Bipolar DepressionPhase 2/3NCT03279224
Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Bipolar Disorder
A Phase 2/3 study testing Allogenic FMT and Autologous FMT in people with Bipolar Depression, run by Valerie Taylor at 1 site in Canada.
Trial summary
Every human harbors complex microbial communities (collectively, the human 'microbiome') that cover the skin and the body's mucosal surfaces. There is mounting evidence of an interaction between the intestinal microbiota, the gut, and the central nervous system (CNS) in what is recognized as the microbiome-gut-brain… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Allogenic FMT and Autologous FMT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Phase 2/3
- 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
- Between 18-65 years of age
- Outpatient status
- Have a diagnosis of bipolar disorder (BD) (type I or II) according to the Mini International Neuropsychiatric Interview (MINI)
- Have been on a stable first line treatment for BD depression at an adequate dose for at least 8 weeks prior to study entry
- Suffer from a current depressive episode (Montgomery-Åsberg Depression Rating Scale (MADRS) score at screening and baseline of ≥ 12)
Who cannot join
- DSM-IV criteria for substance abuse within the last 6 months or lifetime dependency
- Active eating disorders
- Schizophrenia or schizoaffective disorder
- Current psychotic symptoms
- A Young Mania Rating Scale (YMRS) score of ≥12 at screening
- Active suicidality
Show all 13Show fewer
- Regular intake of non-steroidal anti-inflammatory drugs or iron supplements in the 3 months prior to study entry
- Use of prebiotics or probiotics for medical purposes, use of antibiotics or any experimental drug in the 3 months prior to study entry
- Chronic gastrointestinal diseases
- Conditions causing immunosuppression
- A significant bleeding disorder
- Any contraindication to colonoscopy
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of the Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Bipolar Disorder
Every human harbors complex microbial communities (collectively, the human 'microbiome') that cover the skin and the body's mucosal surfaces. There is mounting evidence of an interaction between the intestinal microbiota, the gut, and the central nervous system (CNS) in what is recognized as the microbiome-gut-brain axis. Based on this compelling body of evidence, there is growing enthusiasm for work that is focused on translating this emerging association into novel therapies for psychiatric illness.
Fecal microbiota transplantation(FMT) is a technique in which gut bacteria are transferred from a healthy screened donor to a patient, with the goal to introduce or restore a stable microbial community in the gut.There are no clinical trials examining the impact of FMT on Bipolar Disorder (BD). However, there is biological rationale to support this type of treatment, given the known inflammatory underpinnings of this illness.
Read more
The objective of this study is to assess the effectiveness of this very novel therapy targeting the gut-brain axis, FMT, to treat bipolar depression.
Study Hypotheses:
Main hypothesis: FMT from healthy donors to patients with BD depression will improve depression symptoms as an adjunct to approved medication.
Secondary hypotheses:
- FMT will also reduce anxiety and global function
- FMT is safe and will be well tolerated by the patients
- Improvements in clinical parameters will be associated with specific changes in the intestinal microbiome and/or metabolites in stool and serum
Read the detailed description
The primary goals of this proof of concept study are to determine the effectiveness, safety and tolerability of FMT in adults with BD depression.
Objective 1: To evaluate the effectiveness of the combination of a currently accepted approved therapy for BD depression + FMT in individuals with BD depression. This will be assessed through a change in the Montgomery-Ãsberg Depression Rating Scale (MADRS) total score from baseline (pre-intervention) to the final visit (week 24). The investigators will also assess the proportion of patients withdrawing from study due to inadequate control of depressive symptoms.
Secondary objective 2: To evaluate the effectiveness of FMT on anxiety symptoms and global function/overall improvement in participants with BD depression. Secondary objective 3: To determine the safety and tolerability of FMT in individuals with BD depression. Safety will be evaluated by solicited and unsolicited adverse events, including serious adverse events, throughout the study period. Tolerability will be assessed using the Toronto Side Effect Scale (TSES). This is a 32-item instrument that is designed to establish incidence, frequency, and severity of CNS, gastrointestinal, and sexual side effects.
Secondary objective 4: To assess the effect of FMT on microbiome profile (community structure and functional metagenome) and fecal metabolome. Changes in fecal microbiome profile and fecal metabolome from baseline to the final visit will be assessed using next generation sequencing and nuclear magnetic resonance (NMR) spectrometry, respectively. Changes in mood rating scales will be correlated with a specific microbiome and metabolome signature. Intestinal microbiome and metabolome of healthy donors will also be assessed.
- Conditions
- Bipolar Depression
- Being tested
- Allogenic FMT, Autologous FMT
- Keywords
- Bipolar, Depression, FMT, Microbiome
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogenic FMTBiological
Fifty (50) g of screened donor feces will be weighed and homogenized with 30 mL of sterile 0.9 N NaCl + 10% glycerol using a sterile 330 micron micro-filter-separated double-compartment polyethylene bag in the Stomacher® Paddle Blender.
2.The volume of fecal filtrate corresponding to fifty (50) g of donor stools will be transferred into a 50 mL Falcon tube with screw top and frozen at -80oC.
- For colonoscopy administration, three (3) Falcon tubes of thawed FMT concentrated will be diluted to a total volume of 300 mL with 0.9N NaCl and will be transported to the endoscopy suite. In the endoscopy suite, the FMT product will be packaged into 6 x 50 ml syringes for patient delivery by colonoscopy.
Autologous FMTBiological
- Fifty (50) g of the participant's feces will be weighed and homogenized with 30 mL of sterile 0.9 N NaCl + 10% glycerol using a sterile 330 micron micro-filter-separated double-compartment polyethylene bag in the Stomacher® Paddle Blender.
3.The volume of fecal filtrate corresponding to fifty (50) g of participant's stools will be transferred into a 50 mL Falcon tube with screw top and frozen at -80oC.
- For colonoscopy administration, three (3) Falcon tubes of thawed FMT concentrated will be diluted to a total volume of 300 mL with 0.9N NaCl and will be transported to the endoscopy suite. In the endoscopy suite, the FMT product will be packaged into 6 x 50 ml syringes for patient delivery by colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Allogenic FMT | Active comparator | Participants Randomized to this arm will receive FMT (Fecal Microbiota Transplantation) from a healthy, screened individual with no personal or family history of an Axis 1 disorder. Receives: Biological: Allogenic FMT |
| Autologous FMT | Placebo comparator | Participants Randomized to this arm will receive FMT (Fecal Microbiota Transplantation) by re-infusion of their own feces donated earlier in the study. Receives: Biological: Autologous FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the MADRS total score from baseline (pre-intervention) to the final visit (week 24).
The MADRS score will be used to assess the effectiveness of the combination of a currently accepted approved therapy plus FMT on depression symptoms. The MADRS score will also help assess the percentage of patients who show inadequate control of depressive symptoms
Measured: Every 2 weeks for 24 weeks
Secondary outcomes (5)
Changes in the the Clinical Global Impression (CGI) scale
The effectiveness of Approved treatment + FMT in controlling anxiety symptoms and global function/Overall improvement will be assessed through the CGI
Measured: Every 2 weeks for 24 weeks
Changes in the the World Health Organization Quality of life (WHOQOL-BREF) rating
The effectiveness of Approved treatment + FMT in improving the quality of life of bipolar depression patients will be assessed through the World Health Organization Quality of life (WHOQOL-BREF) questionnaire.
Measured: Every 2 weeks for 24 weeks
Side effects as reported on the Toronto Side Effect Scale (TSES)
The tolerability of FMT will be assessed using the Toronto Side effects Scale (TSES)
Measured: Every 2 weeks for 24 weeks
Changes in fecal microbiome profile
Stool samples will be collected and analysed using next generation sequencing to examine changes in Changes in fecal microbiome profile
Measured: stool sample collected at Baseline (Visit 2), week 12 and at week 24
Changes in fecal Metabolome
Stool samples will be collected and analysed using nuclear magnetic resonance (NMR) spectrometry
Measured: stool sample collected at Baseline (Visit 2), week 12 and at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jan 2018
- Primary completion15 Mar 2022
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (61)Papers the sponsor has linked to this study.
- Other trials for Bipolar DepressionStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adults with BD depression being treated with an approved medication will be assigned to either allogenic FMT (from a healthy, screened individual with no personal or family history of an Axis 1 disorder) or autologous FMT (re-infusion of own feces)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valerie Taylor
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor-investigator, Valerie Taylor, Women's College Hospital
- Investigators
- Valerie Taylor, MD, PhD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279224
- Sponsor's protocol ID
- STAN-FMT-WCH-2016
- Status last verified
- Apr 2022
- First submitted
- 5 Sep 2017
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: both the descriptive and analyzed data, including individual patient data, will be submitted to the National Database for Clinical Trials related to Mental Illness (NDCT), which is part of the National Institute of Mental Health Data Archive (NDA). The data are de-identified and will be made available to qualified researchers, who have to request access to the dataset.
