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Finding healthy stool donors for fecal transplant may be a tough prospect.
That’s what Australian researchers have discovered in the course of the FOCUS trial, which aims to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis and in the induction of remission.
Dr. Sudarshan Paramsothy and his colleagues at the University of New South Wales, Sydney, and the University of Melbourne, reported findings from donor recruitment for the FOCUS (Faecal Microbiota Transplantation in Ulcerative Colitis) trial at the American Gastroenterological Association’s 2014 James W. Freston Conference in Chicago.
The FOCUS study began enrolling patients in November, and is continuing to enroll, said Dr. Paramsothy. He and his colleagues also are continuing to recruit fecal donors. The data presented in Chicago were on an initial recruitment effort.
Overall, after screening, only 10% of recruits were considered eligible donors.
The researchers recruited donors through letters, newspaper ads, and online solicitations. They were told that they would be reimbursed for their time and for the transportation of their stool donations to the study site.
After responding, recruits were told that they would be expected to make stool donations five times a week for a minimum of 6 weeks.
The researchers had 116 potential donors over a 7-month recruitment period. Forty-seven declined immediately because of the 5-day-a-week donation requirement.
Twenty-seven had other issues, including medical comorbidities (13), risk factors for variant Cruetzfeldt-Jakob disease (6), and recent antibiotic use (1), that disqualified them from the study.
Thirty-eight potentially healthy donors underwent stool and blood testing. Fifteen of those donors were found to have a variety of parasites or indications of active infection that excluded them from donation: 5 had Dientamoeba fragilis, 5 had Blastocystis hominis, 1 had B. hominis and D. fragilis, 1 had Giardia intestinalis and D. fragilis, and 1 had norovirus and Clostridium difficile toxin, and 2 had leukocytes or erythrocytes on stool microscopy. One donor had indeterminate hepatitis C serology.
While it is not uncommon for people to have asymptomatic parasite carriage in the gastrointestinal tract, “we did not expect it in such a high proportion,” said Dr. Paramsothy. “Our screened donor population was not an at-risk group,” he said, adding that they were otherwise healthy and had no risk factors or gastrointestinal symptoms.
“Our detection rates may have been slightly higher as donor stool samples were sent to a pathology center with expert, specialized GI parasitologists for review,” Dr. Paramsothy said.
There’s also some question as to whether some parasites, such as Blastocystis and Dientamoeba, “are truly pathogenic or rather commensal organisms,” he said, adding that it was thought better to exclude patients with these parasites if there were any doubt.
That left 22 potential donors. Further questioning found that two had used antibiotics in between recruitment and stool testing, and one was living with a household member who was positive for D. fragilis.
Of the 19 remaining, 1 dropped out and 18 were screened again. Three were excluded because of a body mass index over 30 kg/m2, 1 because of illicit drug use, 1 because of irregular bowel movements after starting a new medication, and 1 because of uncontrolled anxiety and depression. Dr. Paramsothy said that high-BMI donors were excluded because some studies have shown that gut microbiota potentially influence insulin sensitivity and obesity. Illicit drug use is a red flag because it is potentially associated with blood-borne disease acquisition, he said.
At the end, there were only 12 healthy donors, 10% of the starting 116. Dr. Paramsothy said that it was not necessary to have a single donor for every single patient in the trial. He said he could not disclose currently the number needed for the study, however.
The donor results “suggest that while FMT is an exciting new therapy, it is difficult to identify appropriate and willing anonymous donors,” Dr. Paramsothy said. But that should not have an overall impact on FMT as a therapy, he said – rather, it might just make it harder for a small practice to establish an in-house FMT program.
Dr. Paramsothy reported no relevant financial conflicts.
The AGA hosted the annual James W. Freston conference in Chicago this August, and this year’s topic was therapeutic innovations in microbiome research and technology, with a focus on fecal microbiota transplantation (FMT). There were more than 140 participants from 16 countries present to discuss evolving research and clinical approaches to FMT.
The 2-day meeting opened with lectures highlighting evolving knowledge about the human microbiome, and how quickly its composition can change with environmental exposures such as travel or diet. These were followed by additional presentations about FMT as a treatment for Clostridium difficile and inflammatory bowel disease, and intriguing work on the role of the gut microbiome in the metabolic syndrome. There were many productive discussions among the FMT enthusiasts, some of which are summarized in this issue of GI & Hepatology News. The final session of the meeting featured presentations about institutional review board regulation of trials involving FMT, and updates from the Food and Drug Administration.
