Clinical trial NCT02953691: Exploring the Impact of Perioperative Galacto-Oligosaccharides (GOS) on Stress, Anxiety and Cognition
Official title: Exploring the Impact of Perioperative Galacto-Oligosaccharides (GOS) on Stress, Anxiety and Cognition
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Anxiety
Pain
Surgery
Keywords: perioperative
surgery
pain
anxiety
post operative cognitive dysfunction
cognition
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-11-03
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Waking Salivary Cortisol
timeFrame: Morning after Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6-week follow-up visit
Secondary outcomes:
measure: Changes in pain perception
timeFrame: 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
measure: Changes in cognition
timeFrame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
measure: Changes in perceived stress
timeFrame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit
measure: Changes in perceived stress
timeFrame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit
measure: Changes in perceived stress
timeFrame: 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
measure: Changes in cognition
timeFrame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
measure: Changes in cognition
timeFrame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
measure: Changes in cognition
timeFrame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
measure: Changes in cognition
timeFrame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
measure: Changes in cognition
timeFrame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
measure: Changes in cognition
timeFrame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
measure: Suicidal ideation and behavior
timeFrame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Jeffrey M Taekman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schmidt K, Cowen PJ, Harmer CJ, Tzortzis G, Errington S, Burnet PW. Prebiotic intake reduces the waking cortisol response and alters emotional bias in healthy volunteers. Psychopharmacology (Berl). 2015 May;232(10):1793-801. doi: 10.1007/s00213-014-3810-0. Epub 2014 Dec 3.
citation: Tillisch K. The effects of gut microbiota on CNS function in humans. Gut Microbes. 2014 May-Jun;5(3):404-10. doi: 10.4161/gmic.29232. Epub 2014 May 16.