Quality of life among older patients receiving faecal microbiota transplant for Clostridioides difficile infection

Clostridioides (formerly Clostridium) difficile infection (CDI) is a serious health threat, affecting approximately 40 people per 100 000 population per year with an estimated mortality rate of around 28% for patients older than 60 years (Rubak et al, 2023). CDI is under close surveillance by the European Centre for Disease Prevention and Control (ECDC) due to the global burden of healthcare-associated CDIs (ECDC, 2023). CDI occurs most frequently among patients over the age of 65 years receiving antibiotic treatment with predisposing factors such as comorbidity, immunosuppressive treatment and/or poor health status (Bouza et al, 2016). Symptoms include diarrhoea, abdominal pain and/or dehydration (Czepiel et al, 2019). Initial treatment for CDI consists of antibiotic therapy, but if the patient has a second or third recurrence, the possibility of non-pharmacological treatment arises through faecal microbiota transplantation (FMT) (Baunwall et al, 2020).

FMT is an evolving therapy for CDI, where patients receive faecal matter from an anonymous donor with a healthy intestinal flora, via colonoscopy, nasal tube, or capsules (Baunwall et al, 2020). Findings from a systematic review and meta-analysis by Baunwall et al (2020) indicated that FMT is an effective treatment for CDI, where 84% of the patients experienced clinical effect in physical symptoms 8 weeks after a single FMT treatment, while 91% of the patients undergoing a repeated FMT treatment experienced similar effects. The effectiveness of this treatment is further cemented through a recent randomised controlled trial that found FMT to be a highly effective treatment for first and second-time CDI indicating superiority to existing pharmaceutical treatments (Baunwall et al, 2022). Despite multiple studies concluding effective clinical results from FMT treatment, only a few studies have focused on patients' quality of life after undergoing this form of treatment.

Quality of life assessment in patients treated with FMT could help clinicians and researchers understand the overall impact of FMT and identify patients who would benefit from additional support to address the impact of FMT on their wellbeing. Some studies found that quality of life in patients with CDI was affected through decreased mobility and difficulty of maintaining personal hygiene (Wilcox et al, 2017; Heinrich et al, 2018). A randomised controlled trial by Kao et al (2017) examined the patient perspective and found that patients experienced significant improvement physically and psychologically 4 weeks after treatment, when compared with their pre-treatment physical and psychological wellbeing. In their systematic review, Guilfoyle et al (2021) concluded that knowledge of the patient experience of receiving FMT was insufficient and further studies are required to fully understand the quality of life from a patient perspective. This emphasises the need for more information about patients' perception of their quality of life while undergoing FMT treatment.

Aim

The aim of this study was to gain new knowledge about patients' experiences with regard to their quality of life during an FMT treatment course for CDI.

Methods

Participant recruitment

Patients older than 65 years, receiving FMT at an outpatient clinic were recruited in this study. All patients were included during the period for recruitment from 1 March 2022 to 1 May 2022. Older patients were chosen as the study population because older patients have increased risk for CDI and hence have an increased need for treatment compared with younger patients (Balsells et al, 2019).

Study design

All patients were interviewed at an outpatient clinic using semi-structured interviews 1 week after having undergone at least one FMT treatment. The interviews took place in private rooms at the outpatient clinic for a duration of 30-45 minutes and were recorded on a mobile device. A semi-structured interview guide was developed, taking inspiration from the World Health Organization Quality of Life (WHOQOL) tool domains (World Health Organization, 2012) (Table 1). This guide was pilot tested through an interview and minor adjustments were made. Seeing as these minor adjustments were mostly related to the formulation of the questions and not the content, the authors included the pilot interview in the analysis at the same level as the remaining five interviews that were conducted using the revised interview guide.

Analysis

Each interview was transcribed verbatim by the authors. The chosen analysis strategy consisted of the principles of systematic text condensation (Malterud, 2012). This method of analysis consists of four individual steps that lead to the formation of codes and was based on an inductive strategy with the purpose of identifying patterns and explanations to the given phenomenon (Thomas, 2006).

Ethical considerations

The study adheres to the ethical principles for medical research outlined in the Helsinki Declaration by ensuring that interviews were conducted ethically and respecting the autonomy and wellbeing of interviewees (World Medical Association, 2000). Prior to participation, patients signed a declaration of consent and permission to conduct the study was obtained before commencing the interviews. According to Danish law, the study did not require approval from the Ethics Committee due to the qualitative nature.