It is clear that FMT is an effective treatment for recurrent C. diff., and may even be positioned as an earlier treatment option for some patients. The short-term safety of FMT in existing trials is reassuring, but there was general consensus at the meeting that we need further study of long-term outcomes of recipients. In the United States, the FDA has relaxed its stance on FMT for recurrent C. diff., but an investigational new drug application must be filed with the FDA for its use for any other purposes. Studies of FMT for inflammatory bowel diseases, irritable bowel syndrome, and other conditions are quite limited at this time, and it is clear that additional research is needed before we will understand the associations and potential causality related to the microbiome. In addition, there is a desperate need for further understanding of the complex ecology of the gut microbiome as well as what additional viruses, phages, and proteins may be transferred from a donor to recipient.
Patients have eagerly embraced FMT as a potential treatment for a variety of illnesses, but the evidence for safety and efficacy for any conditions beyond C. diff. is lacking. Therefore, many attendees at the conference emphasized the need for better education about the potential risks and the need for more study.
The Freston conference was a great success, and highlighted some of the important progress that has been made in understanding the human microbiome and its therapeutic potential, but also underscored the near-term research priorities and safety concerns.
Dr. David T. Rubin is Joseph B. Kirsner Professor of Medicine, section chief of gastroenterology, hepatology and nutrition, and codirector of the Digestive Diseases Center, University of Chicago.
The AGA hosted the annual James W. Freston conference in Chicago this August, and this year’s topic was therapeutic innovations in microbiome research and technology, with a focus on fecal microbiota transplantation (FMT). There were more than 140 participants from 16 countries present to discuss evolving research and clinical approaches to FMT.
The 2-day meeting opened with lectures highlighting evolving knowledge about the human microbiome, and how quickly its composition can change with environmental exposures such as travel or diet. These were followed by additional presentations about FMT as a treatment for Clostridium difficile and inflammatory bowel disease, and intriguing work on the role of the gut microbiome in the metabolic syndrome. There were many productive discussions among the FMT enthusiasts, some of which are summarized in this issue of GI & Hepatology News. The final session of the meeting featured presentations about institutional review board regulation of trials involving FMT, and updates from the Food and Drug Administration.
It is clear that FMT is an effective treatment for recurrent C. diff., and may even be positioned as an earlier treatment option for some patients. The short-term safety of FMT in existing trials is reassuring, but there was general consensus at the meeting that we need further study of long-term outcomes of recipients. In the United States, the FDA has relaxed its stance on FMT for recurrent C. diff., but an investigational new drug application must be filed with the FDA for its use for any other purposes. Studies of FMT for inflammatory bowel diseases, irritable bowel syndrome, and other conditions are quite limited at this time, and it is clear that additional research is needed before we will understand the associations and potential causality related to the microbiome. In addition, there is a desperate need for further understanding of the complex ecology of the gut microbiome as well as what additional viruses, phages, and proteins may be transferred from a donor to recipient.
Patients have eagerly embraced FMT as a potential treatment for a variety of illnesses, but the evidence for safety and efficacy for any conditions beyond C. diff. is lacking. Therefore, many attendees at the conference emphasized the need for better education about the potential risks and the need for more study.
The Freston conference was a great success, and highlighted some of the important progress that has been made in understanding the human microbiome and its therapeutic potential, but also underscored the near-term research priorities and safety concerns.
Dr. David T. Rubin is Joseph B. Kirsner Professor of Medicine, section chief of gastroenterology, hepatology and nutrition, and codirector of the Digestive Diseases Center, University of Chicago.
The AGA hosted the annual James W. Freston conference in Chicago this August, and this year’s topic was therapeutic innovations in microbiome research and technology, with a focus on fecal microbiota transplantation (FMT). There were more than 140 participants from 16 countries present to discuss evolving research and clinical approaches to FMT.
The 2-day meeting opened with lectures highlighting evolving knowledge about the human microbiome, and how quickly its composition can change with environmental exposures such as travel or diet. These were followed by additional presentations about FMT as a treatment for Clostridium difficile and inflammatory bowel disease, and intriguing work on the role of the gut microbiome in the metabolic syndrome. There were many productive discussions among the FMT enthusiasts, some of which are summarized in this issue of GI & Hepatology News. The final session of the meeting featured presentations about institutional review board regulation of trials involving FMT, and updates from the Food and Drug Administration.
