Microbiota profile and efficacy of probiotic supplementation on laxation in adults affected by Prader-Willi Syndrome: A randomized, double-blind, crossover trial

Background Probiotics may provide a benefit for adults with Prader-Willi syndrome (PWS) experiencing constipation. The primary aim was to determine if Bifidobacterium animalis ssp. lactis B94 (B.lactis B94) improves stool frequency, with secondary aims of stool form and gastrointestinal symptoms. Exploratory aims included diet quality and fecal microbiota composition. Methods Following a 4-week baseline, 25 adults with PWS were randomized to consume B.lactis B94 by capsule (15 billion) or placebo for 4 weeks, followed by 4-week washout in a double-blind, crossover design. Stool frequency and Bristol Stool Form (BSF) were assessed daily, and Gastrointestinal Symptom Rating Scale (GSRS) and dietary intake (7-days food records), per period. Fecal microbiota per period was analyzed using 16S rRNA gene amplicon sequencing and taxa of interest by qPCR (n = 24). Results No adverse events were reported. Stool frequency at baseline (n = 25; 2.0 +/- 0.1 stools/day), GSRS syndromes, and microbiota composition did not differ with the probiotic intervention overall; however, a delayed, carry-over effect on BSF types 6 and 7 was seen. Diet quality by HEI-2015 was 65.4 +/- 8.5. Conclusion In adults with PWS, B.lactis B94 exhibited little effect on laxation over 4 weeks; however, further research is needed.