Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250413
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-18
Brief Title:
Autoflor -Lyophilized Capsulated Autological FMT to Restore Gut Microbiome After Treatment With Antibiotics
Sponsor:
Otto Helve
Organization:
Helsinki University Central Hospital
Study Overview
Official Title:
Lyophilized Capsulated Autological Fecal Microbial Transplant to Restore Gut Microbiome After Treatment With Antibiotics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FMT
Brief Summary:
In this clinical trial our aim is to assess the effect of auto-FMT Fecal microbiome transplantation on the intestinal microbiota after a course of antibiotics
30 healthy adults are recruited All are given a five day course of amoxicillin-clavulanate The subjects are double blinded and randomized to two groups Group A is given autologous FMT auto-FMT on day 7 two days after the end of the course of antibiotics and Group B is given auto-FMT on day 28 23 days after the end of the course of antibiotics
30 healthy adults are recruited All are given a five day course of amoxicillin-clavulanate The subjects are double blinded and randomized to two groups Group A is given autologous FMT auto-FMT on day 7 two days after the end of the course of antibiotics and Group B is given auto-FMT on day 28 23 days after the end of the course of antibiotics
Detailed Description:
The use of antibiotics also has short- and long-term disadvantages for the individual In trials with human adults oral intake of antibiotics has been shown to markedly affect the intestinal microbiota by reducing the diversity and altering the composition as well as by spreading of antibiotic resistance genes AR
Freeze dried FMT products have long lasting stability of fecal microbiota useful for encapsulation The amount of capsules needed to digest is also much lower compared to using fresh or frozen material
Anticipating a 25 drop-out we will recruit 40 healthy adults between 18-40 years of age Inflammation status of the participants at recruitment will be tested by taking blood samples A 100-150g sample of the participants feces is obtained The feces will be tested for potential harmful pathogens
50g of collected stool is processed within 6 h of passage diluted in 085 NaCl homogenized using a mixer The fecal suspension is filtered through sterilized metal sieves under biological safety cabinet The suspension is then centrifuged Supernatant is then decanted into new centrifuge tubes and centrifuged The upper bacterial pellet is resuspended in isotonic sodium chloride with 10 trehalose The suspension is stored at -80C up to two weeks before being lyophilized The solution is lyophilized in a Lyoquest plus Ae85C Telstar Tarrasa Spain for 44 h and the resulting product is encapsulated in hypromellose capsules sizes 0 Capsugel Enprotect Cambridge MA USA and stored at 4C The protocol is applied from previous studies with capsulated FMT Each capsule contains approximately 035g lyophilized stool extract Oboy hot chocolate powder is used as placebo
The 30 participants are randomized and double blinded into two groups each having 15 subjects All participants will be given a 5-day Day 1-5 course of Amoxicillin Clavulanate 875125 mg 2
Group A Intervention group The participants will be given 4 capsules containing fecal matter Capsule 1 after treatment with antibiotics on day 7
Group B Control group The participants will be given 4 placebo capsules Capsule 2 after treatment with antibiotics on day 7
Group B will be given FMT capsules Capsules 1 as rescue therapy on day 28 Group A will be given placebo Capsules 2 as described earlier
The capsules at timepoints 7 and 28 days are administered under the supervision of the research team The capsules are swallowed with juice Participants are asked to be on a clear liquid diet for 8 h prior to the intervention No solid food should be taken within two hours of digesting the capsules Otherwise no restrictions to the diet are considered necessary During the visit the participants are interviewed and ensured that no signs of infection have occurred and that there have been no significant changes in bowel function
Fecal samples will be collected from all participants weekly starting from day 6 for 7 weeks until day 48 total 7 samples 3 vialssample The study samples are stored in stool collection containers in the home freezer -18C until collected by the study personnel and stored there after at -80C Calprotectin samples are stored in the refrigerator until collected by the study personnel
