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

NCT06250413 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-14

No results posted yet for this study

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).

Conditions

  • Microbial Colonization
  • Antibiotic Side Effect

Interventions

OTHER

FMT

Capsulated oral auto fecal microbiota transplant

OTHER

Placebo

Capsulated hot chocolate powder

DRUG

Amox Clav

5 day course of Amoxicillin Clavulanic acid given to all participants

Sponsors & Collaborators

  • University of Helsinki

    collaborator OTHER

  • Otto Helve

    lead OTHER

Principal Investigators

  • Otto Helve, Docent · University of Helsinki

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06250413 on ClinicalTrials.gov