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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Anxiety, Pain, Surgery

In brief

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.

Key facts

Study ID

NCT02953691

Run by

Jeff Taekman, M.D.

People needed

0

Starts

2017-06-09

Expected to finish

2018-01-01

Last updated by the study team

2018-01-31

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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