Microbial ColonizationFMTNCT06250413
Autoflor -Lyophilized Capsulated Autological FMT to Restore Gut Microbiome After Treatment With Antibiotics
A study testing FMT and Amox Clav in people with Microbial Colonization and Antibiotic Side Effect, run by Otto Helve at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization, Antibiotic Side Effect
- What is being tested?
- FMT and Amox Clav
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -previously healthy
Who cannot join
- IBD (inflammatory bowel disease)
- celiac disease
- abdominal symptoms such as diarrhea or constipation necessitating medical therapy
- pregnancy and breastfeeding
- allergy towards antibiotics penicillins
- allergy towards soya.
Show all 10Show fewer
- trehalose intolerance.
- travelling outside of European Union during the last 3 months
- use of antibiotics during the last 3 months
- use of probiotics during the previous 2 weeks or during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site
Helsinki University Hospital
Helsinki, Uusimaa
Noora Carpén, +358 9 4711, noora.carpen@hus.fi
Kaija-Leena Kolho, Professor, kaija-leena.kolho@hus.fi
About this study
Official title: Lyophilized Capsulated Autological Fecal Microbial Transplant to Restore Gut Microbiome After Treatment With Antibiotics
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).
Read the 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 0.85% 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 -80°C 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 4°C. The protocol is applied from previous studies with capsulated FMT. Each capsule contains approximately 0.35g lyophilized stool extract. O'boy 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 875/125 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 vials/sample)). The study samples are stored in stool collection containers in the home freezer (-18°C) until collected by the study personnel and stored there after at -80°C. 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-FMT/placebo (first intervention) is performed, on day 28 (second intervention) and at the end of the follow-up period (day 48) (http://www.15d-instrument.net/15d/).
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).
- Conditions
- Microbial Colonization, Antibiotic Side Effect
- Being tested
- FMT, Placebo, Amox Clav
- Keywords
- FMT, lyophilized, antibiotics
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMTOther
Capsulated oral auto fecal microbiota transplant
PlaceboOther
Capsulated hot chocolate powder
Amox ClavDrug
Also called Amorion comp
5 day course of Amoxicillin Clavulanic acid given to all participants
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The participants will be given 4 capsules containing fecal matter (Capsule 1) after treatment with antibiotics on day 7. Intervention group will be given placebo (Capsules 2) on day 28. Receives: Other: FMT; Other: Placebo; Drug: Amox Clav |
| Control | Placebo comparator | The participants will be given 4 placebo capsules (Capsule 2) after treatment with antibiotics on day 7.
Control group will be given FMT capsules (Capsules 1) as "rescue therapy" on day 28. Receives: Other: FMT; Other: Placebo; Drug: Amox Clav |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and safety; Number of participants with treatment-related adverse events such as; nausea, vomiting, signs of infection such as elevation of CRP after receiving the capsules, bloody stools
The feasibility and safety of the transplantation process using lyophilized auto-FMT. All adverse events are reported, CRP is taken from all patients at the day of the transplant and 2 day after. The participants answer to weekly online questionaires including questions of any abdominal symptoms, defecation frequency, stool consistence, abdominal pain, nausea and other used medication weekly until 7 weeks.
Measured: 2 months
Taxonomic restoration of the gut microbiome at day 27.
Quantitative PCR will be used for quantitative microbiota profiling.
Measured: 1 month
Secondary outcomes (3)
The percentage of participants with restoration of intestinal microbiome.
The investigators observe especially the influence of auto-FMT towards successful restoration of bacteria from beneficial groups, including Lachnospiraceae (family), Ruminococcaceae (family), and Bacteroidetes (phylum).
Measured: 3 months
Magnitude and duration of GI-symptoms
The investigators will use questionaires filled by the participants.
Measured: 3 months
Impact of FMT given to placebo group on day 28 on gut microbiome on day 48
Quantitative PCR will be used for quantitative microbiota profiling.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Otto Helve
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Sponsor-investigator, Otto Helve, Helsinki University Central Hospital
- Investigators
- Otto Helve, Docent, Study director, University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250413
- Sponsor's protocol ID
- HUS/2231/2023
- Acronym
- FMT
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jernberg C, Lofmark S, Edlund C, Jansson JK. Long-term impacts of antibiotic exposure on the human intestinal microbiota. Microbiology (Reading). 2010 Nov;156(Pt 11):3216-3223. doi: 10.1099/mic.0.040618-0. Epub 2010 Aug 12.
PubMed 20705661Reygner J, Charrueau C, Delannoy J, Mayeur C, Robert V, Cuinat C, Meylheuc T, Mauras A, Augustin J, Nicolis I, Modoux M, Joly F, Waligora-Dupriet AJ, Thomas M, Kapel N. Freeze-dried fecal samples are biologically active after long-lasting storage and suited to fecal microbiota transplantation in a preclinical murine model of Clostridioides difficile infection. Gut Microbes. 2020 Sep 2;11(5):1405-1422. doi: 10.1080/19490976.2020.1759489. Epub 2020 Jun 5.
PubMed 32501140Suez J, Zmora N, Zilberman-Schapira G, Mor U, Dori-Bachash M, Bashiardes S, Zur M, Regev-Lehavi D, Ben-Zeev Brik R, Federici S, Horn M, Cohen Y, Moor AE, Zeevi D, Korem T, Kotler E, Harmelin A, Itzkovitz S, Maharshak N, Shibolet O, Pevsner-Fischer M, Shapiro H, Sharon I, Halpern Z, Segal E, Elinav E. Post-Antibiotic Gut Mucosal Microbiome Reconstitution Is Impaired by Probiotics and Improved by Autologous FMT. Cell. 2018 Sep 6;174(6):1406-1423.e16. doi: 10.1016/j.cell.2018.08.047.
PubMed 30193113Bulow C, Langdon A, Hink T, Wallace M, Reske KA, Patel S, Sun X, Seiler S, Jones S, Kwon JH, Burnham CA, Dantas G, Dubberke ER. Impact of Amoxicillin-Clavulanate followed by Autologous Fecal Microbiota Transplantation on Fecal Microbiome Structure and Metabolic Potential. mSphere. 2018 Nov 21;3(6):e00588-18. doi: 10.1128/mSphereDirect.00588-18.
PubMed 30463925Taur Y, Coyte K, Schluter J, Robilotti E, Figueroa C, Gjonbalaj M, Littmann ER, Ling L, Miller L, Gyaltshen Y, Fontana E, Morjaria S, Gyurkocza B, Perales MA, Castro-Malaspina H, Tamari R, Ponce D, Koehne G, Barker J, Jakubowski A, Papadopoulos E, Dahi P, Sauter C, Shaffer B, Young JW, Peled J, Meagher RC, Jenq RR, van den Brink MRM, Giralt SA, Pamer EG, Xavier JB. Reconstitution of the gut microbiota of antibiotic-treated patients by autologous fecal microbiota transplant. Sci Transl Med. 2018 Sep 26;10(460):eaap9489. doi: 10.1126/scitranslmed.aap9489.
PubMed 30257956
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lyophilized Capsulated Autological Fecal Microbial Transplant to Restore Gut Microbiome After Treatment With Antibiotics
- ClinicalTrials.gov ID
- NCT06250413
- Acronym / sponsor ID
- FMT / HUS/2231/2023
- Conditions
- Microbial Colonization, Antibiotic Side Effect
- Keywords
- FMT, lyophilized, antibiotics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Otto HelveUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- Feb 2024 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 0.85% 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 -80°C 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 4°C. The protocol is applied from previous studies with capsulated FMT. Each capsule contains approximately 0.35g lyophilized stool extract. O'boy 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 875/125 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 vials/sample)). The study samples are stored in stool collection containers in the home freezer (-18°C) until collected by the study personnel and stored there after at -80°C. 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-FMT/placebo (first intervention) is performed, on day 28 (second intervention) and at the end of the follow-up period (day 48) (http://www.15d-instrument.net/15d/).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: FMT, Other: Placebo, Drug: Amox ClavThe participants will be given 4 capsules containing fecal matter (Capsule 1) after treatment with antibiotics on day 7. Intervention group will be given placebo (Capsules 2) on day 28. |
| Control | Placebo comparator | Other: FMT, Other: Placebo, Drug: Amox ClavThe participants will be given 4 placebo capsules (Capsule 2) after treatment with antibiotics on day 7. Control group will be given FMT capsules (Capsules 1) as "rescue therapy" on day 28. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -previously healthy
Key exclusion criteria (10 listed)
- IBD (inflammatory bowel disease)
- celiac disease
- abdominal symptoms such as diarrhea or constipation necessitating medical therapy
- pregnancy and breastfeeding
- allergy towards antibiotics penicillins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMTCapsulated oral auto fecal microbiota transplant | Other | Control, Intervention |
| PlaceboCapsulated hot chocolate powder | Other | Control, Intervention |
| Amox ClavAlso: Amorion comp5 day course of Amoxicillin Clavulanic acid given to all participants | Drug | Control, Intervention |
Primary outcome
Feasibility and safety; Number of participants with treatment-related adverse events such as; nausea, vomiting, signs of infection such as elevation of CRP after receiving the capsules, bloody stools
Time frame: 2 months
The feasibility and safety of the transplantation process using lyophilized auto-FMT. All adverse events are reported, CRP is taken from all patients at the day of the transplant and 2 day after. The participants answer to weekly online questionaires including questions of any abdominal symptoms, defecation frequency, stool consistence, abdominal pain, nausea and other used medication weekly until 7 weeks.
