Health TrialsbyHealthPanel

Autoflor -Lyophilized Capsulated Autological FMT to Restore Gut Microbiome After Treatment With Antibiotics

ConditionsMicrobial ColonizationAntibiotic Side Effect
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

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

IBD (inflammatory bowel disease)

celiac disease

abdominal symptoms such as diarrhea or constipation necessitating medical therapy

pregnancy and breastfeeding

Trial design

Design model

Crossover

Treatments tested in this trial

  • FMT

    Other intervention

    Capsulated oral auto fecal microbiota transplant

  • Placebo

    Other intervention

    Capsulated hot chocolate powder

  • Amox Clav

    Drug

    5 day course of Amoxicillin Clavulanic acid given to all participants

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 3 interventions
Group B: ControlPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
2 months
2

Taxonomic restoration of the gut microbiome at day 27.

Quantitative PCR will be used for quantitative microbiota profiling.

Time frame
1 month

Secondary outcomes

1

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).

Time frame
3 months
2

Magnitude and duration of GI-symptoms

The investigators will use questionaires filled by the participants.

Time frame
3 months
3

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.

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Otto Helve

Lead sponsor

Helsinki University Central Hospital

Sponsor institution

University of Helsinki

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: