity of Bifidobacterium bifidum NCIMB 41171 beta-galactosidase
Maltodextrin is a polysaccharide commonly used as a food additive. It is produced from starch by partial hydrolysis.
Duke University Medical Center
Durham, North Carolina, United States
Change in Waking Salivary Cortisol
Time frame: Morning after Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6-week follow-up visit
Changes in pain perception
Collected through Visual Analog Scale.
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 30 minutes after surgery, 1-day after surgery, 6 week follow-up visit
Changes in cognition
Hopkins Verbal Learning Test - Revised (HVLT-R)
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in perceived stress
Subjects will complete web-based versions of the State-Trait Anxiety Scale.
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit
Changes in perceived stress
Subjects will complete web-based versions Hospital Anxiety and Depression Scale-HADS.
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit
Changes in perceived stress
Subjects will complete web-based versions Visual Analog Anxiety Scale.
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 30 minutes after surgery, 1-day after surgery, 6 week follow-up visit
Changes in cognition
Randt Short Story Memory Test
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Modified Visual Reproduction Test from the Wechsler Memory Scale
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Weschsler Adult Intelligence Scale - Revised (WAIS-R)
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Trail Making Test
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Grooved Pegboard
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Mini Mental Status Exam (MMSE)
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Suicidal ideation and behavior
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit
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