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Randomized Controlled Trial
. 2020 Dec;8(12):e1535.
doi: 10.1002/mgg3.1535. Epub 2020 Oct 25.

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

Zainab Alyousif  1 , Jennifer L Miller  2 , Jeremie Auger  3 , Mariana Sandoval  3 , Amanda Piano  3 , Thomas A Tompkins  3 , Wendy J Dahl  1
Affiliations
Randomized Controlled Trial

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

Zainab Alyousif et al. Mol Genet Genomic Med. 2020 Dec.

Abstract

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.

Keywords: Bristol Stool Form; HEI-2015; Prader-Willi syndrome; constipation; probiotic; stool frequency.

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Figures

FIGURE 1
FIGURE 1
Participant recruitment, randomization, and study flow
FIGURE 2
FIGURE 2
Abundance of Bifidobacterium animalis by study period. (a) Group that received Placebo → Probiotic (n = 12). (b) Group that received Probiotic → Placebo (n = 12)
FIGURE 3
FIGURE 3
Relative fold change of Akkermansia muciniphila, Fecalibacterium prausnitzii, and Bifidobacterium genus over each intervention period in participants with complete stool collections (n = 24)
FIGURE 4
FIGURE 4
A Pirateplot relative comparison of Pielou, Faith, and Shannon diversity indices during baseline, probiotic, placebo, and washout periods
FIGURE 5
FIGURE 5
Taxonomic classification by phyla, order, and genus of fecal microbiome of adults affected by Prader‐Willi syndrome during placebo, baseline, washout, and probiotic periods
See this image and copyright information in PMC

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