Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial.
<h4>Background</h4>Faecal microbiota transplantation (FMT) is recommended treatment for recurrent Clostridioides difficile infection and is studied as a potential modifier of other gastrointestinal and systemic disorders. Autologous FMT limits the potential risks of donor transplant mate...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Public Library of Science (PLoS)
2023-01-01
|
| Series: | PLoS ONE |
| Online Access: | https://doi.org/10.1371/journal.pone.0292132 |
| _version_ | 1797650669274923008 |
|---|---|
| author | Måns Stefansson Oscar Bladh Ola Flink Otto Skolling Hans-Peter Ekre Lars Rombo Lars Engstrand Johan Ursing |
| author_facet | Måns Stefansson Oscar Bladh Ola Flink Otto Skolling Hans-Peter Ekre Lars Rombo Lars Engstrand Johan Ursing |
| author_sort | Måns Stefansson |
| collection | DOAJ |
| description | <h4>Background</h4>Faecal microbiota transplantation (FMT) is recommended treatment for recurrent Clostridioides difficile infection and is studied as a potential modifier of other gastrointestinal and systemic disorders. Autologous FMT limits the potential risks of donor transplant material and enables prophylactic treatment. Capsulized FMT is convenient and accessible, but safety data are lacking.<h4>Aims</h4>To describe safety and tolerability of capsules containing autologous FMT, compared to placebo, in healthy volunteers treated with antibiotics.<h4>Method</h4>Healthy volunteers without antibiotic exposure during the past three months, that had a negative Clostridioides difficile stool sample, were recruited. Study persons donated faeces for production of capsules containing autologous microbiota. They were then given Clindamycin for seven days to disrupt the intestinal microbiota, which was followed by a two-day washout. Study persons were then randomized (1:1) to unsupervised treatment with autologous faecal matter or placebo, with two capsules twice daily for five days. A standardized questionnaire about side effects and tolerability, daily until day 28, and on days 60 and 180, was completed.<h4>Results</h4>Twenty-four study persons were included, all completed the treatment. One person from the placebo and FMT groups each, were lost to follow up from days 21 and 60, respectively. No study person experienced serious side effects, but severe fatigue was reported during the antibiotic period (n = 2). Reported side effects were mild to moderate and there were no significant differences between the groups. Reported general and intestinal health improved significantly and similarly in both groups after the antibiotic treatment. Time to normalized intestinal habits were 17 and 19 days from study start in the placebo group and the FMT group, respectively (p = 0.8).<h4>Conclusion</h4>Capsulized frozen autologous faecal microbiota transplantation was safe and well tolerated but did not affect time to normalized intestinal habits compared to placebo.<h4>Trial registration</h4>EudraCT 2017-002418-30. |
| first_indexed | 2024-03-11T16:04:39Z |
| format | Article |
| id | doaj.art-01e432be64434a46badc4142e7959063 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-03-11T16:04:39Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-01e432be64434a46badc4142e79590632023-10-25T05:31:08ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01189e029213210.1371/journal.pone.0292132Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial.Måns StefanssonOscar BladhOla FlinkOtto SkollingHans-Peter EkreLars RomboLars EngstrandJohan Ursing<h4>Background</h4>Faecal microbiota transplantation (FMT) is recommended treatment for recurrent Clostridioides difficile infection and is studied as a potential modifier of other gastrointestinal and systemic disorders. Autologous FMT limits the potential risks of donor transplant material and enables prophylactic treatment. Capsulized FMT is convenient and accessible, but safety data are lacking.<h4>Aims</h4>To describe safety and tolerability of capsules containing autologous FMT, compared to placebo, in healthy volunteers treated with antibiotics.<h4>Method</h4>Healthy volunteers without antibiotic exposure during the past three months, that had a negative Clostridioides difficile stool sample, were recruited. Study persons donated faeces for production of capsules containing autologous microbiota. They were then given Clindamycin for seven days to disrupt the intestinal microbiota, which was followed by a two-day washout. Study persons were then randomized (1:1) to unsupervised treatment with autologous faecal matter or placebo, with two capsules twice daily for five days. A standardized questionnaire about side effects and tolerability, daily until day 28, and on days 60 and 180, was completed.<h4>Results</h4>Twenty-four study persons were included, all completed the treatment. One person from the placebo and FMT groups each, were lost to follow up from days 21 and 60, respectively. No study person experienced serious side effects, but severe fatigue was reported during the antibiotic period (n = 2). Reported side effects were mild to moderate and there were no significant differences between the groups. Reported general and intestinal health improved significantly and similarly in both groups after the antibiotic treatment. Time to normalized intestinal habits were 17 and 19 days from study start in the placebo group and the FMT group, respectively (p = 0.8).<h4>Conclusion</h4>Capsulized frozen autologous faecal microbiota transplantation was safe and well tolerated but did not affect time to normalized intestinal habits compared to placebo.<h4>Trial registration</h4>EudraCT 2017-002418-30.https://doi.org/10.1371/journal.pone.0292132 |
| spellingShingle | Måns Stefansson Oscar Bladh Ola Flink Otto Skolling Hans-Peter Ekre Lars Rombo Lars Engstrand Johan Ursing Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. PLoS ONE |
| title | Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. |
| title_full | Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. |
| title_fullStr | Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. |
| title_full_unstemmed | Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. |
| title_short | Safety and tolerability of frozen, capsulized autologous faecal microbiota transplantation. A randomized double blinded phase I clinical trial. |
| title_sort | safety and tolerability of frozen capsulized autologous faecal microbiota transplantation a randomized double blinded phase i clinical trial |
| url | https://doi.org/10.1371/journal.pone.0292132 |
| work_keys_str_mv | AT mansstefansson safetyandtolerabilityoffrozencapsulizedautologousfaecalmicrobiotatransplantationarandomizeddoubleblindedphaseiclinicaltrial AT oscarbladh safetyandtolerabilityoffrozencapsulizedautologousfaecalmicrobiotatransplantationarandomizeddoubleblindedphaseiclinicaltrial AT olaflink safetyandtolerabilityoffrozencapsulizedautologousfaecalmicrobiotatransplantationarandomizeddoubleblindedphaseiclinicaltrial AT ottoskolling safetyandtolerabilityoffrozencapsulizedautologousfaecalmicrobiotatransplantationarandomizeddoubleblindedphaseiclinicaltrial AT hanspeterekre safetyandtolerabilityoffrozencapsulizedautologousfaecalmicrobiotatransplantationarandomizeddoubleblindedphaseiclinicaltrial AT larsrombo safetyandtolerabilityoffrozencapsulizedautologousfaecalmicrobiotatransplantationarandomizeddoubleblindedphaseiclinicaltrial AT larsengstrand safetyandtolerabilityoffrozencapsulizedautologousfaecalmicrobiotatransplantationarandomizeddoubleblindedphaseiclinicaltrial AT johanursing safetyandtolerabilityoffrozencapsulizedautologousfaecalmicrobiotatransplantationarandomizeddoubleblindedphaseiclinicaltrial |