Clinical Research Cases

In the group of patients who received donor feces infusion through the duodenum, a significant number (69-81%) had their symptoms resolved with the primary procedure alone, which was a significantly higher rate than the group that received vancomycin alone (approximately 27-31%). This study is considered a representative clinical trial that played an important role in establishing the basis for FMT in the treatment of recurrent C. difficile infections.

Remission was observed in the FMT treatment group at a significantly higher rate than the placebo group. However, it has also been reported that in chronic inflammatory bowel diseases such as ulcerative colitis, there may be significant differences in results depending on the donor.

The FMT transplant group achieved clinical remission at a significantly higher rate than the placebo group, and a tendency for intestinal microbial diversity to also recover was observed.

At 8 weeks of treatment, the FMT group achieved clinical remission at a higher rate than the control group. This study showed that a short-term intensive transplant can produce meaningful effects.

Researchers say that there may be differences in response rates depending on donor selection and administered dose. IBS is an area known to have particularly large differences in response depending on the donor.

At 3 months, the rate of symptom improvement in the FMT group was significantly higher than that in the placebo group. Since then, other studies have had mixed results depending on the donor, and the IBS area still requires additional research, including donor selection criteria.

A tendency for longer-lasting remission was observed in the group of patients who received FMT than in the control group. This study explored whether FMT could play an auxiliary role in managing intestinal inflammatory markers.

A trend toward improved cognitive function indices and lower readmission rates was observed in the group of patients who received FMT. This study showed that donor selection criteria can have a significant impact on outcomes.

At short-term and 6-month follow-up, the FMT group showed lower alcohol craving indices than the control group. This is an early-stage study exploring the possibility of application to mental health and addiction areas through the gut-brain axis mechanism.

After treatment, digestive symptoms were significantly reduced, and behavioral assessment scores also tended to improve. However, due to the limitation of being an open study (no control group), a follow-up long-term follow-up study was conducted.

Improvements in digestive symptoms remained stable even after two years, and behavioral evaluation indicators also tended to be maintained and improved. However, this is also a follow-up study without a control group, so it is too early to view it as conclusive evidence.

At 6 weeks after transplantation, the insulin sensitivity of the FMT group was significantly improved compared to the control group. However, this is an early-stage study focused on improving metabolic indicators, not a guaranteed result of weight loss itself.

A significant portion of the FMT group showed improvement in bowel frequency without medication. However, as the causes of constipation are diverse, it is difficult to say that it has the same effect on all constipation patients.

A trend towards improvement in intestinal permeability indices was observed after transplantation. The results do not directly guarantee improvements in liver function, and this is early research showing a link between barrier function and metabolic disease.

Complete or partial responses were observed in many of the patients treated. However, since the study was conducted on a small number of patients, and the patient population is very immunocompromised, infection risk management is an especially important area.

Along with improvement in constipation symptoms, some improvement trends were also reported in exercise-related indicators of Parkinson's disease. As this is still an early-stage study, it is too early to broadly interpret the effect as a treatment for Parkinson's disease itself.

After treatment, intestinal inflammation was controlled and patients were able to continue chemotherapy. This is an initial report with a small number of cases, and this is an area that requires further large-scale research.

In some patients, changes in gut microbiota composition were identified along with the tumor response. Around the same time, an independent research team by Davar et al. published similar results (see section below), and together the two studies constitute early evidence in this field. This is still a small, early-stage study and has not been established as a standard treatment.

Clinical benefit was identified in 6 of 15 anti-PD-1 resistant melanoma patients. In patients who responded, immunological changes such as increased CD8 T cell activity were also observed. The fact that two independent research teams reached similar conclusions at a similar time adds credence to research in this area, but it is still a small, early stage study.

The procedure was performed safely in the immunocompromised patients who participated in the study, and the effect of suppressing resistant bacteria was observed in many of them. As this study involves immunocompromised patients, this area requires particularly rigorous donor verification and monitoring.

As a result of genome analysis, it was confirmed that both cases originated from the same donor. This case later led the FDA to strengthen safety measures to include screening for multidrug-resistant bacteria in donor screening. The reason why our hospital strictly conducts donor testing through a specialized stool bank is also related to this background.

In the patient group that received autologous transplantation, the rate of decline in insulin secretion function (remaining beta cell function) was significantly slower than that in the control group. However, this is not a result of curing diabetes, but is an initial study aimed at slowing the progression.

We found that there were differences in the amount of improvement between patients, and that these differences were related to the microbial composition before the procedure. This study showed that the same effect does not appear in all patients, suggesting the importance of donor-recipient compatibility.

A significant proportion of the high-dose transplant group maintained symptom improvement at 3 years. However, this study is a follow-up study targeting participants in the initial randomized controlled trial by El-Salhy et al. introduced earlier, and it is difficult to apply the same method to all procedures due to the nature of the IBS area, where results can vary greatly depending on the donor.

