scholarly journals Faecal microbiota transplantation alters gut microbiota in patients with irritable bowel syndrome: results from a randomised, double-blind placebo-controlled study

Gut ◽  
2018 ◽  
Vol 67 (12) ◽  
pp. 2107-2115 ◽  
Author(s):  
Sofie Ingdam Halkjær ◽  
Alice Højer Christensen ◽  
Bobby Zhao Sheng Lo ◽  
Patrick Denis Browne ◽  
Stig Günther ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Controlled Trial ◽  
Symptom Relief ◽  
Controlled Study ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Faecal Microbiota Transplantation ◽  
Faecal Samples ◽  
Significant Difference

ObjectiveIBS is associated with an intestinal dysbiosis and faecal microbiota transplantation (FMT) has been hypothesised to have a positive effect in patients with IBS. We performed a randomised, double-blind placebo-controlled trial to investigate if FMT resulted in an altered gut microbiota and improvement in clinical outcome in patients with IBS.DesignWe performed this study in 52 adult patients with moderate-to-severe IBS. At the screening visit, clinical history and symptoms were assessed and faecal samples were collected. Patients were randomised to FMT or placebo capsules for 12 days and followed for 6 months. Study visits were performed at baseline, 1, 3 and 6 months, where patients were asked to register their symptoms using the IBS-severity scoring system (IBS-SSS) and IBS-specific quality of life (IBS-QoL). Prior to each visit, faecal samples were collected.ResultsA significant difference in improvement in IBS-SSS score was observed 3 months after treatment (p=0.012) favouring placebo. This was similar for IBS-QoL data after 3 months (p=0.003) favouring placebo. Patients receiving FMT capsules had an increase in faecal microbial biodiversity while placebos did not.ConclusionIn this randomised double-blinded placebo-controlled study, we found that FMT changed gut microbiota in patients with IBS. But patients in the placebo group experienced greater symptom relief compared with the FMT group after 3 months. Altering the gut microbiota is not enough to obtain clinical improvement in IBS. However, different study designs and larger studies are required to examine the role of FMT in IBS.Trial registration numberNCT02788071.

scholarly journals Efficacy of faecal microbiota transplantation for patients with irritable bowel syndrome in a randomised, double-blind, placebo-controlled study

Gut ◽  
2019 ◽  
Vol 69 (5) ◽  
pp. 859-867 ◽  
Author(s):  
Magdy El-Salhy ◽  
Jan Gunnar Hatlebakk ◽  
Odd Helge Gilja ◽  
Anja Bråthen Kristoffersen ◽  
Trygve Hausken
Keyword(s):  
Irritable Bowel Syndrome ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Rrna Gene ◽  
Faecal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Faecal Microbiota Transplantation ◽  
Link Type ◽  
Irritable Bowel

ObjectiveFaecal microbiota transplantation (FMT) from healthy donors to patients with irritable bowel syndrome (IBS) has been attempted in two previous double-blind, placebo-controlled studies. While one of those studies found improvement of the IBS symptoms, the other found no effect. The present study was conducted to clarify these contradictory findings.DesignThis randomised, double-blind, placebo-controlled study randomised 165 patients with IBS to placebo (own faeces), 30 g FMT or 60 g FMT at a ratio of 1:1:1. The material for FMT was obtained from one healthy, well-characterised donor, frozen and administered via gastroscope. The primary outcome was a reduction in the IBS symptoms at 3 months after FMT (response). A response was defined as a decrease of 50 or more points in the total IBS symptom score. The secondary outcome was a reduction in the dysbiosis index (DI) and a change in the intestinal bacterial profile, analysed by 16S rRNA gene sequencing, at 1 month following FMT.ResultsResponses occurred in 23.6%, 76.9% (p<0.0001) and 89.1% (p<00.0001) of the patients who received placebo, 30 g FMT and 60 g FMT, respectively. These were accompanied by significant improvements in fatigue and the quality of life in patients who received FMT. The intestinal bacterial profiles changed also significantly in the groups received FMT. The FMT adverse events were mild self-limiting gastrointestinal symptoms.ConclusionsFMT is an effective treatment for patients with IBS. Utilising a well-defined donor with a normal DI and favourable specific microbial signature is essential for successful FMT. The response to FMT increases with the dose.Trial registrationwww.clinicaltrials.gov (NCT03822299) and www.cristin.no (ID657402).

scholarly journals Effect of Recombinant Human Parathyroid Hormone (1-84) on Resolution of Active Charcot Neuro-osteoarthropathy in Diabetes: A Randomized, Double-Blind, Placebo-Controlled Study

2021 ◽  
Author(s):  
Nina L Petrova ◽  
Nicholas K. Donaldson ◽  
Maureen Bates ◽  
Wegin Tang ◽  
Timothy Jemmott ◽  
...  
Keyword(s):  
Parathyroid Hormone ◽  
Controlled Trial ◽  
Linear Regression Analysis ◽  
Controlled Study ◽  
X Rays ◽  
Human Parathyroid Hormone ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Prolonged Immobilization

<b>Objectives</b>: Fractures in Charcot neuro-osteoarthropathy (CN) often fail to heal despite prolonged immobilization with below-knee casting. The aim of the study was to assess the efficacy of recombinant human parathyroid hormone (PTH) in reducing time to resolution of CN and healing of fractures. <p><b>Research Design and Methods</b>: People with diabetes and acute (active) Charcot foot were randomized (double-blind) to either full length PTH (1-84) or placebo therapy - both in addition to below-knee casting and Calcium and Vitamin D3 supplementation. The primary outcome was resolution of CN, defined as a skin foot temperature difference below 2°C at two consecutive monthly visits. </p> <p><b>Results:</b> Median time to resolution was 5 months (95% CI 4, 12) in intervention and 6 months (95% CI 2, 9) in control. There was no significant difference in time to resolution between the groups (mixed effects logistic regression; p=0.64). The hazard ratio of resolution was 0.84 (95% CI 0.41, 1.74), p=0.64 and the odds ratio of resolution by 12 months was 1.22 (0.90, 1.67), p=0.20 (intervention versus control). On linear regression analysis, there were no significant differences in the effect of treatment on fracture scores quantitated on magnetic resonance imaging <a>scans </a>(coef= 0.13; 95% CI -0.62, 0.88; p=0.73) and on foot and ankle X-rays (coef= 0.30; 95% CI -0.03, 0.63; p=0.07). </p> <p><b>Conclusions</b>: This double-blind placebo-controlled trial did not reduce time to resolution or enhance fracture healing of CN. There was no added benefit of daily intervention with PTH (1-84) to below-knee casting in achieving earlier resolution of CN. </p>

scholarly journals Effect of Recombinant Human Parathyroid Hormone (1-84) on Resolution of Active Charcot Neuro-osteoarthropathy in Diabetes: A Randomized, Double-Blind, Placebo-Controlled Study

2021 ◽  
Author(s):  
Nina L Petrova ◽  
Nicholas K. Donaldson ◽  
Maureen Bates ◽  
Wegin Tang ◽  
Timothy Jemmott ◽  
...  
Keyword(s):  
Parathyroid Hormone ◽  
Controlled Trial ◽  
Linear Regression Analysis ◽  
Controlled Study ◽  
X Rays ◽  
Human Parathyroid Hormone ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference ◽  
Prolonged Immobilization

<b>Objectives</b>: Fractures in Charcot neuro-osteoarthropathy (CN) often fail to heal despite prolonged immobilization with below-knee casting. The aim of the study was to assess the efficacy of recombinant human parathyroid hormone (PTH) in reducing time to resolution of CN and healing of fractures. <p><b>Research Design and Methods</b>: People with diabetes and acute (active) Charcot foot were randomized (double-blind) to either full length PTH (1-84) or placebo therapy - both in addition to below-knee casting and Calcium and Vitamin D3 supplementation. The primary outcome was resolution of CN, defined as a skin foot temperature difference below 2°C at two consecutive monthly visits. </p> <p><b>Results:</b> Median time to resolution was 5 months (95% CI 4, 12) in intervention and 6 months (95% CI 2, 9) in control. There was no significant difference in time to resolution between the groups (mixed effects logistic regression; p=0.64). The hazard ratio of resolution was 0.84 (95% CI 0.41, 1.74), p=0.64 and the odds ratio of resolution by 12 months was 1.22 (0.90, 1.67), p=0.20 (intervention versus control). On linear regression analysis, there were no significant differences in the effect of treatment on fracture scores quantitated on magnetic resonance imaging <a>scans </a>(coef= 0.13; 95% CI -0.62, 0.88; p=0.73) and on foot and ankle X-rays (coef= 0.30; 95% CI -0.03, 0.63; p=0.07). </p> <p><b>Conclusions</b>: This double-blind placebo-controlled trial did not reduce time to resolution or enhance fracture healing of CN. There was no added benefit of daily intervention with PTH (1-84) to below-knee casting in achieving earlier resolution of CN. </p>

The Use of Aromatherapy to Reduce Chemotherapy-Induced Nausea in Children With Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial

2018 ◽  
Vol 35 (6) ◽  
pp. 392-398 ◽  
Author(s):  
Anna Evans ◽  
Jemily Malvar ◽  
Cassie Garretson ◽  
Eliza Pedroja Kolovos ◽  
Mary Baron Nelson
Keyword(s):  
Essential Oil ◽  
Assessment Tool ◽  
Controlled Trial ◽  
Controlled Study ◽  
Children With Cancer ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Statistical Significant Difference ◽  
Significant Difference