Publications
Brietzke E, Stertz L, Fernandes BS, Kauer-Sant'anna M, Mascarenhas M, Escosteguy Vargas A, Chies JA, Kapczinski F. Comparison of cytokine levels in depressed, manic and euthymic patients with bipolar disorder. J Affect Disord. 2009 Aug;116(3):214-7. doi: 10.1016/j.jad.2008.12.001. Epub 2009 Feb 28.
PubMed 19251324Guloksuz S, Cetin EA, Cetin T, Deniz G, Oral ET, Nutt DJ. Cytokine levels in euthymic bipolar patients. J Affect Disord. 2010 Nov;126(3):458-62. doi: 10.1016/j.jad.2010.04.027.
PubMed 20537397Jiang H, Ling Z, Zhang Y, Mao H, Ma Z, Yin Y, Wang W, Tang W, Tan Z, Shi J, Li L, Ruan B. Altered fecal microbiota composition in patients with major depressive disorder. Brain Behav Immun. 2015 Aug;48:186-94. doi: 10.1016/j.bbi.2015.03.016. Epub 2015 Apr 13.
PubMed 25882912Naseribafrouei A, Hestad K, Avershina E, Sekelja M, Linlokken A, Wilson R, Rudi K. Correlation between the human fecal microbiota and depression. Neurogastroenterol Motil. 2014 Aug;26(8):1155-62. doi: 10.1111/nmo.12378. Epub 2014 Jun 1.
PubMed 24888394Neufeld KM, Kang N, Bienenstock J, Foster JA. Reduced anxiety-like behavior and central neurochemical change in germ-free mice. Neurogastroenterol Motil. 2011 Mar;23(3):255-64, e119. doi: 10.1111/j.1365-2982.2010.01620.x. Epub 2010 Nov 5.
PubMed 21054680Diaz Heijtz R, Wang S, Anuar F, Qian Y, Bjorkholm B, Samuelsson A, Hibberd ML, Forssberg H, Pettersson S. Normal gut microbiota modulates brain development and behavior. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3047-52. doi: 10.1073/pnas.1010529108. Epub 2011 Jan 31.
PubMed 21282636Fremont M, Coomans D, Massart S, De Meirleir K. High-throughput 16S rRNA gene sequencing reveals alterations of intestinal microbiota in myalgic encephalomyelitis/chronic fatigue syndrome patients. Anaerobe. 2013 Aug;22:50-6. doi: 10.1016/j.anaerobe.2013.06.002. Epub 2013 Jun 19.
PubMed 23791918Aroniadis OC, Brandt LJ. Fecal microbiota transplantation: past, present and future. Curr Opin Gastroenterol. 2013 Jan;29(1):79-84. doi: 10.1097/MOG.0b013e32835a4b3e.
PubMed 23041678Xu MQ, Cao HL, Wang WQ, Wang S, Cao XC, Yan F, Wang BM. Fecal microbiota transplantation broadening its application beyond intestinal disorders. World J Gastroenterol. 2015 Jan 7;21(1):102-11. doi: 10.3748/wjg.v21.i1.102.
PubMed 25574083Vrieze A, Van Nood E, Holleman F, Salojarvi J, Kootte RS, Bartelsman JF, Dallinga-Thie GM, Ackermans MT, Serlie MJ, Oozeer R, Derrien M, Druesne A, Van Hylckama Vlieg JE, Bloks VW, Groen AK, Heilig HG, Zoetendal EG, Stroes ES, de Vos WM, Hoekstra JB, Nieuwdorp M. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012 Oct;143(4):913-6.e7. doi: 10.1053/j.gastro.2012.06.031. Epub 2012 Jun 20.
PubMed 22728514Zoller V, Laguna AL, Prazeres Da Costa O, Buch T, Goke B, Storr M. [Fecal microbiota transfer (FMT) in a patient with refractory irritable bowel syndrome]. Dtsch Med Wochenschr. 2015 Aug;140(16):1232-6. doi: 10.1055/s-0041-103798. Epub 2015 Aug 11. German.
