NCT02953691

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_2 anxiety

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

June 9, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

7 months

First QC Date

October 24, 2016

Last Update Submit

January 30, 2018

Conditions

AnxietyPainSurgery

Keywords

perioperativesurgerypainanxietypost operative cognitive dysfunctioncognition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Changes in pain perception

    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

  • Changes in cognition

    Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit

  • Changes in perceived stress

    Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit

  • Changes in perceived stress

    Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit

  • Changes in perceived stress

    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

  • +7 more secondary outcomes

Study Arms (2)

Galacto-Oligosaccharides (GOS)

EXPERIMENTAL

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

Maltodextrin (Placebo)

PLACEBO COMPARATOR

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)

Interventions

Galacto-OligosaccharideDRUG

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

Galacto-Oligosaccharides (GOS)
Maltodextrin (Placebo)DRUG

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

Maltodextrin (Placebo)

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing anterior cervical discectomy and fusion

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related 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.

    PMID: 25449699BACKGROUND

  • 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.

    PMID: 24838095BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPain

Interventions

4'-galactooligosaccharidemaltodextrin

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey M Taekman, M.D.

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

October 24, 2016

First Posted

November 3, 2016

Study Start

June 9, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 31, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)