Ethical Considerations in Microbial Therapeutic Clinical Trials

Woodworth, Michael H.; Sitchenko, Kaitlin L.; Carpentieri, Cynthia; Wang, Tiffany; Kraft, Colleen S.

doi:10.1080/20502877.2017.1387386

Cited by 9 publications

(6 citation statements)

References 21 publications

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“…To our knowledge, only two studies assessing physicians’ perception of FMT have been performed [23, 24]. While its benefits have been highlighted by the recent surge in research, FMT and its applications remain topics of interest and debate, especially from methodological and ethical standpoints [25].…”

Section: Discussionmentioning

confidence: 99%

Medical students’ perception on fecal microbiota transplantation

et al. 2019

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Background Fecal microbiota transplantation (FMT) has become an emergent method in the therapy of several intestinal diseases, mainly in Clostridium difficile recurrence. The training of FMT in medical schools is at its beginning and in countries where FMT is only occasionally carried out, it is important to know the perception of medical students on FMT. Methods We undertook a survey of 3rd year medical students not exposed to official academic information on FMT in order to find out their knowledge, beliefs and attitude toward FMT. A number of 80 students were asked to fill a dedicated online questionnaire. Results 52 out of 80 third year medical students anonymously filled the questionnaire (65% response rate). 34% of respondents reported to have at least a medium level of knowledge regarding FMT. The top indication for FMT identified by 76.9% was C. difficile infection; however, 60% believed FMT to be a promising therapy for a high number of conditions and while almost all respondents (98.1%) would recommend it, 88.4% would explore other options first. Colonoscopy was considered the optimal method of delivery by 42.3%. Only 39% of participants believed that patients would accept FMT, however 71% considered that a more socially acceptable name for the procedure and anonymous donors would increase acceptance rate. The risk of transmitting a disease undetected by donor stool screening procedures to the recipient was the most worrying side effect considered by 75% of respondents. 54% believed that more research is required for FMT to enter clinical practice and 55.7% of respondents would enroll patients in controlled clinical trials. Conclusions Medical students not exposed to educational information on FMT seem to be somewhat well informed about this method and would recommend it to their patients. Students, however, need to know more on the indications of FMT.

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Section: Discussionmentioning

confidence: 99%

Medical students’ perception on fecal microbiota transplantation

et al. 2019

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“…Given the variability among donors and recipients the extended risk/benefit ratio for FMT is unlikely to be clear for some time. 113 At this point, there is enough data for ASPs to ethically support FMT for recurrent and refractory C. difficile infections. Once on the formulary, though, ASPs may also restrict the use of a therapy to specific indications.…”

Section: Discussionmentioning

confidence: 99%

“…The first is that stool is not a uniform product and clinical outcomes may depend on the donor. 41 While healthy stool contains fewer ARGs than patients who have received multiple courses of antibiotics, the number is not zero and a recent study documents transmission of ARGs from the donor to the FMT recipient. 42 While it is currently difficult to identify all MDROs in donor stool, guidelines do recommend screening for ESBL and CRE to reduce this risk to the FMT recipient.…”

Section: Is Fmt a Viable Tool For Asps To Reduce The Threat Of Mdros?mentioning

confidence: 99%

The Ethics of Fecal Microbiota Transplant as a Tool for Antimicrobial Stewardship Programs

Murray¹,

Herbst²

2019

J. Law. Med. Ethics

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Multidrug resistant organisms (MDROs) are a public health threat that have reduced the effectiveness of many available antibiotics. Antimicrobial stewardship programs (ASPs) have been tasked with reducing antibiotic use and therefore the emergence of MDROs. While fecal microbiota transplant (FMT) has been proposed as therapy to reduce patient colonization of MDROs, this will require additional evidence to support an expansion of the current clinical indication for FMT. This article discusses the evidence and ethics of the expanded utilization of FMT by ASPs for reasons other than severe recurrent or refractory Clostridioides (formerly Clostridium) difficile infection.

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“…Following the marketing of drugs, off-label use by clinicians may also be a factor to consider in terms of both regulatory and ethical concerns, ensuring the patient is constantly informed of the efficacy and limitations of the treatment they are receiving. It is critical to ensure that with informed consent patients are fully aware of the limited knowledge available on long-term effects of administering microbiome therapies [140]. Microbiome can express both tumour suppressor and promoter properties, therefore interventions causing dysbiosis must be investigated to identify how genes and lifestyle (e.g., diet) affect the natural biodiversity of microbiome.…”

Section: Regulatory Considerations and Ethical Implicationsmentioning

confidence: 99%

Microbial Therapy and Breast Cancer Management: Exploring Mechanisms, Clinical Efficacy, and Integration Within the One Health Approach

Filippou,

Themistocleous,

Marangos

et al. 2023

Preprint

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This comprehensive review elucidates the profound relationship between the human microbiome and breast cancer managrement. Recent findings highlight the significance of microbial alterations in tissues, such as the gut and the breast, and their role in influencing breast cancer risk, development, progression, and treatment outcomes. We delve into how the gut microbiome can modulate systemic inflammatory responses and estrogen levels, thereby impacting cancer initiation and therapeutic drug efficacy. Furthermore, we explore the unique microbial diversity within breast tissue, indicating potential imbalances brought about by cancer and highlighting specific microbes as promising therapeutic targets. Emphasizing a holistic One Health approach, this review underscores the importance of integrating insights from human, animal, and environmental health to gain a deeper understanding of the complex microbe-cancer interplay. As the field advances, strategic manipulation of the microbiome and its metabolites presents innovative prospects for enhancing cancer diagnostics and therapeutics. However, rigorous clinical trials remain essential to confirm the potential of microbiota-based interventions in breast cancer management.

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Ethical Considerations in Microbial Therapeutic Clinical Trials

Cited by 9 publications

References 21 publications

Medical students’ perception on fecal microbiota transplantation

Medical students’ perception on fecal microbiota transplantation

The Ethics of Fecal Microbiota Transplant as a Tool for Antimicrobial Stewardship Programs

Microbial Therapy and Breast Cancer Management: Exploring Mechanisms, Clinical Efficacy, and Integration Within the One Health Approach

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