Effectiveness of Sustained Release Calcium Butyrate on the microbiome and clinical burden in osteoarthritis of the hand: A proof-of-concept placebo-controlled randomized trial
Authors' conclusion
Our study yielded indicative findings that SRCaBu supports microbiome health in patient with hand OA by improving compositional and functional characteristics of the microbiome.
Study context
- Population
- Patients with hand OA (mean age 62.5±6.9 years, 82% female)2 Sustained Release Calcium Butyrate (SRCaBu) discontinued
- Participants
- 35 patients
- Comparison
- SRCaBu 600 mg daily vs placebo over 4-5 weeks
- SRCaBun = 18
- Placebon = 17reference
Methodological detailsparticipant-, researcher- and pharmacy assistant-blinded, placebo-controlled, proof-of-concept, per-protocol primary analyses
- Participant-, researcher- and pharmacy assistant-blinded
- Placebo-controlled
- Proof-of-concept
- Per-protocol primary analyses
Primary result
As reported in the abstract
Regression coefficient (relative abundance of Streptococcus)
−0.67
95% CI −1.46,0.13
tended to reduce
Regression coefficient (relative abundance of Faecalibacterium)
−0.38
95% CI −0.83,0.07
tended to reduce
Median between-group difference (fecal acetate)
9.5
IQR −3.5,22.5; tended to increase
Secondary outcomes
Biomarkers of intestinal permeability, inflammation, and clinical outcomes
- SRCaBu did not significantly affect these
Safety
Adverse events
- Mild and comparable between groups
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
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