A Clinical Trial of Fecal Microbiota Transplantation in a Population With Obsessive-compulsive Disorder
NCT ID: NCT05720793
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2023-06-01
2024-08-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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FMT capsule + SIMBA Capsule
adults 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.
FMT Capsule + SIMBA Capsule
Participants in this arm will receive FMT capsules in addition to their usual treatment. participants will also be administered SIMBA sample collection capsules.
Interventions
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FMT Capsule + SIMBA Capsule
Participants in this arm will receive FMT capsules in addition to their usual treatment. participants will also be administered SIMBA sample collection capsules.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Suicidality
* regular intake of antibiotics, prebiotics, or probiotics
* Clinically diagnosed with IBD, Crohn's disease, Ulcerative colitis, or Celiac disease
* Immune suppression
* intestinal obstruction
* Oropharyngeal dysphagia or other swallowing disorder
* \< 2 bowel movements per week
* Breastfeeding, pregnant or seeking to get pregnant during the course of this study
18 Years
65 Years
ALL
No
Sponsors
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Nimble Science Ltd.
INDUSTRY
University of Calgary
OTHER
Valerie Taylor
OTHER
Responsible Party
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Valerie Taylor
MD, Phd, FRCPC, Professor, Department Head
Principal Investigators
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Valere Taylor, MD,PhD,FRCPC
Role: PRINCIPAL_INVESTIGATOR
Professor, Head of Department
Locations
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University of Calgary, TRW building
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Asem Bala, MSc
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Rao AV, Bested AC, Beaulne TM, Katzman MA, Iorio C, Berardi JM, Logan AC. A randomized, double-blind, placebo-controlled pilot study of a probiotic in emotional symptoms of chronic fatigue syndrome. Gut Pathog. 2009 Mar 19;1(1):6. doi: 10.1186/1757-4749-1-6.
Messaoudi M, Lalonde R, Violle N, Javelot H, Desor D, Nejdi A, Bisson JF, Rougeot C, Pichelin M, Cazaubiel M, Cazaubiel JM. Assessment of psychotropic-like properties of a probiotic formulation (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175) in rats and human subjects. Br J Nutr. 2011 Mar;105(5):755-64. doi: 10.1017/S0007114510004319. Epub 2010 Oct 26.
Dickerson FB, Stallings C, Origoni A, Katsafanas E, Savage CL, Schweinfurth LA, Goga J, Khushalani S, Yolken RH. Effect of probiotic supplementation on schizophrenia symptoms and association with gastrointestinal functioning: a randomized, placebo-controlled trial. Prim Care Companion CNS Disord. 2014;16(1):PCC.13m01579. doi: 10.4088/PCC.13m01579. Epub 2014 Feb 13.
Other Identifiers
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NIM-FMT/OCD-2022
Identifier Type: -
Identifier Source: org_study_id