The participants will fill in a questionnaire including questions of any abdominal symptoms defecation frequency stool consistence abdominal pain nausea and other used medication weekly until 7 weeks Use of additional antibiotics during the follow-up period leads to drop-out Participants complete a quality of life HRQoL survey at day 1 the introduction of antibiotics on day 7 when auto-FMTplacebo first intervention is performed on day 28 second intervention and at the end of the follow-up period day 48 httpwww15d-instrumentnet15d
Participants with fever watery diarrhea 3 loose stools in 24 hours bloody stools abdominal pain and cramping are tested for C difficile In case of fever the CRP level and complete blood count are controlled Participants with bloody stools will be excluded from the study
Blood samples will be taken on days 7 9 28 and 30 5mL of blood is gathered C-reactive protein complete blood count plasma
Freeze dried FMT products have long lasting stability of fecal microbiota useful for encapsulation The amount of capsules needed to digest is also much lower compared to using fresh or frozen material
Anticipating a 25 drop-out we will recruit 40 healthy adults between 18-40 years of age Inflammation status of the participants at recruitment will be tested by taking blood samples A 100-150g sample of the participants feces is obtained The feces will be tested for potential harmful pathogens
50g of collected stool is processed within 6 h of passage diluted in 085 NaCl homogenized using a mixer The fecal suspension is filtered through sterilized metal sieves under biological safety cabinet The suspension is then centrifuged Supernatant is then decanted into new centrifuge tubes and centrifuged The upper bacterial pellet is resuspended in isotonic sodium chloride with 10 trehalose The suspension is stored at -80C up to two weeks before being lyophilized The solution is lyophilized in a Lyoquest plus Ae85C Telstar Tarrasa Spain for 44 h and the resulting product is encapsulated in hypromellose capsules sizes 0 Capsugel Enprotect Cambridge MA USA and stored at 4C The protocol is applied from previous studies with capsulated FMT Each capsule contains approximately 035g lyophilized stool extract Oboy hot chocolate powder is used as placebo
The 30 participants are randomized and double blinded into two groups each having 15 subjects All participants will be given a 5-day Day 1-5 course of Amoxicillin Clavulanate 875125 mg 2
Group A Intervention group The participants will be given 4 capsules containing fecal matter Capsule 1 after treatment with antibiotics on day 7
Group B Control group The participants will be given 4 placebo capsules Capsule 2 after treatment with antibiotics on day 7
Group B will be given FMT capsules Capsules 1 as rescue therapy on day 28 Group A will be given placebo Capsules 2 as described earlier
The capsules at timepoints 7 and 28 days are administered under the supervision of the research team The capsules are swallowed with juice Participants are asked to be on a clear liquid diet for 8 h prior to the intervention No solid food should be taken within two hours of digesting the capsules Otherwise no restrictions to the diet are considered necessary During the visit the participants are interviewed and ensured that no signs of infection have occurred and that there have been no significant changes in bowel function
Fecal samples will be collected from all participants weekly starting from day 6 for 7 weeks until day 48 total 7 samples 3 vialssample The study samples are stored in stool collection containers in the home freezer -18C until collected by the study personnel and stored there after at -80C Calprotectin samples are stored in the refrigerator until collected by the study personnel
The participants will fill in a questionnaire including questions of any abdominal symptoms defecation frequency stool consistence abdominal pain nausea and other used medication weekly until 7 weeks Use of additional antibiotics during the follow-up period leads to drop-out Participants complete a quality of life HRQoL survey at day 1 the introduction of antibiotics on day 7 when auto-FMTplacebo first intervention is performed on day 28 second intervention and at the end of the follow-up period day 48 httpwww15d-instrumentnet15d
Participants with fever watery diarrhea 3 loose stools in 24 hours bloody stools abdominal pain and cramping are tested for C difficile In case of fever the CRP level and complete blood count are controlled Participants with bloody stools will be excluded from the study
Blood samples will be taken on days 7 9 28 and 30 5mL of blood is gathered C-reactive protein complete blood count plasma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None