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

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ClinicalTrials.gov Identifier: NCT02953691
Recruitment Status : Withdrawn (Lack of Study Substance)
First Posted : November 3, 2016
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Jeff Taekman, M.D., Duke University

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.

Condition or disease Intervention/treatment Phase
Anxiety Pain Surgery Drug: Galacto-Oligosaccharide Drug: Maltodextrin (Placebo) Phase 2

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Exploring the Impact of Perioperative Galacto-Oligosaccharides (GOS) on Stress, Anxiety and Cognition
Actual Study Start Date : June 9, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Galacto-Oligosaccharides (GOS)
Clasado Biosciences Limited will provide Bimuno Pastilles for the clinical trial. Each pastille contains 0.92g GOS and will be taken 3 times per day. Following informed consent, subjects will be issued prepackaged GOS pastilles to be taken three times daily up until the evening prior to surgery. Subjects will be randomly assigned to receive GOS prebiotics. Each subject has an equal chance of receiving GOS or placebo. GOSn will be administered in the hospital when patient reinstitutes oral intake. GOS will be issued to each subject to last until the day of their scheduled follow-up for POCD (approximately 1.5 months post surgery).
Drug: Galacto-Oligosaccharide
Mixture produced from lactose utilizing the transgalactosidic activity of Bifidobacterium bifidum NCIMB 41171 beta-galactosidase

Placebo Comparator: Maltodextrin (Placebo)
Clasado Biosciences Limited will provide placebo (Maltodextrin) for the clinical trial. Each pastille contains maltodextrin and will be taken 3 times per day. Following informed consent, subjects will be issued prepackaged pastilles to be taken three times daily up until the evening prior to surgery. Subjects will be randomly assigned to receive GOS prebiotics or placebo. Each subject has an equal chance of receiving GOS or placebo. Placebo will be administered in the hospital when patient reinstitutes oral intake. Placebo will be issued to each subject to last until the day of their scheduled follow-up for POCD (approximately 1.5 months post surgery).
Drug: Maltodextrin (Placebo)
Maltodextrin is a polysaccharide commonly used as a food additive. It is produced from starch by partial hydrolysis.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Changes in pain perception [ 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 ]
    Collected through Visual Analog Scale.

  2. Changes in cognition [ Time Frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit ]
    Hopkins Verbal Learning Test - Revised (HVLT-R)

  3. Changes in perceived stress [ Time Frame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit ]
    Subjects will complete web-based versions of the State-Trait Anxiety Scale.

  4. Changes in perceived stress [ Time Frame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit ]
    Subjects will complete web-based versions Hospital Anxiety and Depression Scale-HADS.

  5. Changes in perceived stress [ 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 ]
    Subjects will complete web-based versions Visual Analog Anxiety Scale.

  6. Changes in cognition [ Time Frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit ]
    Randt Short Story Memory Test

  7. Changes in cognition [ Time Frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit ]
    Modified Visual Reproduction Test from the Wechsler Memory Scale

  8. Changes in cognition [ Time Frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit ]
    Weschsler Adult Intelligence Scale - Revised (WAIS-R)

  9. Changes in cognition [ Time Frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit ]
    Trail Making Test

  10. Changes in cognition [ Time Frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit ]
    Grooved Pegboard

  11. Changes in cognition [ Time Frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit ]
    Mini Mental Status Exam (MMSE)

  12. Suicidal ideation and behavior [ Time Frame: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit ]
    Columbia-Suicide Severity Rating Scale (C-SSRS)



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953691


Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Jeff Taekman, M.D.
Investigators
Principal Investigator: Jeffrey M Taekman, M.D. Duke University

Publications:
Responsible Party: Jeff Taekman, M.D., Professor of Anesthesiology, Duke University
ClinicalTrials.gov Identifier: NCT02953691     History of Changes
Other Study ID Numbers: Pro00075000
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jeff Taekman, M.D., Duke University:
perioperative
surgery
pain
anxiety
post operative cognitive dysfunction
cognition

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders