680 LYOPHILIZED ORALLY ADMINISTERED FECAL MICROBIOTA TRANSPLANTATION IN THE MANAGEMENT OF ULCERATIVE COLITIS (LOTUS STUDY) – RESULTS FROM THE INDUCTION PHASE OF A RANDOMIZED CONTROLLED TRIAL

2021 ◽  
Vol 160 (6) ◽  
pp. S-135
Author(s):  
Craig Haifer ◽  
Aiasha Saikal ◽  
Sudarshan Paramsothy ◽  
Thomas J. Borody ◽  
Dr Simon Ghaly ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Randomized Controlled Trial ◽  
Fecal Microbiota Transplantation ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Induction Phase ◽  
Randomized Controlled ◽  
Study Results

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 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 Efficacy of metformin and fermentable fiber combination therapy in adolescents with severe obesity and insulin resistance: study protocol for a double-blind randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Edward C. Deehan ◽  
Eloisa Colin-Ramirez ◽  
Lucila Triador ◽  
Karen L. Madsen ◽  
Carla M. Prado ◽  
...  
Keyword(s):  
Insulin Resistance ◽  
Randomized Controlled Trial ◽  
Combination Therapy ◽  
Gut Microbiome ◽  
Controlled Trial ◽  
Fecal Microbiota ◽  
Metabolic Effects ◽  
Microbiota Composition ◽  
Randomized Controlled ◽  
Secondary Outcomes

Abstract Background Accumulating evidence suggests that the metabolic effects of metformin and fermentable fibers are mediated, in part, through diverging or overlapping effects on the composition and metabolic functions of the gut microbiome. Pre-clinical animal models have established that the addition of fiber to metformin monotherapy improves glucose tolerance. However, possible synergistic effects of combination therapy (metformin plus fiber) have not been investigated in humans. Moreover, the underlying mechanisms of synergy have yet to be elucidated. The aim of this study is to compare in adolescents with obesity the metabolic effects of metformin and fermentable fibers in combination with those of metformin or fiber alone. We will also determine if therapeutic responses correlate with compositional and functional features of the gut microbiome. Methods This is a parallel three-armed, double-blinded, randomized controlled trial. Adolescents (aged 12–18 years) with obesity, insulin resistance (IR), and a family history of type 2 diabetes mellitus (T2DM) will receive either metformin (850 mg p.o. twice/day), fermentable fibers (35 g/day), or a combination of metformin plus fiber for 12 months. Participants will be seen at baseline, 3, 6, and 12 months, with a phone follow-up at 1 and 9 months. Primary and secondary outcomes will be assessed at baseline, 6, and 12 months. The primary outcome is change in IR estimated by homeostatic model assessment of IR; key secondary outcomes include changes in the Matsuda index, oral disposition index, body mass index z-score, and fat mass to fat-free mass ratio. To gain mechanistic insight, endpoints that reflect host-microbiota interactions will also be assessed: obesity-related immune, metabolic, and satiety markers; humoral metabolites; and fecal microbiota composition, short-chain fatty acids, and bile acids. Discussion This study will compare the potential metabolic benefits of fiber with those of metformin in adolescents with obesity, determine if metformin and fiber act synergistically to improve IR, and elucidate whether the metabolic benefits of metformin and fiber associate with changes in fecal microbiota composition and the output of health-related metabolites. This study will provide insight into the potential role of the gut microbiome as a target for enhancing the therapeutic efficacy of emerging treatments for T2DM prevention. Trial registration ClinicalTrials.gov NCT04578652. Registered on 8 October 2020.

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