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The Effects of Probiotic Supplementation on Anthropometric Growth and Gut Microbiota Composition in Patients With Prader-Willi Syndrome: A Randomized Double-Blinded Placebo-Controlled Trial.

ABSTRACT: Background: Prader-Willi Syndrome (PWS) is a rare genetic disorder associated with developmental delay, obesity, and neuropsychiatric comorbidities. Bifidobacterium animalis subsp. lactis has demonstrated anti-obesity and anti-inflammatory effects in previous studies. Aim: To evaluate the effects of Bifidobacterium animalis subsp. lactis probiotics supplementation on anthropometric growth, behavioral symptoms, and gut microbiome composition in patients with PWS. Methods: Ethical Approval was issued by the Internal Review Board (IRB) of the Second Affiliated Hospital of Kunming Medical University (Review-YJ-2016-06). We conducted a 12-week, randomized, double-blind, placebo-controlled trial in 68 patients with Prader-Willi syndrome aged 11 months-16 years (mean = 4.2 years old) who were randomly assigned to receive daily B. lactis-11 probiotics (6 × 10¹⁰ CFUs) or a placebo sachet. Weight, height, ASQ-3, ABC, SRS-2, and CGI-I were compared between the two groups at baseline and at 6 and 12 weeks into treatment. Gut microbiome data were analyzed with the QIIME 2 software package, and functional gene analysis was conducted with PICRUSt-2. Results: We found a significant increase in height (mean difference = 2.68 cm, P < 0.05) and improvement in CGI-I (P < 0.05) in the probiotics group compared to the placebo group. No significant change in weight or psychological measures were observed. Probiotic treatment altered the microbiome composition to favor weight loss and gut health and increased the abundance of antioxidant production-related genes. Conclusions: The findings suggest a novel therapeutic potential for Bifidobacterium animalis subsp. lactis probiotics in Prader-Willi syndrome patients, although further investigation is warranted.

SUBMITTER: Kong XJ

PROVIDER: S-EPMC7933553 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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The Effects of Probiotic Supplementation on Anthropometric Growth and Gut Microbiota Composition in Patients With Prader-Willi Syndrome: A Randomized Double-Blinded Placebo-Controlled Trial.

Kong Xue-Jun XJ Wan Guobin G Tian Ruiyi R Liu Siyu S Liu Kevin K Clairmont Cullen C Lin Xiaojing X Zhang Xiaoying X Sherman Hannah H Zhu Junli J Wang Yelan Y Fong Michelle M Li Alice A Wang Bryan K BK Wang Jinghan J Liu Jun J Yu Zhehao Z Shen Chen C Cui Xianghua X Cao Hanyu H Du Ting T Cao Xia X

Frontiers in nutrition 20210219

Background: Prader-Willi Syndrome (PWS) is a rare genetic disorder associated with developmental delay, obesity, and neuropsychiatric comorbidities. Bifidobacterium animalis subsp. lactis has demonstrated anti-obesity and anti-inflammatory effects in previous studies. Aim: To evaluate the effects of Bifidobacterium animalis subsp. lactis probiotics supplementation on anthropometric growth, behavioral symptoms, and gut microbiome composition in patients w ...[more]

PMID: 33681271

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Project description:Prader-Willi syndrome (PWS) is a rare, complex multisystem genetic disorder which includes hypothalamic dysfunction, hyperphagia, cognitive and behavioral problems, increased anxiety, and compulsive behaviors. Individuals with PWS have a deficit of oxytocin producing neurons in the paraventricular nucleus of the hypothalamus. Oxytocin plays a role in regulation of feeding behaviors, social interactions, and emotional reactivity, which are all issues that significantly affect the quality of life for individuals with this syndrome. We performed a double-blind, placebo-controlled, crossover study in 24 children with PWS at three academic institutions using 5 days of intranasal oxytocin (IN-OT) or 5 days of intranasal placebo spray, followed by a 4 week washout period, and then patients returned for 5 days of treatment with the alternate source. Questionnaires, including the Aberrant Behavior Checklist, Social Responsiveness Scale, Repetitive Behavior Scale - Revised, and the Hyperphagia Questionnaire, as well as Clinical Global Impression scales were administered. Blood testing for sodium, potassium, and glucose levels on days 2, 4, and 6, and a 24?hr diet recall. All scales factor improvement from Day 3 to Day 6 favored oxytocin over placebo. No single factor showed a statistically significant difference (P?<?0.05) between groups at Day 6. The drug effect appeared to be diminished at Day 14. There was no evidence of a difference between oxytocin and placebo in safety lab parameters, 60?min post dose vital signs, weight, or diet parameters. The results from this study suggest that low dose intranasal oxytocin is safe for individuals with PWS and may result in reduction in appetite drive, and improvements in socialization, anxiety, and repetitive behaviors. Further, long-term studies with a larger population of participants are necessary to confirm these findings. The results of this study are encouraging that oxytocin may be a safe and effective treatment for many of the issues that negatively impact individuals with PWS.

Project description:To evaluate the influence of oral probiotic Bifidobacterium animalis subsp. lactis (BL-11) supplementation on salivary microbiota composition and the association with growth parameters, and behavioral symptoms in individuals with Prader-Willi syndrome (PWS). In this post hoc analysis, we included a subset of 36 PWS patients with available saliva samples from our original randomized, double-blinded, placebo-controlled trial (Chinese Clinical Trial Registry, ChiCTR1900022646, April 20, 2019). Among the 36 subjects, 17 subjects were allocated to the probiotic group for daily use of the BL-11 probiotic and 19 subjects were allocated to the placebo group. Groupwise and longitudinal differences in salivary microbiota abundances, biodiversity metrics, and height were analyzed. Linear correlations were found between identified differentially abundant salivary microbiota and clinical parameters. Salivary microbiome α-diversity was found to be higher in the probiotic-treated group at week 12 relative to placebo controls (P < 0.05). Leptotrichia, Paracoccus, and Faecalibacterium were found to be more abundant in the probiotic-treated group (P < 0.05). Salivary microbiota abundance and predicted functional profiling abundance correlations were found to be associated with anti-inflammation, anti-obesity, toxin degradation, and anti-oxidative injury effects (Q < 0.1). Several oral taxa also displayed correlations with social behavior severity scores in the probiotic-treated group (Q < 0.1). The findings suggest novel salivary microbiota compositional changes in response to the oral supplementation of BL-11 probiotic in individuals with PWS. The observed differentially abundant taxa between groups post-treatment were highly correlated with interventional effects on growth and social behaviors, although further investigation is warranted. Clinical Trial Registration The original clinical trial was registered under the Chinese Clinical Trial Registry with registration number ChiCTR1900022646 (April 20, 2019).

Project description:BACKGROUND:Probiotics are an upcoming group of nutraceuticals claiming positive effects on athlete's gut health, redox biology and immunity but there is lack of evidence to support these statements. METHODS:We conducted a randomized, double-blinded, placebo controlled trial to observe effects of probiotic supplementation on markers of intestinal barrier, oxidation and inflammation, at rest and after intense exercise. 23 trained men received multi-species probiotics (1010 CFU/day, Ecologic®Performance or OMNi-BiOTiC®POWER, n?=?11) or placebo (n?=?12) for 14?weeks and performed an intense cycle ergometry over 90 minutes at baseline and after 14?weeks. Zonulin and ?1-antitrypsin were measured from feces to estimate gut leakage at baseline and at the end of treatment. Venous blood was collected at baseline and after 14?weeks, before and immediately post exercise, to determine carbonyl proteins (CP), malondialdehyde (MDA), total oxidation status of lipids (TOS), tumor necrosis factor-alpha (TNF-?), and interleukin-6 (IL-6). Statistical analysis used multifactorial analysis of variance (ANOVA). Level of significance was set at p?<?0.05, a trend at p?<?0.1. RESULTS:Zonulin decreased with supplementation from values slightly above normal into normal ranges (<30?ng/ml) and was significantly lower after 14?weeks with probiotics compared to placebo (p?=?0.019). We observed no influence on ?1-antitrypsin (p?>?0.1). CP increased significantly from pre to post exercise in both groups at baseline and in the placebo group after 14?weeks of treatment (p?=?0.006). After 14?weeks, CP concentrations were tendentially lower with probiotics (p?=?0.061). TOS was slightly increased above normal in both groups, at baseline and after 14?weeks of treatment. There was no effect of supplementation or exercise on TOS. At baseline, both groups showed considerably higher TNF-? concentrations than normal. After 14?weeks TNF-? was tendentially lower in the supplemented group (p?=?0.054). IL-6 increased significantly from pre to post exercise in both groups (p?=?0.001), but supplementation had no effect. MDA was not influenced, neither by supplementation nor by exercise. CONCLUSIONS:The probiotic treatment decreased Zonulin in feces, a marker indicating enhanced gut permeability. Moreover, probiotic supplementation beneficially affected TNF-? and exercise induced protein oxidation. These results demonstrate promising benefits for probiotic use in trained men. CLINICAL TRIAL REGISTRY:http://www.clinicaltrials.gov, identifier: NCT01474629.

Dataset Information

The Effects of Probiotic Supplementation on Anthropometric Growth and Gut Microbiota Composition in Patients With Prader-Willi Syndrome: A Randomized Double-Blinded Placebo-Controlled Trial.

Publications

The Effects of Probiotic Supplementation on Anthropometric Growth and Gut Microbiota Composition in Patients With Prader-Willi Syndrome: A Randomized Double-Blinded Placebo-Controlled Trial.

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