PubMed 26261935Colman RJ, Rubin DT. Fecal microbiota transplantation as therapy for inflammatory bowel disease: a systematic review and meta-analysis. J Crohns Colitis. 2014 Dec;8(12):1569-81. doi: 10.1016/j.crohns.2014.08.006. Epub 2014 Sep 13.
PubMed 25223604Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology. 2015 Jul;149(1):223-37. doi: 10.1053/j.gastro.2015.05.008. Epub 2015 May 15.
PubMed 25982290EISEMAN B, SILEN W, BASCOM GS, KAUVAR AJ. Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery. 1958 Nov;44(5):854-9. No abstract available.
PubMed 13592638Messaoudi 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.
PubMed 20974015
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of the Safety and Efficacy of Fecal Microbiota Transplantation in a Population With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT03279224
- Acronym / sponsor ID
- STAN-FMT-WCH-2016
- Conditions
- Bipolar Depression
- Keywords
- Bipolar, Depression, FMT, Microbiome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Valerie TaylorUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Sep 2017 (actual)
- 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.
Every human harbors complex microbial communities (collectively, the human 'microbiome') that cover the skin and the body's mucosal surfaces. There is mounting evidence of an interaction between the intestinal microbiota, the gut, and the central nervous system (CNS) in what is recognized as the microbiome-gut-brain axis. Based on this compelling body of evidence, there is growing enthusiasm for work that is focused on translating this emerging association into novel therapies for psychiatric illness.
Fecal microbiota transplantation(FMT) is a technique in which gut bacteria are transferred from a healthy screened donor to a patient, with the goal to introduce or restore a stable microbial community in the gut.There are no clinical trials examining the impact of FMT on Bipolar Disorder (BD). However, there is biological rationale to support this type of treatment, given the known inflammatory underpinnings of this illness.
The objective of this study is to assess the effectiveness of this very novel therapy targeting the gut-brain axis, FMT, to treat bipolar depression.
Study Hypotheses:
Main hypothesis: FMT from healthy donors to patients with BD depression will improve depression symptoms as an adjunct to approved medication.
Secondary hypotheses:
- FMT will also reduce anxiety and global function
- FMT is safe and will be well tolerated by the patients
- Improvements in clinical parameters will be associated with specific changes in the intestinal microbiome and/or metabolites in stool and serum
Detailed description
The primary goals of this proof of concept study are to determine the effectiveness, safety and tolerability of FMT in adults with BD depression.
Objective 1: To evaluate the effectiveness of the combination of a currently accepted approved therapy for BD depression + FMT in individuals with BD depression. This will be assessed through a change in the Montgomery-Ãsberg Depression Rating Scale (MADRS) total score from baseline (pre-intervention) to the final visit (week 24). The investigators will also assess the proportion of patients withdrawing from study due to inadequate control of depressive symptoms.
Secondary objective 2: To evaluate the effectiveness of FMT on anxiety symptoms and global function/overall improvement in participants with BD depression. Secondary objective 3: To determine the safety and tolerability of FMT in individuals with BD depression. Safety will be evaluated by solicited and unsolicited adverse events, including serious adverse events, throughout the study period. Tolerability will be assessed using the Toronto Side Effect Scale (TSES). This is a 32-item instrument that is designed to establish incidence, frequency, and severity of CNS, gastrointestinal, and sexual side effects.