Results

A total of six patients aged 69–91 years were interviewed for the study. The study participants were predominantly female (n=4) and had one or multiple comorbidities (Table 2).

Five main themes relating to quality of life were identified through systematic text condensation of the conducted interviews. They were: decreased mental wellbeing; comfort through support and patient involvement from health professionals; no reservations about treatment; physical symptoms deter-mining level of activity; social isolation. Each of the five categories were thoroughly reviewed and sustained by quotes from the interviews.

Decreased mental wellbeing

Before receiving FMT, several patients' mental states were characterised in terms of worries, anxiety, and depressive symptoms, which indicates that their psychological wellbeing was negatively affected by the disease. This is illustrated through the quotation below:

‘This disease has given me anxiety. It affects me very strongly. It has ruined my life so far. I should have had so many good years left.

Patient 4

The negative psychological impact pretreatment was further elaborated by patient 4, who reported her mental state had led to suicidal thoughts and affected her quality of life in a negative way. In the same context, patient 5 described her mental state as being ‘in a hole’ due to her depressive thoughts:

‘One's quality of life is destroyed. It's tough, to put it bluntly. … Because I've had suicidal thoughts.’

Patient 4

‘I fell right into a hole, so it was absolutely terrifying.’

Patient 5

Through the interviews, it became clear that not all the interviewed patients had benefited from the FMT treatment and this impacted their psychological wellbeing. Some patients, including patient 5, felt the effect of treatment to be either transient or non-existent. This gave rise to feelings of injustice and frustration at the treatment's limited or lack of impact:

‘I had been told that maybe 9 out of 10 who got the first treatment got well and I couldn't see any difference. And why did I have to be number 10? Then I got one more treatment and it was the same again. … I cried and I thought it was unfair.’

Patient 5

Patients with a transient effect experienced a brief but clear change in their psychological wellbeing, resulting in a temporary feeling of joy and a restored quality of life. For patients 1 and 4, the treatment had an effect for about a week, where the positive impact was noticeable:

‘Well, it was only two days after I was down in the clinic, I could already feel a change. It helped for a week and then it started again.’

Patient 1

‘The week when I felt good, my quality of life came back to me.’

Patient 4

In contrast to this, another patient emphasised not feeling mentally ‘down’ during the illness, but rather just kept ‘rolling on’, while another patient expressed not being psychologically affected by FMT, but felt more limited by her physical symptoms. Before receiving the treatment, the mental state of the majority of patients was negatively affected during the course of the disease. For patients with a limited clinical effect after treatment, it led to a reduced quality of life, which for some patients resulted in anxiety-like symptoms. These symptoms ceased to exist in patients with temporary or permanent treatment effect, indicating a correlation between post-treatment clinical effect and patients' mental state.

Comfort through support and patient involvement from health professionals

All patients reported positive experiences with health professionals and in the treatment process. Most patients felt safe due to the professionalism and accessibility of health professionals. Patient 2 described how the health professionals' availability and ability to create reassurance during the start of treatment was a great support at a time of being very ill:

‘I was so well informed and at ease. [The doctor] was nice to come by with the chief physician to get everything sorted at the time. I was feeling unwell and it helped me to move on. When you're actually doing nothing but going to the toilet, it was really good to have that support.’

Patient 2

Four patients reported being well informed about the treatment and expectations for the follow-up process, including possible side effects. One patient spoke positively of the health professionals' availability and mentioned that she had always been able to call them if she had questions or needed additional information. Some patients had little effect from the treatment and mentioned the importance of health professionals having confidence in the form of treatment:

‘I think things are calmer now. I can feel that they [the health professionals] believe in it, I believe in it too. At some point it will probably work out.’

Patient 1

There was a difference among the patients regarding the need for information. Two patients acquired knowledge about the treatment from other sources and demonstrated very specific knowledge. In contrast, another patient had trouble relating to the given information and said it could be difficult to capture all of it. Another patient stated that he didn't need information about the treatment, but was more interested in the effect:

‘I didn't need to know more about what it is made of and how it works on the body. I don't care about that.’

Patient 3

Although all the patients felt safe and informed, patients reported having different and individual needs for involvement. Therefore, health professionals could benefit from examining and uncovering the need for involvement at the beginning of the process, so the patient's wishes and needs are met along the way.

