scholarly journals The safety and efficacy of fecal microbiota transplantation in a population with bipolar disorder during depressive episodes: study protocol for a pilot randomized controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Noah C. A. Cooke ◽  
Asem Bala ◽  
Johane P. Allard ◽  
Susy Hota ◽  
Susan Poutanen ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Randomized Controlled Trial ◽  
Fecal Microbiota Transplantation ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
High Recurrence Rate ◽  
Randomized Controlled ◽  
Depressive Episodes ◽  
Pilot Randomized Controlled Trial

Abstract Background Bipolar disorder (BD) is a chronic, debilitating illness with significant medical morbidity, often secondary to current treatments, and a high recurrence rate. This burden of disease reflects limitations in the tolerability and efficacy of current treatments. There is a compelling body of evidence linking the gut microbiota to mental illness, and while microbial manipulation via probiotic use has been studied as a therapeutic in BD, targeted trials of fecal microbiota transplantation (FMT) have not been conducted in this population. Methods and design We describe a pilot randomized controlled trial of FMT in participants with BD depression to assess the feasibility, efficacy, safety, and tolerability of this intervention. Individuals between 18 and 65 years of age will be enrolled in the study if they meet diagnostic criteria for a major depressive episode of at least moderate severity in the context of a BD diagnosis and have not responded to treatment for BD. Participants will be randomized 1:1 to receive either screened and processed donor stool (allogenic FMT) or their own stool (autologous FMT) via colonoscopy and monitored for 24 weeks post intervention. Depressive and manic symptoms, treatment acceptability, and gastrointestinal and other side effects are assessed at baseline (prior to randomization) and weekly. Stool samples to assess microbiome composition are obtained at baseline and 3 and 6 months. Discussion Currently, FMT represents a novel therapeutic option for treating BD depression. This protocol allows for the assessment of the feasibility, efficacy, acceptability, and safety of an intervention aimed at changing the microbiome in those with BD. Results from this pilot study will guide the development of larger trials of FMT for BD depression and may give more insight into how the gut microbiome are altered in those with BD depression. Trial registration Clinical Trials Gov NCT03279224

scholarly journals Treating insomnia improves mood state, sleep, and functioning in bipolar disorder: A pilot randomized controlled trial.

2015 ◽  
Vol 83 (3) ◽  
pp. 564-577 ◽  
Author(s):  
Allison G. Harvey ◽  
Adriane M. Soehner ◽  
Kate A. Kaplan ◽  
Kerrie Hein ◽  
Jason Lee ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Randomized Controlled Trial ◽  
Mood State ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

scholarly journals Ten-Year Follow-Up of Patients Treated with Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection from a Randomized Controlled Trial and Review of the Literature

2021 ◽  
Vol 9 (3) ◽  
pp. 548
Author(s):  
R. E. Ooijevaar ◽  
E. van Nood ◽  
A. Goorhuis ◽  
E. M. Terveer ◽  
J. van Prehn ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Fecal Microbiota Transplantation ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Randomized Controlled ◽  
Clostridioides Difficile ◽  
Clostridioides Difficile Infection

Fecal microbiota transplantation (FMT) has become a well-established treatment for recurrent Clostridioides difficile infection (rCDI). While short-term outcomes and adverse events relating to FMT have been well documented, there still is a paucity of data with regard to long-term safety. In this report, we describe the long-term follow-up of the prospective cohort of the first randomized controlled trial of FMT for rCDI, and review the existing literature. A total of 34 patients were treated with FMT for rCDI. Seven patients were still alive after a follow-up of more than 10 years and three patients were lost to follow-up. None of the 34 patients had experienced a new-onset autoimmune, gastrointestinal, or malignant disorder during follow-up. We did not find any deterioration or amelioration of pre-existing medical conditions. Furthermore, no deaths directly attributable to FMT could be identified. These findings are in accordance with the data in available literature. In conclusion, no long-term adverse events or complications directly attributable to FMT were found in our prospective cohort. Review of the available literature does not point to long-term risks associated with FMT in this elderly population, provided that carefully screened fecal suspensions are being used. No firm conclusion on the long-term safety of FMT in younger patients could be drawn.

scholarly journals The Effect of Multiprobiotics on Memory and Attention in Fibromyalgia: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 18 (7) ◽  
pp. 3543
Author(s):  
Diana Cardona ◽  
Pablo Roman ◽  
Fernando Cañadas ◽  
Nuria Sánchez-Labraca
Keyword(s):  
Randomized Controlled Trial ◽  
Therapeutic Option ◽  
Controlled Trial ◽  
Attention Task ◽  
Memory And Attention ◽  
Randomized Controlled ◽  
Mental Slowness ◽  
Larger Sample ◽  
Pilot Randomized Controlled Trial

Fibromyalgia syndrome (FMS) is a chronic, generalized and diffuse pain disorder accompanied by cognitive deficits such as forgetfulness, concentration difficulties, loss of vocabulary and mental slowness, among others. In recent years, FMS has been associated with altered intestinal microbiota, suggesting that modulating gut microbiota (for example, through probiotics) could be an effective therapeutic treatment. Thus, the aim of the present study was to continue exploring the role of probiotics in cognitive processes in patients with FMS. A pilot randomized controlled trial was conducted in 31 patients diagnosed with FMS to compare the effects of a multispecies probiotic versus a placebo on cognitive variables (memory and attention) after eight weeks. Results showed that treatment with a multispecies probiotic produced an improvement in attention by reducing errors on an attention task, but it had no effect on memory. More specifically, a tendency to reduce errors of omission (Go trials) during the Go/No-Go Task was observed after treatment. These findings, along with our previous results in impulsivity, underline the relevance of using probiotics as a therapeutic option in FMS, although more research with a larger sample size is required.

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