Secondary objective 4: To assess the effect of FMT on microbiome profile (community structure and functional metagenome) and fecal metabolome. Changes in fecal microbiome profile and fecal metabolome from baseline to the final visit will be assessed using next generation sequencing and nuclear magnetic resonance (NMR) spectrometry, respectively. Changes in mood rating scales will be correlated with a specific microbiome and metabolome signature. Intestinal microbiome and metabolome of healthy donors will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Adults with BD depression being treated with an approved medication will be assigned to either allogenic FMT (from a healthy, screened individual with no personal or family history of an Axis 1 disorder) or autologous FMT (re-infusion of own feces)
| Arm | Type | Receives |
|---|---|---|
| Allogenic FMT | Active comparator | Biological: Allogenic FMTParticipants Randomized to this arm will receive FMT (Fecal Microbiota Transplantation) from a healthy, screened individual with no personal or family history of an Axis 1 disorder. |
| Autologous FMT | Placebo comparator | Biological: Autologous FMTParticipants Randomized to this arm will receive FMT (Fecal Microbiota Transplantation) by re-infusion of their own feces donated earlier in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Between 18-65 years of age
- Outpatient status
- Have a diagnosis of bipolar disorder (BD) (type I or II) according to the Mini International Neuropsychiatric Interview (MINI)
- Have been on a stable first line treatment for BD depression at an adequate dose for at least 8 weeks prior to study entry
- Suffer from a current depressive episode (Montgomery-Åsberg Depression Rating Scale (MADRS) score at screening and baseline of ≥ 12)
Key exclusion criteria (13 listed)
- DSM-IV criteria for substance abuse within the last 6 months or lifetime dependency
- Active eating disorders
- Schizophrenia or schizoaffective disorder
- Current psychotic symptoms
- A Young Mania Rating Scale (YMRS) score of ≥12 at screening
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 |
|---|---|---|
| Allogenic FMTFifty (50) g of screened donor feces will be weighed and homogenized with 30 mL of sterile 0.9 N NaCl + 10% glycerol using a sterile 330 micron micro-filter-separated double-compartment polyethylene bag in the Stomacher® Paddle Blender. 2.The volume of fecal filtrate corresponding to fifty (50) g of donor stools will be transferred into a 50 mL Falcon tube with screw top and frozen at -80oC. 3. For colonoscopy administration, three (3) Falcon tubes of thawed FMT concentrated will be diluted to a total volume of 300 mL with 0.9N NaCl and will be transported to the endoscopy suite. In the endoscopy suite, the FMT product will be packaged into 6 x 50 ml syringes for patient delivery by colonoscopy. | Biological | Allogenic FMT |
| Autologous FMT1. Fifty (50) g of the participant's feces will be weighed and homogenized with 30 mL of sterile 0.9 N NaCl + 10% glycerol using a sterile 330 micron micro-filter-separated double-compartment polyethylene bag in the Stomacher® Paddle Blender. 3.The volume of fecal filtrate corresponding to fifty (50) g of participant's stools will be transferred into a 50 mL Falcon tube with screw top and frozen at -80oC. 3. For colonoscopy administration, three (3) Falcon tubes of thawed FMT concentrated will be diluted to a total volume of 300 mL with 0.9N NaCl and will be transported to the endoscopy suite. In the endoscopy suite, the FMT product will be packaged into 6 x 50 ml syringes for patient delivery by colonoscopy. | Biological | Autologous FMT |
Primary outcome
Change in the MADRS total score from baseline (pre-intervention) to the final visit (week 24).
Time frame: Every 2 weeks for 24 weeks
The MADRS score will be used to assess the effectiveness of the combination of a currently accepted approved therapy plus FMT on depression symptoms. The MADRS score will also help assess the percentage of patients who show inadequate control of depressive symptoms
5 secondary outcomes
Changes in the the Clinical Global Impression (CGI) scale
Time frame: Every 2 weeks for 24 weeks
Changes in the the World Health Organization Quality of life (WHOQOL-BREF) rating
Time frame: Every 2 weeks for 24 weeks
Side effects as reported on the Toronto Side Effect Scale (TSES)
Time frame: Every 2 weeks for 24 weeks
Changes in fecal microbiome profile
Time frame: stool sample collected at Baseline (Visit 2), week 12 and at week 24
Changes in fecal Metabolome
Time frame: stool sample collected at Baseline (Visit 2), week 12 and at week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Background: PubMed 19251324Brietzke E, Stertz L, Fernandes BS, Kauer-Sant'anna M, Mascarenhas M, Escosteguy Vargas A, Chies JA, Kapczinski F. Comparison of cytokine levels in depressed, manic and euthymic patients with bipolar disorder. J Affect Disord. 2009 Aug;116(3):214-7. doi: 10.1016/j.jad.2008.12.001. Epub 2009 Feb 28.
- Background: PubMed 20537397Guloksuz S, Cetin EA, Cetin T, Deniz G, Oral ET, Nutt DJ. Cytokine levels in euthymic bipolar patients. J Affect Disord. 2010 Nov;126(3):458-62. doi: 10.1016/j.jad.2010.04.027.
- Background: PubMed 25882912Jiang H, Ling Z, Zhang Y, Mao H, Ma Z, Yin Y, Wang W, Tang W, Tan Z, Shi J, Li L, Ruan B. Altered fecal microbiota composition in patients with major depressive disorder. Brain Behav Immun. 2015 Aug;48:186-94. doi: 10.1016/j.bbi.2015.03.016. Epub 2015 Apr 13.
