AzTrials
AzTrials

Obsessive-Compulsive DisorderPhase 2FOCUSEDNCT05720793

A Clinical Trial of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder

A Phase 2 study testing FMT Capsule + SIMBA Capsule in people with Obsessive-Compulsive Disorder, run by Valerie Taylor at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Obsessive-compulsive disorder (OCD) is a psychiatric condition marked by recurrent intrusive thoughts (obsessions) and ritualistic behaviors aimed at reducing distress (compulsions). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Obsessive-Compulsive Disorder
What is being tested?
FMT Capsule + SIMBA Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteCanada
Study dates
1 Jun 2023to 30 Aug 2024
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults who have a primary diagnosis of OCD
  • on a stable appropriate dose of (SSRI) treatment for at least 12 weeks prior to Baseline
  • insufficient response to current SSRI treatment indicated by persistence of symptoms.

Who cannot join

  • Participant meets Diagnostic criteria for substance use, eating disorder, schizophrenia, or schizoaffective disorder
  • Suicidality
  • regular intake of antibiotics, prebiotics, or probiotics
  • Clinically diagnosed with IBD, Crohn's disease, Ulcerative colitis, or Celiac disease
  • Immune suppression
  • intestinal obstruction
Show all 9Show fewer
  • Oropharyngeal dysphagia or other swallowing disorder
  • < 2 bowel movements per week
  • Breastfeeding, pregnant or seeking to get pregnant during the course of this study

Trial locations and contacts

1 site in 1 country.

Asem Bala, Msc, CCRP contact

4032107282

asem.bala@ucalgary.ca

Vivek Kumar, MD contact

403-210-8650

vivek.kumar@ucalgary.ca

Canada1 site, 1 recruiting

  • University of Calgary, TRW building

    Calgary, Alberta, T2N 4Z6

    Asem Bala, MSc, asem.bala@ucalgary.ca

    Recruiting

Other trials in Canada

About this study

Official title: A Clinical Trial to Evaluate the Safety and Tolerability of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder

Obsessive-compulsive disorder (OCD) is a psychiatric condition marked by recurrent intrusive thoughts (obsessions) and ritualistic behaviors aimed at reducing distress (compulsions). While there exist a number of medications to treat this illness, half of those who need them either do not respond or can not tolerate current medications because of side effects. Therefore, there is an urgent need to develop new ways to treat this illness. One of the areas being explored as a potential option is based on what is now known as a strong link between the bacteria that live in our gut and the brain. Research has shown that a fecal transplant of the gut bacteria from healthy donors is able to improve health outcomes for people with depression and the investigators now want to expand this into OCD, given a known link between this condition and bacterial infection. To do this the investigators will use both the standard methods of bacterial identification via stool analysis, which looks at large bowel changes, and compare it to the Small Intestine Microbiome Aspiration (SIMBA) system, a small capsule that when swallowed allows a fluid sample to be collected from the participants' small intestine. This work will help the investigators assess the benefits of fecal transplant in OCD, and more importantly, identify how transplant changes the system, utilizing a novel technology to move the field forward.

Being tested
FMT Capsule + SIMBA Capsule
Keywords
OCD, Microbiome, FMT, Gut bacteria
Medical subject headings
Obsessive-Compulsive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FMT Capsule + SIMBA CapsuleCombination product

    Participants in this arm will receive FMT capsules in addition to their usual treatment. participants will also be administered SIMBA sample collection capsules.

Study groups in NCT05720793
Study groupRoleWhat they receive
FMT capsule + SIMBA CapsuleExperimentaladults with OCD who are being treated with an approved first line treatment for OCD medication will be assigned to receive FMT capsules as an adjunct treatment.
Receives: Combination Product: FMT Capsule + SIMBA Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Reported Adverse events

    Measured: 0-13 weeks

  2. Toronto Side Effects Scale (TSES)

    Changes in the Toronto Side Effects Scale (TSES). TSES a 32-item instrument used to evaluate the incidence, frequency, and severity of the central nervous system (CNS), gastrointestinal (GI), and sexual side effects.

