Fecal microbiota transplantation is associated with improved aspects of mental health of patients with recurrent Clostridioides difficile infections

Koppenol, Eline; Terveer, Elisabeth M.; Vendrik, Karuna E.W.; Lingen, Emilie van; Verspaget, Hein W.; Keller, Josbert J.; Kuijper, Ed J.; Giltay, Erik J.

doi:10.1016/j.jadr.2022.100355

Cited by 5 publications

(6 citation statements)

References 45 publications

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“…However, given the low number of patients who had a recurrence on the SER-109 arm (n = 11), the benefit of SER-109, regardless of recurrence, will need to be confirmed in future studies of this investigational agent. Several interesting hypotheses arise from this novel observation, which may be related to the potential role of the microbiome in disorders related to the gut-brain axis . CDI is associated with a disrupted microbiome which has been associated with mood disorders, including anxiety and depression .…”

Section: Discussionmentioning

confidence: 98%

“…Several interesting hypotheses arise from this novel observation, which may be related to the potential role of the microbiome in disorders related to the gut-brain axis. 26 , 27 , 28 CDI is associated with a disrupted microbiome which has been associated with mood disorders, including anxiety and depression. 6 In the ECOSPOR III trial, engraftment of SER-109 dose species was associated with metabolic changes, critical to inhibition of C difficile spore germination.…”

Section: Discussionmentioning

confidence: 99%

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Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109

Garey

Gonzales-Luna

et al. 2023

JAMA Netw Open

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ImportanceRecurrent Clostridioides difficile infection (CDI) is a debilitating disease leading to poor health-related quality of life (HRQOL), loss of productivity, anxiety, and depression. The potential association of treatment with HRQOL has not been well evaluated.ObjectivesTo explore the association of SER-109 compared with placebo on HRQOL in patients with recurrent CDI up to week 8.Design, Setting, and ParticipantsThis study was a secondary analysis of a randomized, double-blind, placebo-controlled trial that took place at 56 sites in the US and Canada from July 2017 to April 2020 and included 182 patients randomized to SER-109 or placebo groups.InterventionsSER-109 or placebo (4 capsules once daily for 3 days) following antibiotics for CDI.Main Outcomes and MeasuresExploratory analysis of HRQOL using the disease specific Clostridioides difficile Quality of Life Survey (Cdiff32) assessed at baseline, week 1, and week 8.ResultsIn this study, 182 patients (109 [59.9%] female; mean age, 65.5 [16.5] years) were randomized to SER-109 (89 [48.9%]) or placebo (93 [51.1%]) groups and were included in the primary and exploratory analyses. Baseline Cdiff32 scores were similar between patients in the SER-109 and placebo groups (52.0 [18.3] vs 52.8 [18.7], respectively). The proportion of patients with overall improvement from baseline in the Cdiff32 total score was higher in the SER-109 arm than placebo at week 1 (49.4% vs 26.9%; P = .012) and week 8 (66.3% vs 48.4%; P = .001).Greater improvements in total and physical domain and subdomain scores were observed in patients in the SER-109 group compared with placebo as early as week 1, with continued improvements observed at week 8. Among patients in the placebo group, improvements in HRQOL were primarily observed in patients with nonrecurrent CDI while patients in the SER-109 group reported improvements in HRQOL, regardless of clinical outcome.Conclusions and RelevanceIn this secondary analysis of a phase 3 clinical trial, SER-109, an investigational microbiome therapeutic was associated with rapid and steady improvement in HRQOL compared with placebo through 8 weeks, an important patient-reported outcome.Trial RegistrationClinicalTrials.gov Identifier: NCT03183128

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109

Garey

Gonzales-Luna

et al. 2023

JAMA Netw Open

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“…Xie et al (2019) reported that the antidepressant effects of six rounds of FMT were still present at the 18-month follow-up. Koppenol et al (2022) reported that the antidepressant effects persisted until week 26 when the study ended.…”

Section: Faecal Microbiota Transplantmentioning

confidence: 99%

Section: Faecal Microbiota Transplantmentioning

confidence: 99%

“…Another human study involved performing FMTs on 49 patients with recurrent C. difficile infections (Koppenol et al, 2022). Following the FMTs from healthy donors, the patient's depression and anxiety scores showed significant improvement and the effects were maintained for up to 6 months (Koppenol et al, 2022). This study supports that FMTs could play a role in the treatment of both physical and psychiatric conditions, although it is important to note the limitations of this study, including the small scale of the study and the evaluation of depressive symptoms in medical populations, where the medical condition itself may contribute to or account for the depressive symptoms.…”

Section: Faecal Microbiota Transplantmentioning

confidence: 99%

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Just a gut feeling: Faecal microbiota transplant for treatment of depression – A mini-review

Chang,

Chang

2024

J Psychopharmacol

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Background: The microbiota–gut–brain axis (MGBA) allows bidirectional crosstalk between the brain and gut microbiota (GM) and is believed to contribute to regulating mood/cognition/behaviour/metabolism/health and homeostasis. Manipulation of GM through faecal microbiota transplant (FMT) is a new, exciting and promising treatment for major depressive disorder (MDD). Aims: This mini-review examines current research into GM and FMT as a therapy for depression. Methods: Original research articles published in Medline/Cochrane Library/PubMed/EMBASE/PsycINFO databases/National Institute of Health website Clinicaltrials.gov/controlled-trials.com were searched. Full articles included in reference lists were evaluated. We summarise current data on GM and depression and discuss communication through the MGBA and the interaction of antidepressants and GM through this. We review compositions of dysbiosis in depressed cohorts, focusing on future directions in the treatment of MDD. Results: Studies have demonstrated significant gut dysbiosis in depressed patients compared to healthy cohorts, with overgrowth of pro-inflammatory microbiota, reduction in anti-inflammatory species and reduced overall stability and taxonomic richness. FMT allows the introduction of healthy microbiota into the gastrointestinal tract, facilitating the restoration of eubiosis. Conclusion: The GM plays an integral role in human health and disease through its communication with the rest of the body via the MGBA. FMT may provide a means to transfer the healthy phenotype into the recipient and this concept in humans is attracting enormous attention as a prospective treatment for psychopathologies, such as MDD, in the future. It may be possible to manipulate the GM in a number of ways, but further research is needed to determine the exact likelihood and profiles involved in the development and amelioration of MDD in humans, as well as the long-term effects and potential risks of this procedure.

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End-to-end donor screening and manufacturing controls: complementary quality-based strategies to minimize patient risk for donor-derived microbiome therapeutics

Goldsmith,

Tomkovich,

Auniņš

et al. 2024

Gut Microbes

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Fecal microbiota transplantation is associated with improved aspects of mental health of patients with recurrent Clostridioides difficile infections

Cited by 5 publications

References 45 publications

Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109

Assessment of Quality of Life Among Patients With Recurrent Clostridioides difficile Infection Treated with Investigational Oral Microbiome Therapeutic SER-109

Just a gut feeling: Faecal microbiota transplant for treatment of depression – A mini-review

End-to-end donor screening and manufacturing controls: complementary quality-based strategies to minimize patient risk for donor-derived microbiome therapeutics

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