Taxonomic restoration of the gut microbiome at day 27.
Time frame: 1 month
Quantitative PCR will be used for quantitative microbiota profiling.
3 secondary outcomes
The percentage of participants with restoration of intestinal microbiome.
Time frame: 3 months
Magnitude and duration of GI-symptoms
Time frame: 3 months
Impact of FMT given to placebo group on day 28 on gut microbiome on day 48
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Background: PubMed 20705661Jernberg C, Lofmark S, Edlund C, Jansson JK. Long-term impacts of antibiotic exposure on the human intestinal microbiota. Microbiology (Reading). 2010 Nov;156(Pt 11):3216-3223. doi: 10.1099/mic.0.040618-0. Epub 2010 Aug 12.
- Background: PubMed 32501140Reygner J, Charrueau C, Delannoy J, Mayeur C, Robert V, Cuinat C, Meylheuc T, Mauras A, Augustin J, Nicolis I, Modoux M, Joly F, Waligora-Dupriet AJ, Thomas M, Kapel N. Freeze-dried fecal samples are biologically active after long-lasting storage and suited to fecal microbiota transplantation in a preclinical murine model of Clostridioides difficile infection. Gut Microbes. 2020 Sep 2;11(5):1405-1422. doi: 10.1080/19490976.2020.1759489. Epub 2020 Jun 5.
- Results publication: PubMed 30193113Suez J, Zmora N, Zilberman-Schapira G, Mor U, Dori-Bachash M, Bashiardes S, Zur M, Regev-Lehavi D, Ben-Zeev Brik R, Federici S, Horn M, Cohen Y, Moor AE, Zeevi D, Korem T, Kotler E, Harmelin A, Itzkovitz S, Maharshak N, Shibolet O, Pevsner-Fischer M, Shapiro H, Sharon I, Halpern Z, Segal E, Elinav E. Post-Antibiotic Gut Mucosal Microbiome Reconstitution Is Impaired by Probiotics and Improved by Autologous FMT. Cell. 2018 Sep 6;174(6):1406-1423.e16. doi: 10.1016/j.cell.2018.08.047.
- Results publication: PubMed 30463925Bulow C, Langdon A, Hink T, Wallace M, Reske KA, Patel S, Sun X, Seiler S, Jones S, Kwon JH, Burnham CA, Dantas G, Dubberke ER. Impact of Amoxicillin-Clavulanate followed by Autologous Fecal Microbiota Transplantation on Fecal Microbiome Structure and Metabolic Potential. mSphere. 2018 Nov 21;3(6):e00588-18. doi: 10.1128/mSphereDirect.00588-18.
- Results publication: PubMed 30257956Taur Y, Coyte K, Schluter J, Robilotti E, Figueroa C, Gjonbalaj M, Littmann ER, Ling L, Miller L, Gyaltshen Y, Fontana E, Morjaria S, Gyurkocza B, Perales MA, Castro-Malaspina H, Tamari R, Ponce D, Koehne G, Barker J, Jakubowski A, Papadopoulos E, Dahi P, Sauter C, Shaffer B, Young JW, Peled J, Meagher RC, Jenq RR, van den Brink MRM, Giralt SA, Pamer EG, Xavier JB. Reconstitution of the gut microbiota of antibiotic-treated patients by autologous fecal microbiota transplant. Sci Transl Med. 2018 Sep 26;10(460):eaap9489. doi: 10.1126/scitranslmed.aap9489.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Otto Helve, Docent study director
University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMT and Amox Clav in people with Microbial Colonization and Antibiotic Side Effect, run by Otto Helve at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noora Carpén, MD (+358 9 4711, noora.carpen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and safety; Number of participants with treatment-related adverse events such as; nausea, vomiting, signs of infection such as elevation of CRP after receiving the capsules, bloody stools (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250413, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.