Improvement in symptoms was observed in many participating patients, and no serious side effects were reported during the follow-up period. As this is a study targeting pediatric patients, the number of participants is not large, so it is appropriate to understand it as preliminary evidence for safety.

Although bloating-related symptoms were improved in some of the transplant group, it was not effective in all patients, as the paper title clearly states “in some patients,” and follow-up research is needed to determine factors that differentiate responders from non-responders.

A trend toward improvement in gastrointestinal symptom scores was observed in the transplant group. As this is a pilot study with a small number of participants, confirmation is required through subsequent large-scale studies.

Enteritis was resolved in many patients, and cases of worsening of existing inflammatory bowel disease were relatively rare. However, in some patients, worsening of the underlying disease was also reported, showing that careful judgment based on individual conditions is necessary in this patient group.

This study is often cited as evidence supporting the mechanism of action of FMT (reconstruction of the intestinal ecosystem), as it was confirmed that the composition of the patient's intestinal microflora after transplantation became similar to that of the donor. As this is a single patient case, generalization is limited.

Improvements in liver enzyme levels (ALP) were observed in some patients. As this is an early preliminary study with a small number of participants, it is too early to consider it as evidence for general expectations of liver function improvement, and follow-up studies with a control group are needed.

Even in the immunocompromised patient group, enteritis was resolved at a relatively high rate, and no serious side effects related to the procedure were identified. This study showed that FMT can be considered even for immunocompromised patients after careful verification procedures.

It is not a procedure aimed at treating hair loss, but a finding accidentally observed during enteritis treatment, and since it is only a two-case report, it cannot be generalized as a hair loss treatment effect. It has been cited in several subsequent review papers as an example that led to the exploration of the gut-skin axis connection.

Improvements in the Skin Symptom Severity Index (PASI) were reported. As a single patient case, there is insufficient evidence to judge the general effectiveness of FMT for psoriasis, and controlled studies are needed.

A decrease in recurrence of urinary tract infection has been reported after FMT for the treatment of enteritis. As a single patient case, it is difficult to generalize as evidence for the purpose of treating urinary tract infection.

It was reported that weight changes were observed along with improvement in digestive symptoms. Eating disorders are diseases in which psychological factors are key, and FMT cannot be generalized as a treatment for eating disorders based on a single case.

Improvements in tic symptom assessment scores were reported along with digestive symptoms. As this was a single pediatric case, it cannot be broadly interpreted as a general treatment effect for tic disorders.

Improvements in depressive symptom assessment scores were reported. This is a single case, and the area of ​​mental health is at an early stage where the impact of the placebo effect can be particularly significant, requiring confirmation with controlled studies.

Improvement of skin rash and itching has been reported. As a single patient case, it is difficult to generalize about the effectiveness of treatment for chronic urticaria in general.

A decrease in the disease activity index (SLEDAI-2K) was observed in some patients. Phase 1 trials are mainly aimed at confirming safety, and due to the small number of participants, it is too early to draw definitive conclusions about effectiveness.

Some changes in neurological symptoms have been reported along with improvement in constipation symptoms. As it is a single case, there is no basis for interpreting it as a treatment effect for multiple sclerosis itself.

Improvements in platelet counts have been reported. This is a single patient case, and as blood diseases are a high-risk area, it is premature to interpret these results as general treatment options.

Changes in muscle strength-related symptoms have been reported along with improvements in digestive symptoms. As a single case, it is not a basis for judging the general effectiveness of treatment for myasthenia gravis.

This data is only released in the form of conference abstracts, not as full papers that have undergone formal peer review, so the level of evidence is lower than that of other items. This information is provided for reference only.

Frozen stored feces showed a similar level of therapeutic effect as fresh feces, supporting the possibility of storing and distributing frozen preparations through fecal banks. This provides the basis for operating a safe and standardized donation system.

The FMT group showed a higher treatment response than the fidaxomicin group. This study showed that FMT may be a better option than continuing to use only antibiotics for patients with repeated recurrences.

Most enteritis resolved, but in some patients, the course varied, with the underlying inflammatory bowel disease reacting or worsening. This shows that individual evaluation is necessary in patient groups with underlying diseases.

Safety and the possibility of some effectiveness have been evaluated, but there has not yet been much research in this area, so evidence is limited.

This study, along with the Paramsothy and Moayyedi studies introduced earlier, is often cited as representative evidence showing that FMT response in ulcerative colitis can vary greatly depending on the donor.

The safety and feasibility of the procedure were confirmed, and clinical responses were observed in some patients. This is an early-stage study without a control group.

Loss of e-antigen was reported in some patients and attracted attention as an interesting result, but it has not been established as a standard treatment as it was an early-stage study with a small number of participants.

