Lyophilized Capsulated Autological Fecal Microbial Transplant to Restore Gut Microbiome After Treatment With Antibiotics

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.