    Measured: 0-13 weeks

Secondary outcomes (7)

  1. Global function/overall improvement (Quick Inventory of Depressive Symptomatology-Self-Report (QIDS))

    Quick Inventory of Depressive Symptomatology-Self-Report (QIDS). is a 16-item questionnaire that rates depression symptoms via self-assessment. Toral score is calculated but summing the scores of each of the 16 different questions. 0-5 Normal, 6-10 mild depression, 11-15 Moderate depression, 16-20 Severe depression and >21 is considered very severe depression.

    Measured: 0-13 weeks

  2. Global function/overall improvement (The General Anxiety Disorder-7 scale (GAD-7))

    The General Anxiety Disorder-7 scale (GAD-7). The 7-item tool is used to screen and assess for generalized anxiety. Score 0-4: Minimal Anxiety, Score 5-9: Mild Anxiety, Score 10-14: Moderate Anxiety and Score greater than 15: Severe Anxiety

    Measured: 0-13 weeks

  3. Global function/overall improvement (Positive and Negative Affect Schedule (PANAS))

    Positive and Negative Affect Schedule (PANAS). The PANAS is a self-report questionnaire that consists of two 10-item scales and measures both positive and negative emotions for participants. The total score is calculated by finding the sum of the 10 positive items, and then the 10 negative items. Scores range from 10 - 50 for both sets of items. higher score indicates more positive or negative affect respectively.

    Measured: 0-13 weeks

  4. Global function/overall improvement (Patient Health Questionnaire-9(PHQ9))

    Patient Health Questionnaire-9(PHQ9). The PHQ9 is used for screening and measuring the severity of depressive symptoms. The total score is the sum the numbers of all the checked responses under each heading. Cut off scores are: 0 - 4 None, 5 - 9 Mild, 10 - 14 Moderate, 15 - 19 Moderately Severe and 20 - 27 Severe.

    Measured: 0-13 weeks

  5. OCD symptoms (Y-BOCS)

    Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Total scores range from 0 to 40. 0-7 indicates subclinical symptoms, 8-15 mild symptoms, 16-23 moderate symptoms, 24-31 severe symptoms and 32-40 extreme symptoms

    Measured: 0-13 weeks

  6. OCD symptoms (TOCS)

    Toronto Obsessive-Compulsive Scale (TOCS). TOCS is a 21 item self-reported questionnaire that assesses several major symptom dimensions in OCD. A total score is calculated by adding each score of the 21 items, and dimension scores are calculated by averaging the sum of item scores within each dimension.

    Measured: 0-13 weeks

  7. Next generation fecal, Urine, Blood and saliva sequencing

    analysis of Fecal, urine, blood and saliva samples

    Measured: 0-13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2023
  2. Study start1 Jun 2023
  3. Primary completion1 Mar 2024 (estimated)
  4. Study completion30 Aug 2024 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05720793
Sponsor's protocol ID
NIM-FMT/OCD-2022
Acronym
FOCUSED
Status last verified
Nov 2023
First submitted
26 Jan 2023
Last updated
30 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We will also share our results via the "Gut Microbiota for Health Experts exchange", an online community where experts in this field share news, innovation and information on topics pertaining to the gut microbiota (www.gutmicrobiotaforhealth.com). This organization has over 10 000 online members and a large social media presence. Manuscripts will be published in scientific journals

Publications

  • Wlodarska M, Kostic AD, Xavier RJ. An integrative view of microbiome-host interactions in inflammatory bowel diseases. Cell Host Microbe. 2015 May 13;17(5):577-91. doi: 10.1016/j.chom.2015.04.008.

    PubMed 25974300

  • O'Hara AM, Shanahan F. The gut flora as a forgotten organ. EMBO Rep. 2006 Jul;7(7):688-93. doi: 10.1038/sj.embor.7400731.

    PubMed 16819463

  • Gorkiewicz G, Moschen A. Gut microbiome: a new player in gastrointestinal disease. Virchows Arch. 2018 Jan;472(1):159-172. doi: 10.1007/s00428-017-2277-x. Epub 2017 Dec 14.

    PubMed 29243124

  • Liu HN, Wu H, Chen YZ, Chen YJ, Shen XZ, Liu TT. Altered molecular signature of intestinal microbiota in irritable bowel syndrome patients compared with healthy controls: A systematic review and meta-analysis. Dig Liver Dis. 2017 Apr;49(4):331-337. doi: 10.1016/j.dld.2017.01.142. Epub 2017 Jan 21.

