Exploring the Impact of Perioperative Galacto-Oligosaccharides (GOS) on Stress, Anxiety and Cognition
| Status: | Withdrawn |
|---|---|
| Conditions: | Anxiety, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 21 - 70 |
| Updated: | 2/2/2018 |
| Start Date: | June 9, 2017 |
| End Date: | January 1, 2018 |
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.
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.
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.
Inclusion Criteria:
- Patients undergoing anterior cervical discectomy and fusion
Exclusion Criteria:
- Pregnancy
- Breast Feeding Women
- Diagnosis of Depression
- Diagnosis of mental or behavioral disorder
- Recent anxiolytic use (within 1 week of enrollment)
- Long-term opiate use (greater than 1 week prior to enrollment)
- Recent systemic steroid use (within 1 week of enrollment)
- Diagnosis of cancer
- Oral or intravenous antibiotic use within 1 month of enrollment
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