scholarly journals Probing Gut-Brain Links in Alzheimer's Disease with Rifaximin

2021 ◽  
Author(s):  
Paul V Suhocki ◽  
James S Ronald ◽  
Anna Mae E Diehl ◽  
David M Murdoch ◽  
P Murali Doraiswamy
Keyword(s):  
Pilot Trial ◽  
Controlled Clinical Trial ◽  
Serum Cytokine ◽  
Gut Flora ◽  
Open Label ◽  
Neurofilament Light ◽  
Neurodegenerative Process ◽  
Light Levels ◽  
Significant Downward Trend ◽  
Open Label Trial

Gut-microbiome-inflammation interactions have been linked to neurodegeneration in Alzheimers disease (AD) and other disorders. We hypothesized that treatment with rifaximin, a minimally absorbed gut-specific antibiotic, may modify the neurodegenerative process by changing gut flora and reducing neurotoxic microbial drivers of inflammation. In a pilot, open-label trial, we treated 10 subjects with mild to moderate probable AD dementia (MMSE = 17 + 3) with rifaximin for 3 months. Treatment was associated with a significant reduction in serum neurofilament-light levels (p <0.004) and a significant increase in fecal phylum Firmicutes microbiota. Serum pTau181 and GFAP levels were reduced (effect sizes of -0.41 and -0.48 respectively) but did not reach significance. There was also a non-significant downward trend in serum cytokine IL-6 and IL-13 levels. Increases in stool Erysipelatoclostridium were correlated significantly with reductions in serum pTau 181 and serum GFAP. Insights from this pilot trial are being used to design a larger placebo-controlled clinical trial to determine if specific microbial flora/products underlie neurodegeneration, and whether rifaximin is clinically efficacious as a therapeutic.

Methods of blinding clinical trials in physiotherapy

Physiotherapy ◽  
2013 ◽  
Vol 21 (1) ◽  
Author(s):  
Józef Opara ◽  
Cezary Kucio ◽  
Andrzej Małecki ◽  
Jan Pilch
Keyword(s):  
Clinical Trials ◽  
Physical Therapy ◽  
Medical Technology ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Double Blind ◽  
Subjective Expectations ◽  
Open Label Trial ◽  
Randomised Controlled ◽  
Single Blind

AbstractBlinding of scientific clinical trials prevents the influence of subjective expectations of the participants on the results. It is done by ensuring their lack of knowledge whether they are administered a given medical technology or not. Blinding a randomised controlled clinical trial in physiotherapy is difficult, and sometimes impossible, in particular where the patient is aware of the procedure and experiences certain sensations during it, as in electrotherapy. Researchers were met halfway by the equipment manufacturers for physical therapy. Already there are magnetostimulation devices with a “placebo” setting being produces, and yellow light-bulbs to install in pilerotherapy lamps. Sham ultrasound can be used as placebo (by placing the transducer against the skin without turning on the device). Both in physical therapy and kinesiotherapy, it is possible to single-blind the trial - when one person performs the procedure, and someone else evaluates its results. It is advisable that the evaluator should not belong to the team performing treatment and therefore not know whether the patient received the intervention or placebo. Where it is impossible to either single- or double-blind the trial, an open-label trial may be employed. In this demonstrative-review article, the present-day capabilities of blinding clinical data in physiotherapy.

Role of GERD in chronic resistant sinusitis (CRS): Results of a prospective, open-label pilot trial

2001 ◽  
Vol 120 (5) ◽  
pp. A425-A425
Author(s):  
B OLUSOLA ◽  
J DIBAISE ◽  
J HUERTER ◽  
E QUIGLEY
Keyword(s):  
Pilot Trial ◽  
Open Label

Llaser ablation vs radiofrequency ablation for benign non-functioning thyroid nodules: six-month results of a randomised, parallel, open-label, trial (LARA trial)

2020 ◽  
Author(s):  
Roberto Cesareo ◽  
Pacella Claudio Maurizio ◽  
Valerio Pasqualini ◽  
Giuseppe Campagna ◽  
Pantano Angelo Lauria ◽  
...  
Keyword(s):  
Radiofrequency Ablation ◽  
Thyroid Nodules ◽  
Open Label ◽  
Open Label Trial

Daily consumption of fermented soymilk helps to improve facial wrinkles in healthy postmenopausal women in a randomized, parallel-group, open-label trial

2018 ◽  
Vol 8 (2) ◽  
pp. 107 ◽  
Author(s):  
Mitsuyoshi Kano ◽  
Kazuyoshi Haga ◽  
Kouji Miyazaki ◽  
Fumiyasu Ishikawa
Keyword(s):  
Postmenopausal Women ◽  
Maximum Depth ◽  
Liquid Chromatography Mass Spectrometry ◽  
Daily Consumption ◽  
Open Label ◽  
Facial Wrinkle ◽  
Crow’S Feet ◽  
Parallel Group ◽  
Secondary Endpoints ◽  
Open Label Trial

Background: Soymilk fermented by lactobacilli and/or bifidobacteria is attracting attention due to the excellent bioavailability of its isoflavones. We investigated the effects of fermented soymilk containing high amounts of isoflavone aglycones on facial wrinkles and urinary isoflavones in postmenopausal women in a randomized, parallel-group, open-label trial. Healthy Japanese women were randomly divided into active (n = 44, mean age 56.3 ± 0.5) or control (n = 44, mean age 56.1 ± 0.5) groups, who consumed or did not consume a bottle of soymilk fermented by Bifidobacterium breve strain Yakult and Lactobacillus mali for 8 weeks. Maximum depth of wrinkles around the crow’s feet area and other wrinkle parameters were evaluated as primary and secondary endpoints respectively at weeks 0, 4, and 8 during the consumption period. Urinary isoflavone levels were determined by liquid chromatography-mass spectrometry. Results: The active group demonstrated significant improvements in the maximum depth (p=0.015) and average depth (p=0.04) of wrinkles, and significantly elevated urinary isoflavones (daidzein, genistein, and glycitein; each p < 0.001) compared with the control during the consumption period. No serious adverse effects were recorded.Conclusion: These findings suggest that fermented soymilk taken daily may improve facial wrinkles and elevate urinary isoflavones in healthy postmenopausal women.Key words: postmenopausal women; isoflavone; fermented soymilk; phytoestrogen; facial wrinkle 

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