FMT Intestinal Microbiome Changes and Clinical Outcomes of Patients with Ulcerative Colitis after Fecal Microbiota Transplantation (Dec 2023, n=20, 10x enemas, 3 donors) "Clinical remission was achieved in 19 (95%) patients at week 8"

Fecal Microbiota Transplants

Michael Harrop

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https://www.mdpi.com/2077-0383/12/24/7702

Abstract​

Background and Aims: Ulcerative colitis (UC) is a chronic inflammatory disease that affects many people. One of the possible ways to treat UC is fecal microbiota transplantation (FMT). In this study, changes in the intestinal microbiome and clinical outcomes of 20 patients with UC after FMT were estimated.

Methods: FMT enemas were administrated ten times, once a day, and fecal microbiota from three donors was used for each enema. The clinical outcomes were assessed after eight weeks and then via a patient survey. The 16S rRNA profiles of the gut microbiota were compared between three samplings: samples from 20 patients with UC before and after FMT and samples from 18 healthy volunteers.

Results: Clinical remission was achieved in 19 (95%) patients at week 8. Adverse events occurred in five patients, including one non-responder. A significant increase in average biodiversity was shown in samples after FMT compared to samples before FMT, as well as a decrease in the proportion of some potentially pathogenic bacteria.

Conclusion: The efficacy of FMT for UC treatment was confirmed; however, the duration of remission varied substantially, possibly due to different characteristics of the initial microbiota of patients. Targeted analysis of a patient’s microbiome before FMT could increase the treatment efficacy.

Donor criteria were extremely basic:
Volunteers were young healthy people without chronic diseases (including autoimmune diseases), who had not been infected and/or hospitalized for at least six months and did not use antibiotics during this period. Fecal samples from volunteers were tested for the presence of the infectious agents Salmonella spp., Shigella spp., enteroinvasive Escherichia coli, and Cryptosporidium spp. using routine microbiological methods, as well as for helminths and their eggs using microscopy. C. difficile toxins A and B were detected using the immunochromatographic rapid test (Toxin A + B (Clostridium difficile) DUO, Vedalab, Alençon, France). In addition, the DNA of Shigella spp., enteroinvasive Escherichia coli, Salmonella spp., and Campylobacter were tested using PCR with hybridization fluorescence detection of amplification products (Amplisence OKI Bacto-Screen-FL, Moscow, Russia), and nucleic acids of rotaviruses A, noroviruses I and II, and adenoviruses F were screened for using the same method (Amplisence OKI Viro-Screen-FL, Moscow, Russia). All volunteers were additionally screened for H. pylori.

Volunteers who expressed a desire to become donors underwent further examination, which included general and biochemical blood tests, as well as blood ELISA for the presence of lamblia, toxocara, opisthorchia, ascaris, and trichinella. In addition, the absence of the syphilis causative agent, HIV-1 and HIV-2, and hepatitis B and C viruses was confirmed using standard kits.

Stool processing:
The course of FMT included ten enemas, one enema per day. The original donor material had been stored at −84 °C. For each procedure of FMT, the material from three donors was mixed in equal amounts. For each enema, a total of 90 g of stool samples from three donors (30 g from each) was suspended in 250 mL of sterile saline (0.9% NaCl) and the obtained suspension was homogenized using a household mixer at low speed. Then, the mixture was filtrated at least three times to remove large fecal lumps and residues. Each time, the product was freshly prepared 40–60 min before the FMT procedure and stored at room temperature and then, at 35 °C (last 30 min). The volume of each infusion was 190–200 mL.
 
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