- Background: PubMed 24888394Naseribafrouei A, Hestad K, Avershina E, Sekelja M, Linlokken A, Wilson R, Rudi K. Correlation between the human fecal microbiota and depression. Neurogastroenterol Motil. 2014 Aug;26(8):1155-62. doi: 10.1111/nmo.12378. Epub 2014 Jun 1.
- Background: PubMed 21054680Neufeld KM, Kang N, Bienenstock J, Foster JA. Reduced anxiety-like behavior and central neurochemical change in germ-free mice. Neurogastroenterol Motil. 2011 Mar;23(3):255-64, e119. doi: 10.1111/j.1365-2982.2010.01620.x. Epub 2010 Nov 5.
- Background: PubMed 21282636Diaz Heijtz R, Wang S, Anuar F, Qian Y, Bjorkholm B, Samuelsson A, Hibberd ML, Forssberg H, Pettersson S. Normal gut microbiota modulates brain development and behavior. Proc Natl Acad Sci U S A. 2011 Feb 15;108(7):3047-52. doi: 10.1073/pnas.1010529108. Epub 2011 Jan 31.
- Background: PubMed 23791918Fremont M, Coomans D, Massart S, De Meirleir K. High-throughput 16S rRNA gene sequencing reveals alterations of intestinal microbiota in myalgic encephalomyelitis/chronic fatigue syndrome patients. Anaerobe. 2013 Aug;22:50-6. doi: 10.1016/j.anaerobe.2013.06.002. Epub 2013 Jun 19.
- Background: PubMed 23041678Aroniadis OC, Brandt LJ. Fecal microbiota transplantation: past, present and future. Curr Opin Gastroenterol. 2013 Jan;29(1):79-84. doi: 10.1097/MOG.0b013e32835a4b3e.
- Background: PubMed 25574083Xu MQ, Cao HL, Wang WQ, Wang S, Cao XC, Yan F, Wang BM. Fecal microbiota transplantation broadening its application beyond intestinal disorders. World J Gastroenterol. 2015 Jan 7;21(1):102-11. doi: 10.3748/wjg.v21.i1.102.
- Background: PubMed 22728514Vrieze A, Van Nood E, Holleman F, Salojarvi J, Kootte RS, Bartelsman JF, Dallinga-Thie GM, Ackermans MT, Serlie MJ, Oozeer R, Derrien M, Druesne A, Van Hylckama Vlieg JE, Bloks VW, Groen AK, Heilig HG, Zoetendal EG, Stroes ES, de Vos WM, Hoekstra JB, Nieuwdorp M. Transfer of intestinal microbiota from lean donors increases insulin sensitivity in individuals with metabolic syndrome. Gastroenterology. 2012 Oct;143(4):913-6.e7. doi: 10.1053/j.gastro.2012.06.031. Epub 2012 Jun 20.
- Background: PubMed 26261935Zoller V, Laguna AL, Prazeres Da Costa O, Buch T, Goke B, Storr M. [Fecal microbiota transfer (FMT) in a patient with refractory irritable bowel syndrome]. Dtsch Med Wochenschr. 2015 Aug;140(16):1232-6. doi: 10.1055/s-0041-103798. Epub 2015 Aug 11. German.
- Background: PubMed 25223604Colman RJ, Rubin DT. Fecal microbiota transplantation as therapy for inflammatory bowel disease: a systematic review and meta-analysis. J Crohns Colitis. 2014 Dec;8(12):1569-81. doi: 10.1016/j.crohns.2014.08.006. Epub 2014 Sep 13.
- Microbiota Therapeutics Outcomes Program (MTOP)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. both the descriptive and analyzed data, including individual patient data, will be submitted to the National Database for Clinical Trials related to Mental Illness (NDCT), which is part of the National Institute of Mental Health Data Archive (NDA). The data are de-identified and will be made available to qualified researchers, who have to request access to the dataset.
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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.
Valerie Taylor, MD, PhD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Allogenic FMT and Autologous FMT in people with Bipolar Depression, 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 5 inclusion and 13 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 4 May 2022. 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. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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 the MADRS total score from baseline (pre-intervention) to the final visit (week 24). (time frame: Every 2 weeks for 24 weeks). 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 NCT03279224, which also lists 61 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 4 May 2022.