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

Launched by OTTO HELVE · Jan 31, 2024

Keywords

ClinConnect Summary

This clinical trial, called Autoflor, is studying how a treatment known as fecal microbiome transplantation (FMT) can help restore the balance of good bacteria in the gut after taking antibiotics. Antibiotics are often used to treat infections, but they can sometimes upset the natural balance of bacteria in our intestines, leading to digestive issues. In this study, 30 healthy adults will receive a course of antibiotics for five days, and then they will be divided into two groups. One group will receive the FMT treatment two days after finishing the antibiotics, while the other group will receive it 23 days later.

To be eligible for this trial, participants must be generally healthy and between the ages of 18 and 65. However, individuals with certain conditions, such as inflammatory bowel disease or those who are pregnant or breastfeeding, cannot participate. The trial is not yet recruiting, so it’s still in the planning stages. Participants can expect to help researchers understand if and when FMT can effectively help restore gut health after antibiotic use. If you're interested in the study, it’s important to keep in mind the specific health criteria and restrictions that apply.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • -previously healthy
• Exclusion Criteria:
• • 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.
• • 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.