No reservations about treatment

Most patients had no thoughts or concerns about the content of the treatment, or reservations about receiving faeces from an anonymous donor. Some said that they did not worry because they were informed that the contents were screened for various diseases and came from healthy donors. Two patients focused more on whether there would be a noticeable effect. Some patients appreciated the contents being encapsulated and not released until further down the digestive system, which indicates an ambivalence between the patients' thoughts about the contents and the form of administration:

‘Well, I just wanted it [faeces] to be encapsulated. Then I don't mind. I was just told that I had to have another person's faecal matter. And that they had put “socks” on it.’

Patient 3

‘The first time I thought, it's not exciting that you have to have faeces from someone else, but I got an explanation that it was dried etc, I don't remember how much I was told there was in every portion, but it's nice that someone wants to deliver such things.’

Patient 5

Two of the patients referred to the treatment as being a natural product as opposed to pharmacological treatment. Considering that all patients had acquired CDI secondary to antibiotic treatment, this shows that the patients felt reassured that they were being treated with a natural product:

‘I feel very comfortable with this treatment, because there are good results and it's kind of natural to get it in this way. It is often the case with medicine, you don't really know how it works on you, but this treatment, you get it directly. It's just worked so fast, it's been so good.’

Patient 2

Most patients expressed that their comorbidities were already being treated with other medical preparations overall limiting the concerns about the treatment.

Physical symptoms determining level of activity

All the patients reported being affected by the physical symptoms of the infectious state during the course of the disease, including two patients who stated that diarrhoea and increased fatigue prevented them from carrying out everyday activities:

‘When I was feeling the worst, I couldn't do anything … I had diarrhoea 10-15 times a day, so I was only able to stay at home.”

Patient 1

‘I was very unwell. I lost 10 kg. … I had to go to the toilet often and had a stomach ache. I felt really bad. My whole day was restless because I got up a little and had something to eat, and then in bed again. It was my everyday life.’

Patient 2

Some of the patients still felt limited in their everyday life after receiving the treatment, as they continued experiencing diarrhoea and reduced energy levels. Two patients reported that they refrained from physical activities due to a lack of energy or the fear of accidents, which was why they preferred being near a toilet when going out:

‘You have to be careful where you go. I've been out where I once had an accident.’

Patient 1

‘I stayed at home to protect my stomach. Everything I eat passes right through me.’

Patient 4

All the patients with effect from the treatment experienced an improvement in their physical state after the treatment. This indicates that when the treatment works, the patients' ability to resume their physical activity level increases. The majority of patients said that the ability to resume normal everyday physical and leisure activities, was due to fewer toilet visits and higher energy levels:

‘I have more energy. I have started training again. I get to do things at home that I haven't really been able to do.’

Patient 1

Although few of the patients were unable to resume their usual level of physical activity, it suggests that most patients experienced improvement after treatment due to increased energy levels and less diarrhoea than during the disease course. This finding indicates a correlation between the patients' perceived physical condition and the patients' ability to perform habitual activities of daily living, as fewer symptoms lead to a greater ability to resume normal physical activities.

Social isolation

All patients were limited in their social life before receiving treatment. Many had to avoid or cancel social events and isolate themselves because they were afraid of ‘accidents’. Patients who relapsed or did not recover continued to feel the need for social isolation, which negatively affected their psychological wellbeing.

Two patients reported that the isolation led to anxiety, depressive thoughts, and loneliness as they were not able to go to social events. Furthermore, the patients' previous experiences may have an impact on their current social life.

‘I think it is very hard, that you don't get visits from anyone because you constantly have to cancel and say “no, thanks” to invitations.’

Patient 2

Patients with partial or full recovery from the treatment were able to resume social activities in terms of leisure activities and social arrangements with friends and family. Three patients mentioned how they have slowly started to get out more and have visitors. A clear picture emerges of patients with treatment effect being able to resume their social life, while patients with failed treatment effect continue to isolate and avoid social activities.

Discussion

The purpose of this study was to examine and explore quality of life among older patients receiving FMT treatment for CDI. The findings of this study were supported by similar findings in other studies examining patient perspectives of FMT treatment for CDI regarding social, physical and psychological implications in patients including difficulties in activity participation, avoidance and cancellation of social events and overall dissatisfaction of current living situation (Pakyz et al, 2016; Zellmer et al, 2016; Kao et al, 2017). However, these studies found that almost all patients experienced increased quality of life in their physical, psychological, and social domains after receiving FMT treatment, due to the fact that the majority of patients were able to resume their daily social and physical activities and furthermore experienced increased mental wellbeing (Pakyz et al, 2016; Zellmer et al, 2016; Kao et al, 2017).