A relatively more pronounced likelihood of response has been reported in lean patients with fatty liver disease. This study suggests that the causes of fatty liver may vary depending on body type.

Potential improvements in short-term survival and clinical parameters have been reported. As a small pilot study, larger-scale validation is needed to establish it as a standard of care.

It has been reported to reduce systemic inflammation and possibly improve cognitive function. As this is a recent study that has just been published, follow-up verification and replication studies need to be observed.

A decrease in proteinuria and changes in immune cells were reported, and no serious adverse reactions were observed. As this is an exploratory phase study, it is too early to standardly apply FMT to kidney disease.

A reduction in proteinuria has been reported, but this does not provide generalizable evidence from a single patient case.

As this is an early-stage study in which safety was first confirmed, it is too early to view it as an established treatment for dry eye syndrome.

Changes in both intestinal and joint symptoms have been reported. As a single case, it cannot be interpreted as a treatment effect for ankylosing spondylitis in general.

A reduction in the frequency of urinary tract infections was also reported, but the study was not designed to treat urinary tract infections and the evidence was at the level of an observational study.

Symptom relief and restoration of gut microbial diversity have been reported. This is a pilot study with a very small number of people, and strict safety management must be implemented as the patient population is immunocompromised.

It was evaluated in terms of intestinal microflora recovery after transplantation and the potential to prevent complications. This is a study with a relatively high level of evidence that explored the possibility of using FMT for preventive purposes.

This is a single patient case and is not a basis for judging the effectiveness of general treatment for multiple sclerosis.

This is a frequently cited case along with the two case reports by Rebello et al. (2017) introduced earlier. Again, this is a single patient case and cannot be interpreted as a general hair loss treatment effect.

FMT has been attempted as an adjunctive treatment to restore intestinal microflora. As a single case, it is not a basis for treating pneumonia per se.

Changes in COVID-19-related symptoms were reported after FMT, but the researchers themselves stated that they could not rule out the possibility that this was a coincidence. This is a single case and is not evidence for establishing a causal relationship.

Potential improvement in insulin sensitivity has been reported with combination therapy. The results do not guarantee weight loss per se, but the study focuses on improving metabolic indicators.

The researchers themselves stated that the long-term effects are still unclear, so careful interpretation is needed regarding the long-term safety and effectiveness in children and adolescents.

Tolerability and changes in intestinal microflora were confirmed. As this is an early-stage study without a control group, it is too early to determine the effectiveness of eating disorder treatment.

Improvements in barrier function have been reported. As this was a case study with a small number of patients, it is difficult to generalize to eating disorder treatments.

Primary clinical remission was reported in 72.9%, of whom 25 were followed for more than 5 years. There is relatively high level of evidence regarding the long-term safety of FMT in children.

Continuous changes in intestinal microflora were confirmed. This study mainly dealt with changes in microbial composition, and separate confirmation of improvement in clinical symptoms is required.

Potential improvements in bowel movement frequency and constipation symptoms have been reported. This is an initial preliminary study related to the 2016 randomized controlled trial by Tian et al. introduced earlier.

Safety was confirmed and the potential for improvement in some clinical parameters was assessed. This is a follow-up clinical trial designed more rigorously than the pilot study introduced earlier by Xue et al.

Changes in intestinal microflora and clinical indicators were observed over a long period of time. This is a follow-up follow-up study that expanded the initial randomized controlled trial by Bajaj et al. introduced earlier.

Survival rates, incidence of infections, and clinical indicators were compared. As this is a study targeting patients with high severity, careful patient selection is required for actual application.

Hives, abdominal pain, and changes in allergic symptoms have also been reported. This is a single case and cannot be interpreted as a general treatment effect.

Depressive symptom scores decreased in both patients, with improvement maintained during follow-up in one patient. Because this is a case report of only two people, the effect cannot be generalized.

The feasibility, acceptability, and safety of the treatment were evaluated first. This is a small pilot study and does not confirm the effectiveness of depression treatment.

It was reported that after FMT, gastrointestinal symptoms and autism-related assessment scores improved, and gut microbiota composition also changed. It is limited by being an open study without a control group.

Autism-related symptoms, gastrointestinal symptoms and changes in gut microbiota were compared. This is a meaningful study in that it directly compared the effectiveness of FMT with placebo in autism spectrum disorder.

Changes in symptoms have been reported, but must be interpreted considering the study design and follow-up period.

Better colonization of specific microbes from donors in the patient's gut was strongly associated with improved insulin sensitivity. Pre-treatment microbial diversity, dietary fiber intake, and inflammatory status also influenced colonization.

Favorable changes in insulin resistance-related markers have been reported. The researchers concluded that follow-up studies are needed to determine long-term effects.

Hepatic fat mass, glucose metabolism, insulin resistance, and microbial colonization were assessed. This is a small study with 20 participants, so there are limitations in confirming clinical effectiveness.

A high 3-month survival rate was observed in the FMT group, but caution is needed in interpretation due to the limitation that it was not a randomized study.

Short-term survival, hepatic encephalopathy, ascites, and changes in disease severity after FMT were evaluated and positive clinical outcomes were reported. As this is an open trial without a control group, follow-up verification is required.

Safety was confirmed, and changes in cognitive function and intestinal microflora were reported. This study showed the safety of the capsule route along with the enema method test by Bajaj et al. introduced earlier.

A more favorable trend regarding maintenance of remission was observed in patients with successful colonization of donor microorganisms. As this is a small pilot study, statistical confirmation is limited. (This is a microbial analysis paper from the same study as the 2020 Gut clinical trial by Sokol et al. introduced earlier.)

Four of nine patients experienced clinical benefit. In some patients, gut microbial diversity and donor microbial colonization were increased.

It was reported that diarrhea and depressive symptoms were alleviated after FMT. It has not been confirmed as a standard treatment for COVID-19 itself, and is an initial study aimed at managing accompanying symptoms.

It was reported that sleep disturbance indices improved after FMT. Because the study size and follow-up period are limited, follow-up large-scale studies are needed.

FMT was performed safely, and improvements in lesion severity and symptoms were reported. Changes in the composition and function of intestinal microorganisms were also confirmed.

Decreased skin severity has been reported, and treatment usage has also decreased in some patients. An association has been observed between colonization of specific donor microorganisms and clinical response.

Improvements in clinical symptoms and eosinophil levels were reported after combined treatment with FMT and prednisone. A limitation is that the effects of FMT alone cannot be separated.

A decrease in the severity of tic symptoms has been reported after FMT. The small sample size requires large-scale controlled studies.

Significant relief of tic symptoms was described after FMT. Results observed in a single patient cannot be generalized.

By analyzing small-scale human data and animal experiments, we suggested an association between reduced tic severity and changes in gut microbiota and serotonin pathways. It should be noted that the mechanism has not been confirmed in humans, and some animal test results are included.

In 5 out of 6 patients, motor/non-motor symptoms and constipation evaluation scores improved 4 weeks after the procedure. Some changes were observed up to 24 weeks, but this was a small study without a control group.

In this study, there was no statistically significant difference in motor symptoms between the FMT group and the placebo group. Rather, the incidence of transient gastrointestinal adverse reactions and adverse reactions in the FMT group was reported to be higher than that of the placebo group. This is an independent clinical trial that is different from the GUT-PARFECT study by Bruggeman et al. introduced earlier, showing that even for the same disease, conflicting results can be obtained depending on the study.

In the group where fresh fecal microorganisms were transplanted through colonoscopy, motor and non-motor symptoms, defecation, and quality of life were improved, and the effects were observed for at least 12 weeks.

It has been reported that combined treatment with FMT and laxatives may be more helpful in improving defecation and constipation symptoms than laxative treatment alone.

The safety and effectiveness of the procedure were evaluated, and improvements in bowel movement frequency and constipation symptoms were reported.

Clinical improvement and remission have been reported in some patients.

Clinical and endoscopic outcomes and colonization of donor microorganisms were assessed.

It has been reported that clinical and endoscopic remission was maintained in some patients.

Oral capsule FMT did not demonstrate significantly superior symptom improvement over placebo in this study. This example shows that FMT is not always effective in the area of ​​IBS.

Although the composition of intestinal microorganisms changed after FMT, symptom improvement was greater in the placebo group. This study showed that changes in intestinal microorganisms do not immediately mean symptom improvement.

Although some symptom changes were observed, no lasting or consistent clinical effects were established.

The study was terminated early because colonoscopic FMT resulted in a higher rate of infection clearance than vancomycin.

Diarrhea resolved in many patients, and in some patients who did not respond after the first dose, their infection resolved after re-administration.

High infection resolution rates and good follow-up outcomes were reported.

Although all three formulations were confirmed to have therapeutic potential, differences in first treatment response were observed depending on the formulation.

In this study, single enema FMT was not superior to vancomycin taper treatment. It shows that the route and frequency of administration can affect the results.

The group that received feces from healthy donors had a higher rate of recovery without recurrence of infection than the placebo group that received their own feces.

A high primary treatment success rate and long-term suppression of infection recurrence after colonoscopic FMT have been reported.

High survival and treatment success outcomes have been reported in plans combining repeat FMT with selective vancomycin treatment.

Results related to improved survival were reported in the early FMT group. Because this was not a randomized study, causality cannot be determined.

A high treatment success rate was reported, and differences in results depending on the route of administration and the patient's underlying disease were also analyzed.

The high treatment success rate and long-term safety of FMT have been reported even in elderly patients.

Improvements in joint symptoms, disease activity, and inflammation-related parameters have been reported after FMT. Generalization cannot be made from a single case.