Introduction: Chemotherapy-induced nausea can be distressing and difficult to manage in children with cancer. The purpose of this study was to investigate the utility of ginger aromatherapy in relieving chemotherapy-induced nausea in children with cancer. Method: This randomized, double-blind, placebo-controlled study of 49 children with cancer explored whether inhalation of the aroma of essential oil of ginger during chemotherapy decreased nausea compared with a placebo (water) or control (Johnson’s baby shampoo) measured by prechemotherapy and postchemotherapy assessment with the Pediatric Nausea Assessment Tool (PeNAT). Results: While well received, well tolerated, nontoxic, and noninvasive, ginger aromatherapy did not significantly decrease nausea in patients enrolled in this study. Among 21 patients who indicated feeling nausea prechemotherapy, 67% reported improvement, 5% worsening, and 28% no change in their postinfusion PeNAT score. We failed to detect a statistical significant difference in the change in PeNAT scores among the three groups.

scholarly journals Traditional Chinese Herbal Patch for Short-Term Management of Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Xuezong Wang ◽  
Yuelong Cao ◽  
Jian Pang ◽  
Jiong Du ◽  
Chaoqing Guo ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Controlled Trial ◽  
Controlled Study ◽  
Short Term ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Chinese Herbal ◽  
Placebo Patch ◽  
Long Term Study ◽  
Significant Difference

Objective. To assess the short-term efficacy and safety of two kinds of Traditional Chinese herbal patches, Fufang Nanxing Zhitong Gao (FNZG) and Shangshi Jietong Gao (SJG), for painful knee osteoarthritis (OA).Methods. Patients were randomly enrolled in a double-blind, placebo-controlled study to receive FNZG (n=60), SJG (n=60), or placebo patch (n=30) for 7 days. Outcome measures included visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Traditional Chinese Medicine Syndrome Questionnaire (TCMSQ) subscale.Results. Although there was no significant difference among, three groups in short-term pain management, patients receiving FNZG got significant improvement in symptom of fear of coldness as compared with placebo patch (P=0.029). The most common local adverse events of rash, itching, erythema, and slightly damaged skin were observed in 7% of participants.Conclusions. FNZG may be a useful treatment for symptom of knee OA and merits long-term study in broader populations.

scholarly journals Involvement of N-methyl-d-aspartate receptors in plasticity induced by paired corticospinal-motoneuronal stimulation in humans

2018 ◽  
Vol 119 (2) ◽  
pp. 652-661 ◽  
Author(s):  
Siobhan C. Dongés ◽  
Jessica M. D’Amico ◽  
Jane E. Butler ◽  
Janet L. Taylor
Keyword(s):  
Biceps Brachii ◽  
Motor Evoked Potentials ◽  
Controlled Study ◽  
Spinal Level ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Human Spinal Cord ◽  
Significant Difference ◽  
Antidromic Potentials ◽  
Dependent Mechanism

Plasticity can be induced at human corticospinal-motoneuronal synapses by delivery of repeated, paired stimuli to corticospinal axons and motoneurons in a technique called paired corticospinal-motoneuronal stimulation (PCMS). To date, the mechanisms of the induced plasticity are unknown. To determine whether PCMS-induced plasticity is dependent on N-methyl-d-aspartate receptors (NMDARs), the effect of the noncompetitive NMDAR antagonist dextromethorphan on PCMS-induced facilitation was assessed in a 2-day, double-blind, placebo-controlled experiment. PCMS consisted of 100 pairs of stimuli, delivered at an interstimulus interval that produces facilitation at corticospinal-motoneuronal synapses that excite biceps brachii motoneurons. Transcranial magnetic stimulation elicited corticospinal volleys, which were timed to arrive at corticospinal-motoneuronal synapses just before antidromic potentials elicited in motoneurons with electrical brachial plexus stimulation. To measure changes in the corticospinal pathway at a spinal level, biceps responses to cervicomedullary stimulation (cervicomedullary motor evoked potentials, CMEPs) were measured before and for 30 min after PCMS. Individuals who displayed a ≥10% increase in CMEP size after PCMS on screening were eligible to take part in the 2-day experiment. After PCMS, there was a significant difference in CMEP area between placebo and dextromethorphan days ( P = 0.014). On the placebo day PCMS increased average CMEP areas to 127 ± 46% of baseline, whereas on the dextromethorphan day CMEP area was decreased to 86 ± 33% of baseline (mean ± SD; placebo: n = 11, dextromethorphan: n = 10). Therefore, dextromethorphan suppressed the facilitation of CMEPs after PCMS. This indicates that plasticity induced at synapses in the human spinal cord by PCMS may be dependent on NMDARs. NEW & NOTEWORTHY Paired corticospinal-motoneuronal stimulation can strengthen the synaptic connections between corticospinal axons and motoneurons at a spinal level in humans. The mechanism of the induced plasticity is unknown. In our 2-day, double-blind, placebo-controlled study we show that the N-methyl-d-aspartate receptor (NMDAR) antagonist dextromethorphan suppressed plasticity induced by paired corticospinal-motoneuronal stimulation, suggesting that an NMDAR-dependent mechanism is involved.

Sign in / Sign up

Export Citation Format

Share Document