The patients did not show concerns about the content of the treatment and had no reservations about discussing the treatment with relatives. The content was stated by some as being a natural alternative to pharmacological treatment, which was an opinion shared by 41% of the patients in another study (Kao et al, 2017). However, not all patients share this opinion as 30% of the patients from Kao et al's (2017) study found the form of treatment ‘disgusting’. Those findings suggest an ambivalence in attitude to the content among FMT patients, consistent with the findings of this study. Some patients preferred that the contents were encapsulated, while other patients were solely concerned with treatment results. As the patients expressed their preference for the content being encapsulated and the fact that all patients were only treated with capsules as administration form, it was not possible to uncover whether the patients would have had the same attitude about other forms of administration.

Limitations

This study is limited to examining perceptions in patients treated with capsules, and perceptions may differ in patients treated with FMT through colonoscopy or intestinal tube.

Due to the qualitative nature of the study design, this study has strengths and limitations in relation to its credibility, transferability, dependability, and confirmability (Lincoln and Guba, 1985). One limitation is the presence of relatives at three of the interviews. This could impact the study's dependability and confirmability, because presence of the relatives may have influenced the patients' statements about their perceptions of quality of life. Due to the fragile and sensitive nature of this topic in terms of mental, social and physical wellbeing, there is a risk that the informants could be withholding relevant information relating to their perception about anxious or depressive thoughts as a result of having a relative present at the interview, which could affect the credibility of the findings. However, triangulation was used to strengthen the credibility by reviewing the analysed material with an experienced researcher to validate the findings and the conduct of qualitative analysis strategy.

The supportive findings from other FMT-related studies suggest that the patients' perceptions of quality of life in relation to FMT treatment are transferable across other countries with healthcare systems comparable to Denmark, such as the USA, Canada, and Australia. However, a cautious view should be taken on the transferability to other age groups, since this study only included patients over 65 years. Furthermore, there are often different psychosocial conditions found among elderly patients compared with younger patients, limiting the transferability of the findings across age groups. Elderly people experience a mental ageing process, where the self-perception, initiative, and ability to cope weakens in many, while a social aging process can cause loss of status and narrowing social circle (Clegg et al, 2013). This was prominent among the study participants, where one patient reported a lack of social life and initiative before the diagnosis of the disease. These factors could be an underlying cause of psychosocial problems affecting the patients' quality of life before being diagnosed with CDI.

Most of the informants suffered from comorbidity, which could have negatively impacted their quality of life, particularly patients who experienced a limited treatment effect. Comorbidity can significantly decrease the quality of life of patients with multiple chronic diseases, especially in psychological and physical domains (Makovski et al, 2019). Although the participants were homogenous in terms of age and treatment, there is nevertheless heterogeneity among the sample. By not taking socioeconomic status and gender into account when recruiting participants, this contributed to a greater variation, strengthening the transferability of the findings to a wider group of patients.

Conclusion

FMT had a significant impact on the patients' perceived quality of life. The disease negatively affected their mental wellbeing, especially when there was no treatment effect, leading to worry, anxiety, and depressive thoughts. Most patients were unconcerned about the content of faecal matter in the FMT capsules, but there was ambivalence between the content and the form of administration. Patients had positive experiences with health professionals and their support. Furthermore, health professionals should focus on patients who do not respond to the treatment. The study highlights the importance of considering patients' psychological, social, and physical wellbeing when evaluating FMT's impact on quality of life for patients with CDI.

KEY POINTS

• This study highlights the importance of considering quality of life as a factor when using faecal microbiota transplantation (FMT) to treat patients with Clostridioides difficile infection (CDI)
• Most of the interviewed patients reported an increase in overall quality of life after undergoing FMT treatment in terms of their physical, psychological and social wellbeing
• Patients with a transient or failed treatment effect reported stagnant or decreased quality of life due to CDI-related symptoms
• The findings highlight the importance of health professionals identifying patients with transient or absent treatment effect and their individual ways of handling the disease and everyday life to increase their quality of life

CPD reflective questions

• What would you suggest are the implications of the findings of this article in terms of practical and clinical care of patients who have undergone faecal microbiota transplantation treatment?
• How would you suggest caring for a patient with a transient or failed effect from this treatment?
• What would patients in your area of work think about receiving this treatment?