Autoflor -Lyophilized Capsulated Autological FMT to Restore Gut Microbiome After Treatment With Antibiotics
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorOtto Helve
About this trial
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).
Eligibility criteria
Qualifiers
None
Disqualifiers
IBD (inflammatory bowel disease)
celiac disease
abdominal symptoms such as diarrhea or constipation necessitating medical therapy
pregnancy and breastfeeding
Trial design
Treatments tested in this trial
- FMT
- Placebo
- Amox Clav
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Otto Helve
Lead sponsor
Helsinki University Central Hospital
Sponsor institution
University of Helsinki
Collaborator
Source ClinicalTrials.gov