It is clear that FMT is an effective treatment for recurrent C. diff., and may even be positioned as an earlier treatment option for some patients. The short-term safety of FMT in existing trials is reassuring, but there was general consensus at the meeting that we need further study of long-term outcomes of recipients. In the United States, the FDA has relaxed its stance on FMT for recurrent C. diff., but an investigational new drug application must be filed with the FDA for its use for any other purposes. Studies of FMT for inflammatory bowel diseases, irritable bowel syndrome, and other conditions are quite limited at this time, and it is clear that additional research is needed before we will understand the associations and potential causality related to the microbiome. In addition, there is a desperate need for further understanding of the complex ecology of the gut microbiome as well as what additional viruses, phages, and proteins may be transferred from a donor to recipient.
Patients have eagerly embraced FMT as a potential treatment for a variety of illnesses, but the evidence for safety and efficacy for any conditions beyond C. diff. is lacking. Therefore, many attendees at the conference emphasized the need for better education about the potential risks and the need for more study.
The Freston conference was a great success, and highlighted some of the important progress that has been made in understanding the human microbiome and its therapeutic potential, but also underscored the near-term research priorities and safety concerns.
Dr. David T. Rubin is Joseph B. Kirsner Professor of Medicine, section chief of gastroenterology, hepatology and nutrition, and codirector of the Digestive Diseases Center, University of Chicago.
Finding healthy stool donors for fecal transplant may be a tough prospect.
That’s what Australian researchers have discovered in the course of the FOCUS trial, which aims to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis and in the induction of remission.
Dr. Sudarshan Paramsothy and his colleagues at the University of New South Wales, Sydney, and the University of Melbourne, reported findings from donor recruitment for the FOCUS (Faecal Microbiota Transplantation in Ulcerative Colitis) trial at the American Gastroenterological Association’s 2014 James W. Freston Conference in Chicago.
The FOCUS study began enrolling patients in November, and is continuing to enroll, said Dr. Paramsothy. He and his colleagues also are continuing to recruit fecal donors. The data presented in Chicago were on an initial recruitment effort.
Overall, after screening, only 10% of recruits were considered eligible donors.
The researchers recruited donors through letters, newspaper ads, and online solicitations. They were told that they would be reimbursed for their time and for the transportation of their stool donations to the study site.
After responding, recruits were told that they would be expected to make stool donations five times a week for a minimum of 6 weeks.
The researchers had 116 potential donors over a 7-month recruitment period. Forty-seven declined immediately because of the 5-day-a-week donation requirement.
Twenty-seven had other issues, including medical comorbidities (13), risk factors for variant Cruetzfeldt-Jakob disease (6), and recent antibiotic use (1), that disqualified them from the study.
Thirty-eight potentially healthy donors underwent stool and blood testing. Fifteen of those donors were found to have a variety of parasites or indications of active infection that excluded them from donation: 5 had Dientamoeba fragilis, 5 had Blastocystis hominis, 1 had B. hominis and D. fragilis, 1 had Giardia intestinalis and D. fragilis, and 1 had norovirus and Clostridium difficile toxin, and 2 had leukocytes or erythrocytes on stool microscopy. One donor had indeterminate hepatitis C serology.
While it is not uncommon for people to have asymptomatic parasite carriage in the gastrointestinal tract, “we did not expect it in such a high proportion,” said Dr. Paramsothy. “Our screened donor population was not an at-risk group,” he said, adding that they were otherwise healthy and had no risk factors or gastrointestinal symptoms.
“Our detection rates may have been slightly higher as donor stool samples were sent to a pathology center with expert, specialized GI parasitologists for review,” Dr. Paramsothy said.
There’s also some question as to whether some parasites, such as Blastocystis and Dientamoeba, “are truly pathogenic or rather commensal organisms,” he said, adding that it was thought better to exclude patients with these parasites if there were any doubt.
That left 22 potential donors. Further questioning found that two had used antibiotics in between recruitment and stool testing, and one was living with a household member who was positive for D. fragilis.
Of the 19 remaining, 1 dropped out and 18 were screened again. Three were excluded because of a body mass index over 30 kg/m2, 1 because of illicit drug use, 1 because of irregular bowel movements after starting a new medication, and 1 because of uncontrolled anxiety and depression. Dr. Paramsothy said that high-BMI donors were excluded because some studies have shown that gut microbiota potentially influence insulin sensitivity and obesity. Illicit drug use is a red flag because it is potentially associated with blood-borne disease acquisition, he said.
At the end, there were only 12 healthy donors, 10% of the starting 116. Dr. Paramsothy said that it was not necessary to have a single donor for every single patient in the trial. He said he could not disclose currently the number needed for the study, however.
