Building on our findings in mice, we conducted an open-label pilot study to investigate the effects of FMT from healthy female donors on FM symptoms in women. Fourteen women with severe, refractory FM were enrolled.
Following depletion of the endogenous microbial communities using antibiotics and bowel cleansing, patients received five FMTs, once every 2 weeks, via oral administration of encapsulated transplants from healthy donor (age 34.7 ± 14.2 years; treatment regimen is described in STAR Methods and shown in Figure 6A; laboratory tests for donor screening are shown in Figure S16A). Of the 14 participants, 11 completed all five FMT doses, while all 14 were followed up and included in the analyses (Figure 6B).
Assessment of stool samples pre- and post-FMT, as well as donors’ stool and FMT capsules, revealed effective bacterial engraftment among FMT-recipient patients.
Post-FMT, patients' microbiomes clustered more closely with their respective donors, resulting in three distinct clusters corresponding to the three donors.
post-treatment samples from FMT-recipient patients clustered with their respective donors 4 and 9 weeks after treatment induction, indicating effective engraftment
adverse effects mainly included increased fatigue and mild gastrointestinal symptoms
1 week after the last FMT, pain intensity decreased by ≥2 points (out of 10, using pain numerical rating scale) in 12 of the 14 participants
Overall, the symptomatic burden decreased, and anxiety, depression, sleep quality, and physical quality-of-life scores improved
