AnxietyPhase 2NCT02953691
Exploring the Impact of Perioperative Galacto-Oligosaccharides (GOS) on Stress, Anxiety and Cognition
A Phase 2 study testing Galacto-Oligosaccharide in people with Anxiety and Pain, run by Jeff Taekman, M.D. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- What is being tested?
- Galacto-Oligosaccharide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2017to 1 Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing anterior cervical discectomy and fusion
Who cannot join
- 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)
Show all 9Show fewer
- Recent systemic steroid use (within 1 week of enrollment)
- Diagnosis of cancer
- Oral or intravenous antibiotic use within 1 month of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the 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.
- Being tested
- Galacto-Oligosaccharide, Maltodextrin (Placebo)
- Keywords
- perioperative, surgery, pain, anxiety, post operative cognitive dysfunction, cognition
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galacto-OligosaccharideDrug
Mixture produced from lactose utilizing the transgalactosidic activity of Bifidobacterium bifidum NCIMB 41171 beta-galactosidase
Maltodextrin (Placebo)Drug
Maltodextrin is a polysaccharide commonly used as a food additive. It is produced from starch by partial hydrolysis.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Drug: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Waking Salivary Cortisol
Measured: 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
Collected through Visual Analog Scale.
Measured: 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
Hopkins Verbal Learning Test - Revised (HVLT-R)
Measured: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in perceived stress
Subjects will complete web-based versions of the State-Trait Anxiety Scale.
Measured: 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
Subjects will complete web-based versions Hospital Anxiety and Depression Scale-HADS.
Measured: 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
Subjects will complete web-based versions Visual Analog Anxiety Scale.
Measured: 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
Randt Short Story Memory Test
Measured: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Modified Visual Reproduction Test from the Wechsler Memory Scale
Measured: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Weschsler Adult Intelligence Scale - Revised (WAIS-R)
Measured: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Trail Making Test
Measured: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Grooved Pegboard
Measured: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Mini Mental Status Exam (MMSE)
Measured: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Suicidal ideation and behavior
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Preop Clinic Visit (2 weeks prior to surgery), 2-hours before surgery, 1-day after surgery, 6 week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start9 Jun 2017
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Why it stopped: Lack of Study Substance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeff Taekman, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jeff Taekman, M.D., Duke University
- Investigators
- Jeffrey M Taekman, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953691
- Sponsor's protocol ID
- Pro00075000
- Status last verified
- Jan 2018
- First submitted
- 24 Oct 2016
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25449699Tillisch 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.
PubMed 24838095
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Perioperative Galacto-Oligosaccharides (GOS) on Stress, Anxiety and Cognition
- ClinicalTrials.gov ID
- NCT02953691
- Acronym / sponsor ID
- Pro00075000
- Keywords
- perioperative, surgery, pain, anxiety, post operative cognitive dysfunction, cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Study Substance
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jeff Taekman, M.D.University, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 3 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Galacto-Oligosaccharides (GOS) | Experimental | Drug: Galacto-OligosaccharideClasado 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). |
| Maltodextrin (Placebo) | Placebo comparator | Drug: 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). |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing anterior cervical discectomy and fusion
Key exclusion criteria (9 listed)
- Pregnancy
- Breast Feeding Women
- Diagnosis of Depression
- Diagnosis of mental or behavioral disorder
- Recent anxiolytic use (within 1 week of enrollment)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galacto-OligosaccharideMixture produced from lactose utilizing the transgalactosidic activity of Bifidobacterium bifidum NCIMB 41171 beta-galactosidase | Drug | Galacto-Oligosaccharides (GOS) |
| Maltodextrin (Placebo)Maltodextrin is a polysaccharide commonly used as a food additive. It is produced from starch by partial hydrolysis. | Drug | Maltodextrin (Placebo) |
Primary outcome
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
12 secondary outcomes
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
Changes in cognition
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
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
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
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
Changes in cognition
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
Changes in cognition
Time frame: Preop Clinic Visit (2 weeks prior to surgery), 6 week follow-up visit
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Background: PubMed 25449699Schmidt 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.
- Background: PubMed 24838095Tillisch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey M Taekman, M.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Galacto-Oligosaccharide in people with Anxiety and Pain, run by Jeff Taekman, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02953691, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.