The donor results “suggest that while FMT is an exciting new therapy, it is difficult to identify appropriate and willing anonymous donors,” Dr. Paramsothy said. But that should not have an overall impact on FMT as a therapy, he said – rather, it might just make it harder for a small practice to establish an in-house FMT program.
Dr. Paramsothy reported no relevant financial conflicts.
Finding healthy stool donors for fecal transplant may be a tough prospect.
That’s what Australian researchers have discovered in the course of the FOCUS trial, which aims to determine whether fecal microbiota transplantation (FMT) is safe and efficacious in the treatment of chronic active ulcerative colitis and in the induction of remission.
Dr. Sudarshan Paramsothy and his colleagues at the University of New South Wales, Sydney, and the University of Melbourne, reported findings from donor recruitment for the FOCUS (Faecal Microbiota Transplantation in Ulcerative Colitis) trial at the American Gastroenterological Association’s 2014 James W. Freston Conference in Chicago.
The FOCUS study began enrolling patients in November, and is continuing to enroll, said Dr. Paramsothy. He and his colleagues also are continuing to recruit fecal donors. The data presented in Chicago were on an initial recruitment effort.
Overall, after screening, only 10% of recruits were considered eligible donors.
The researchers recruited donors through letters, newspaper ads, and online solicitations. They were told that they would be reimbursed for their time and for the transportation of their stool donations to the study site.
After responding, recruits were told that they would be expected to make stool donations five times a week for a minimum of 6 weeks.
The researchers had 116 potential donors over a 7-month recruitment period. Forty-seven declined immediately because of the 5-day-a-week donation requirement.
Twenty-seven had other issues, including medical comorbidities (13), risk factors for variant Cruetzfeldt-Jakob disease (6), and recent antibiotic use (1), that disqualified them from the study.
Thirty-eight potentially healthy donors underwent stool and blood testing. Fifteen of those donors were found to have a variety of parasites or indications of active infection that excluded them from donation: 5 had Dientamoeba fragilis, 5 had Blastocystis hominis, 1 had B. hominis and D. fragilis, 1 had Giardia intestinalis and D. fragilis, and 1 had norovirus and Clostridium difficile toxin, and 2 had leukocytes or erythrocytes on stool microscopy. One donor had indeterminate hepatitis C serology.
While it is not uncommon for people to have asymptomatic parasite carriage in the gastrointestinal tract, “we did not expect it in such a high proportion,” said Dr. Paramsothy. “Our screened donor population was not an at-risk group,” he said, adding that they were otherwise healthy and had no risk factors or gastrointestinal symptoms.
“Our detection rates may have been slightly higher as donor stool samples were sent to a pathology center with expert, specialized GI parasitologists for review,” Dr. Paramsothy said.
There’s also some question as to whether some parasites, such as Blastocystis and Dientamoeba, “are truly pathogenic or rather commensal organisms,” he said, adding that it was thought better to exclude patients with these parasites if there were any doubt.
That left 22 potential donors. Further questioning found that two had used antibiotics in between recruitment and stool testing, and one was living with a household member who was positive for D. fragilis.
Of the 19 remaining, 1 dropped out and 18 were screened again. Three were excluded because of a body mass index over 30 kg/m2, 1 because of illicit drug use, 1 because of irregular bowel movements after starting a new medication, and 1 because of uncontrolled anxiety and depression. Dr. Paramsothy said that high-BMI donors were excluded because some studies have shown that gut microbiota potentially influence insulin sensitivity and obesity. Illicit drug use is a red flag because it is potentially associated with blood-borne disease acquisition, he said.
At the end, there were only 12 healthy donors, 10% of the starting 116. Dr. Paramsothy said that it was not necessary to have a single donor for every single patient in the trial. He said he could not disclose currently the number needed for the study, however.
The donor results “suggest that while FMT is an exciting new therapy, it is difficult to identify appropriate and willing anonymous donors,” Dr. Paramsothy said. But that should not have an overall impact on FMT as a therapy, he said – rather, it might just make it harder for a small practice to establish an in-house FMT program.
Dr. Paramsothy reported no relevant financial conflicts.
FROM THE 2014 JAMES W. FRESTON CONFERENCE
Key clinical point: Finding fecal transplant donors is not as simple as once thought.
Major finding: Only 10% of people recruited to be donors for a fecal microbiota transplant study were healthy enough to be eligible.
Data source: Donors recruited for the FOCUS study.
Disclosures: The study is sponsored by the University of New South Wales, Sydney. The investigators reported no relevant financial conflicts.
