Exploring the Impact of Perioperative Galacto-Oligosaccharides (GOS) on Stress, Anxiety and Cognition

Pain Clinical Trial

Official title:

Exploring the Impact of Perioperative Galacto-Oligosaccharides (GOS) on Stress, Anxiety and Cognition

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02953691
• Other study ID #: Pro00075000
• Status: Withdrawn
• Phase: Phase 2
• First received: October 24, 2016
• Last updated: January 30, 2018
• Start date: June 9, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: January 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Surgery

Intervention

Drug:
• Galacto-Oligosaccharide
Mixture produced from lactose utilizing the transgalactosidic activity of Bifidobacterium bifidum NCIMB 41171 beta-galactosidase
• Maltodextrin (Placebo)
Maltodextrin is a polysaccharide commonly used as a food additive. It is produced from starch by partial hydrolysis.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Jeff Taekman, M.D.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Waking Salivary Cortisol		Morning after Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6-week follow-up visit
Secondary	Changes in pain perception	Collected through Visual Analog Scale.	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
Secondary	Changes in cognition	Hopkins Verbal Learning Test - Revised (HVLT-R)	Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Secondary	Changes in perceived stress	Subjects will complete web-based versions of the State-Trait Anxiety Scale.	Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit
Secondary	Changes in perceived stress	Subjects will complete web-based versions Hospital Anxiety and Depression Scale-HADS.	Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit
Secondary	Changes in perceived stress	Subjects will complete web-based versions Visual Analog Anxiety Scale.	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
Secondary	Changes in cognition	Randt Short Story Memory Test	Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Secondary	Changes in cognition	Modified Visual Reproduction Test from the Wechsler Memory Scale	Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Secondary	Changes in cognition	Weschsler Adult Intelligence Scale - Revised (WAIS-R)	Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Secondary	Changes in cognition	Trail Making Test	Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Secondary	Changes in cognition	Grooved Pegboard	Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Secondary	Changes in cognition	Mini Mental Status Exam (MMSE)	Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Secondary	Suicidal ideation and behavior	Columbia-Suicide Severity Rating Scale (C-SSRS)	Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit