scholarly journals Intervention with inulin prior to and during sanative therapy to further support periodontal health: study protocol for a randomized controlled trial

2021 ◽  
Author(s):  
Carly Zanatta ◽  
Peter Fritz ◽  
Elena Comelli ◽  
Wendy Ward
Keyword(s):  
Randomized Controlled Trial ◽  
Gut Microbiota ◽  
Periodontal Disease ◽  
Controlled Trial ◽  
Health Study ◽  
Controlled Study ◽  
Low Grade ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Markers Of Inflammation

Abstract Background: Periodontal disease is a chronic state of inflammation that can destroy the supporting tissues around the teeth, leading to the resorption of alveolar bone. The initial strategy for treating periodontal disease is non-surgical sanative therapy (ST). Periodontal disease can also induce dysbiosis in the gut microbiota and contribute to low grade systemic inflammation. Prebiotic fibres such as inulin can selectively alter the intestinal microbiota and support homeostasis by improving gut barrier functions and preventing inflammation. Providing an inulin supplement prior to and post-ST may influence periodontal health while providing insight into the complex relationship between periodontal disease and the gut microbiota. The primary objective is to determine if inulin is more effective than the placebo at improving clinical periodontal outcomes including probing depth (PD) and bleeding on probing (BOP). Secondary objectives include determining the effects of inulin supplementation pre and post-ST on salivary markers of inflammation and periodontal-associated pathogens, as these outcomes reflect more rapid changes that can occur.Methods: We will employ a single-center, randomized, double-blind, placebo-controlled study design and recruit and randomize 170 participants who are receiving ST to manage periodontal disease to the intervention (inulin) or placebo (maltodextrin) group. A pilot study will be embedded within the randomized controlled trial using the first 48 participants to test feasibility for the larger, powered trial. The intervention period will begin 4 weeks before ST through to their follow-up appointment at 10 weeks post-ST. Clinical outcomes of periodontal disease including number of sites with PD ≥ 4 mm and the absence of BOP will be measured at baseline and post-ST. Salivary markers of inflammation, periodontal-associated pathogens, body mass index and diet will be measured at baseline, pre-ST (after 4 weeks of intervention) and post-ST (after 14 weeks of intervention). Discussion: We expect that inulin to enhance the positive effect of ST on the management of periodontal disease. The results of the study will provide guidance regarding the use of prebiotics prior to and as a supportive adjunct to ST for periodontal health. Trial registration ClinicalTrials.gov: NCT04670133. Registered on 17 December 2020 https://clinicaltrials.gov/ct2/show/NCT04670133

scholarly journals Intervention with inulin prior to and during sanative therapy to further support periodontal health: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Carly A. R. Zanatta ◽  
Peter C. Fritz ◽  
Elena M. Comelli ◽  
Wendy E. Ward
Keyword(s):  
Randomized Controlled Trial ◽  
Gut Microbiota ◽  
Periodontal Disease ◽  
Controlled Trial ◽  
Health Study ◽  
Controlled Study ◽  
Low Grade ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Markers Of Inflammation

Abstract Background Periodontal disease is a chronic state of inflammation that can destroy the supporting tissues around the teeth, leading to the resorption of alveolar bone. The initial strategy for treating periodontal disease is non-surgical sanative therapy (ST). Periodontal disease can also induce dysbiosis in the gut microbiota and contribute to low-grade systemic inflammation. Prebiotic fibers such as inulin can selectively alter the intestinal microbiota and support homeostasis by improving gut barrier functions and preventing inflammation. Providing an inulin supplement prior to and post-ST may influence periodontal health while providing insight into the complex relationship between periodontal disease and the gut microbiota. The primary objective is to determine if inulin is more effective than the placebo at improving clinical periodontal outcomes including probing depth (PD) and bleeding on probing (BOP). Secondary objectives include determining the effects of inulin supplementation pre- and post-ST on salivary markers of inflammation and periodontal-associated pathogens, as these outcomes reflect more rapid changes that can occur. Methods We will employ a single-center, randomized, double-blind, placebo-controlled study design and recruit and randomize 170 participants who are receiving ST to manage the periodontal disease to the intervention (inulin) or placebo (maltodextrin) group. A pilot study will be embedded within the randomized controlled trial using the first 48 participants to test the feasibility for the larger, powered trial. The intervention period will begin 4 weeks before ST through to their follow-up appointment at 10 weeks post-ST. Clinical outcomes of periodontal disease including the number of sites with PD ≥ 4 mm and the presence of BOP will be measured at baseline and post-ST. Salivary markers of inflammation, periodontal-associated pathogens, body mass index, and diet will be measured at baseline, pre-ST (after 4 weeks of intervention), and post-ST (after 14 weeks of intervention). Discussion We expect that inulin will enhance the positive effect of ST on the management of periodontal disease. The results of the study will provide guidance regarding the use of prebiotics prior to and as a supportive adjunct to ST for periodontal health. Trial registration ClinicalTrials.gov NCT04670133. Registered on 17 December 2020.

scholarly journals Evaluation of the gut microbiota after metformin intervention in children with obesity: A metagenomic study of a randomized controlled trial

2021 ◽  
Vol 134 ◽  
pp. 111117
Author(s):  
Belén Pastor-Villaescusa ◽  
Julio Plaza-Díaz ◽  
Alejandro Egea-Zorrilla ◽  
Rosaura Leis ◽  
Gloria Bueno ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Gut Microbiota ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Metagenomic Study

scholarly journals Term infant formula supplemented with milk-derived oligosaccharides shifts the gut microbiota closer to that of human milk-fed infants and improves intestinal immune defense: A randomized controlled trial

2021 ◽  
Author(s):  
Elvira Estorninos ◽  
Rachel B Lawenko ◽  
Eisel Palestroque ◽  
Norbert Sprenger ◽  
Jalil Benyacoub ◽  
...  
Keyword(s):  
Immune Response ◽  
Randomized Controlled Trial ◽  
Gut Microbiota ◽  
Human Milk ◽  
Infant Formula ◽  
Controlled Trial ◽  
Immune Defense ◽  
Intact Protein ◽  
Phylogenetic Distance ◽  
Randomized Controlled

Abstract Background Bovine milk-derived oligosaccharides (MOS) containing primarily galacto-oligosaccharides with inherent levels of sialylated oligosaccharides can be added to infant formula to enhance the oligosaccharide profile. Objective To investigate the effects of a MOS-supplemented infant formula on gut microbiota and intestinal immunity. Methods In a double-blind, randomized, controlled trial, healthy-term formula-fed infants aged 21–26 days either received an intact protein cow's milk-based formula (control group, CG, n = 112) or the same formula containing 7.2 g MOS/L (experimental group, EG, n = 114) until age 6 months. Exclusively human milk-fed infants (HFI, n = 70) from an observational study served as reference. Fecal samples collected at baseline, 2.5 and 4 months of age were assessed for microbiota (16S ribosomal ribonucleic acid—based approaches), metabolites and biomarkers of gut health and immune response. Results At age 2.5 and 4 months, redundancy analysis (P = 0.002) and average phylogenetic distance (P < 0.05) showed that the overall microbiota composition in EG was different from CG and closer to that of HFI. Similarly, EG caesarean-born infants were different from CG caesarean- or vaginally-born infants and approaching HFI vaginally-born infants. Relative bifidobacteria abundance was higher in EG vs. CG (P < 0.05) approaching HFI. At age 4 months, counts of Clostridioides difficile and Clostridium perfringens were ∼90% (P < 0.001) and ∼65% (P < 0.01) lower in EG vs. CG, respectively. Mean (95%CI) fecal secretory immunoglobulin A (IgA) in EG was twice that of CG [70 (57,85) vs. 34 (28,42) mg/g, P < 0.001] and closer to HFI. Fecal oral polio vaccine-specific IgA was ∼50% higher in EG vs. CG (P = 0.065). Compared to CG, EG and HFI had lower fecal calcium excretion (by ∼30%) and fecal pH (P < 0.001), and higher lactate concentration (P < 0.001). Conclusions Infant formula with MOS shifts the gut microbiota and metabolic signature closer to that of HFI, has a strong bifidogenic effect, reduces fecal pathogens, and improves intestinal immune response.

scholarly journals Effect of Vitamin A-Fortified Rice on the Gut Microbiota of Thai Lactating Women and Their Exclusively Breastfed Infants

2021 ◽  
Vol 20 (4) ◽  
Author(s):  
Lukman Azis ◽  
◽  
Siwaporn Pinkaew ◽  
Santad Wichienchot ◽  
◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Vitamin A ◽  
Gut Microbiota ◽  
Controlled Trial ◽  
Control Group ◽  
Lactating Women ◽  
Breastfed Infants ◽  
Randomized Controlled ◽  
Lactobacillus Spp ◽  
Clostridium Spp

Abstract The optimal vitamin A (VA) status of lactating women is important for mothers and their breastfed infants, especially in protecting against infectious diseases. Vitamin A fortified rice is one of the food-base intervention strategy which has the potential to improve VA status. Vitamin A and gut microbiota are interrelated in their effect on human health and immunity however no specific relationship has been proved in these groups of population. This study aimed to determine the effect of VA fortified rice on the gut microbiota changes of lactating woman-exclusively breastfed infant pairs. A double-blind, randomized controlled trial (RCT) of VA fortified rice was conducted in 70 lactating women-infants pairs for 14 weeks. Gut microbiota was measured using the fluorescent in situ hybridization (FISH) and next generation sequencing (NGS) technique. Based on the FISH technique, the numbers of Clostridium spp. /Enterobacter spp. were significantly lower (P < 0.05) in mothers fed VA-fortified rice at the end of the study. In contrast, the abundance of Bifidobacterium spp. and Lactobacillus spp. of infants whose mothers fed with VA-fortified rice was significantly higher (P < 0.05) than the control group. The NGS technique confirmed that results with the increasing of Lactobacillus, B. longum and B. Choerinum in the infant of intervention group. In conclusion, VA-fortified rice was efficacious in decreasing Clostridium spp. /Enterobacter spp. in lactating women and raising the number of Bifidobacterium spp. and Lactobacillus spp. in their breastfed infants. Keywords: Breastfeeding, Gut microbiota, Lactating woman-infant pairs, Randomized controlled trial, Vitamin A

scholarly journals An Almond-Based Low Carbohydrate Diet Improves Depression and Glycometabolism in Patients with Type 2 Diabetes through Modulating Gut Microbiota and GLP-1: A Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3036
Author(s):  
Mengxiao Ren ◽  
Huaiyu Zhang ◽  
Jindan Qi ◽  
Anni Hu ◽  
Qing Jiang ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Randomized Controlled Trial ◽  
Gut Microbiota ◽  
Controlled Trial ◽  
Glycosylated Hemoglobin ◽  
Depression Symptoms ◽  
Carbohydrate Diet ◽  
Low Carbohydrate Diet ◽  
Randomized Controlled

Background: Alow carbohydrate diet (LCD) is more beneficial for the glycometabolism in type 2 diabetes (T2DM) and may be effective in reducing depression. Almond, which is a common nut, has been shown to effectively improve hyperglycemia and depression symptoms. This study aimed to determine the effect of an almond-based LCD (a-LCD) on depression and glycometabolism, as well as gut microbiota and fasting glucagon-like peptide 1 (GLP-1) in patients with T2DM. Methods: This was a randomized controlled trial which compared an a-LCD with a low-fat diet (LFD). Forty-five participants with T2DM at a diabetes club and the Endocrine Division of the First and Second Affiliated Hospital of Soochow University between December 2018 to December 2019 completed each dietary intervention for 3 months, including 22 in the a-LCD group and 23 in the LFD group. The indicators for depression and biochemical indicators including glycosylated hemoglobin (HbA1c), gut microbiota, and GLP-1 concentration were assessed at the baseline and third month and compared between the two groups. Results: A-LCD significantly improved depression and HbA1c (p < 0.01). Meanwhile, a-LCD significantly increased the short chain fatty acid (SCFAs)-producing bacteria Roseburia, Ruminococcus and Eubacterium. The GLP-1 concentration in the a-LCD group was higher than that in the LFD group (p < 0.05). Conclusions: A-LCD could exert a beneficial effect on depression and glycometabolism in patients with T2DM. We speculate that the role of a-LCD in improving depression in patients with T2DM may be associated with it stimulating the growth of SCFAs-producing bacteria, increasing SCFAs production and GPR43 activation, and further maintaining GLP-1 secretion. In future studies, the SCFAs and GPR43 activation should be further examined.

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