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

NCT ID: NCT02953691

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-09
• Study Completion Date: 2018-01-01

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.

Conditions

Anxiety; Pain; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Galacto-Oligosaccharide

Intervention Type: DRUG

Mixture produced from lactose utilizing the transgalactosidic activity of Bifidobacterium bifidum NCIMB 41171 beta-galactosidase

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).

Group Type: PLACEBO_COMPARATOR

Maltodextrin (Placebo)

Intervention Type: DRUG

Maltodextrin is a polysaccharide commonly used as a food additive. It is produced from starch by partial hydrolysis.

Interventions

Galacto-Oligosaccharide

Mixture produced from lactose utilizing the transgalactosidic activity of Bifidobacterium bifidum NCIMB 41171 beta-galactosidase

Intervention Type: DRUG

Maltodextrin (Placebo)

Maltodextrin is a polysaccharide commonly used as a food additive. It is produced from starch by partial hydrolysis.

Intervention Type: DRUG

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jeff Taekman, M.D.

OTHER

Sponsor Role: lead

Responsible Party

Jeff Taekman, M.D.

Professor of Anesthesiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeffrey M Taekman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25449699 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24838095 (View on PubMed)

Other Identifiers

Pro00075000

Identifier Type: -

Identifier Source: org_study_id