    PubMed 28179092

  • Zhong L, Shanahan ER, Raj A, Koloski NA, Fletcher L, Morrison M, Walker MM, Talley NJ, Holtmann G. Dyspepsia and the microbiome: time to focus on the small intestine. Gut. 2017 Jun;66(6):1168-1169. doi: 10.1136/gutjnl-2016-312574. Epub 2016 Aug 3. No abstract available.

    PubMed 27489239

  • Grace E, Shaw C, Whelan K, Andreyev HJ. Review article: small intestinal bacterial overgrowth--prevalence, clinical features, current and developing diagnostic tests, and treatment. Aliment Pharmacol Ther. 2013 Oct;38(7):674-88. doi: 10.1111/apt.12456. Epub 2013 Aug 20.

    PubMed 23957651

  • Ghoshal UC, Shukla R, Ghoshal U. Small Intestinal Bacterial Overgrowth and Irritable Bowel Syndrome: A Bridge between Functional Organic Dichotomy. Gut Liver. 2017 Mar 15;11(2):196-208. doi: 10.5009/gnl16126.

    PubMed 28274108

  • Luna RA, Foster JA. Gut brain axis: diet microbiota interactions and implications for modulation of anxiety and depression. Curr Opin Biotechnol. 2015 Apr;32:35-41. doi: 10.1016/j.copbio.2014.10.007. Epub 2014 Nov 21.

    PubMed 25448230

  • Camilleri M. Probiotics and irritable bowel syndrome: rationale, putative mechanisms, and evidence of clinical efficacy. J Clin Gastroenterol. 2006 Mar;40(3):264-9. doi: 10.1097/00004836-200603000-00020.

    PubMed 16633134

  • Desbonnet L, Garrett L, Clarke G, Bienenstock J, Dinan TG. The probiotic Bifidobacteria infantis: An assessment of potential antidepressant properties in the rat. J Psychiatr Res. 2008 Dec;43(2):164-74. doi: 10.1016/j.jpsychires.2008.03.009. Epub 2008 May 5.

    PubMed 18456279

  • Eutamene H, Bueno L. Role of probiotics in correcting abnormalities of colonic flora induced by stress. Gut. 2007 Nov;56(11):1495-7. doi: 10.1136/gut.2007.124040.

    PubMed 17938427

  • Gareau MG, Jury J, MacQueen G, Sherman PM, Perdue MH. Probiotic treatment of rat pups normalises corticosterone release and ameliorates colonic dysfunction induced by maternal separation. Gut. 2007 Nov;56(11):1522-8. doi: 10.1136/gut.2006.117176. Epub 2007 Mar 5.

    PubMed 17339238

  • Sullivan A, Nord CE. Probiotics and gastrointestinal diseases. J Intern Med. 2005 Jan;257(1):78-92. doi: 10.1111/j.1365-2796.2004.01410.x.

    PubMed 15606379

  • Girard SA, Bah TM, Kaloustian S, Lada-Moldovan L, Rondeau I, Tompkins TA, Godbout R, Rousseau G. Lactobacillus helveticus and Bifidobacterium longum taken in combination reduce the apoptosis propensity in the limbic system after myocardial infarction in a rat model. Br J Nutr. 2009 Nov;102(10):1420-5. doi: 10.1017/S0007114509990766. Epub 2009 Jun 29.

    PubMed 19563693

  • Logan AC, Katzman M. Major depressive disorder: probiotics may be an adjuvant therapy. Med Hypotheses. 2005;64(3):533-8. doi: 10.1016/j.mehy.2004.08.019.

    PubMed 15617861

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FMT Capsule + SIMBA Capsule in people with Obsessive-Compulsive Disorder, run by Valerie Taylor at 1 site in Canada.

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 3 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: status not confirmed, as of the sponsor's last update on 30 Nov 2023. 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 Canada. 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Asem Bala, Msc, CCRP (4032107282, asem.bala@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 0-13 weeks). The study lists 2 primary outcomes in all. 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 NCT05720793, which also lists 18 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 30 Nov 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in