scholarly journals The Usefulness of Microencapsulated Sodium Butyrate Add-On Therapy in Maintaining Remission in Patients with Ulcerative Colitis: A Prospective Observational Study

2020 ◽  
Vol 9 (12) ◽  
pp. 3941
Author(s):  
Marta Vernero ◽  
Federico De Blasio ◽  
Davide Giuseppe Ribaldone ◽  
Elisabetta Bugianesi ◽  
Rinaldo Pellicano ◽  
...  

Butyrate is a short-chain fatty acid that plays a key role in maintaining gut homeostasis as well as the integrity of the intestinal barrier. In the present study, we investigated the effect of oral microencapsulated sodium butyrate (BLM) administration in maintaining remission and improving residual symptoms and inflammatory markers in a population of patients with ulcerative colitis (UC). Forty-two patients with UC in clinical remission were enrolled in the study. Three patients were lost to follow up; 39 patients (18 treated with BLM add-on therapy and 21 with standard mesalamine only) that reached 12 months of follow up were included in the final analysis. Therapeutic success (defined as Mayo partial score ≤ 2 and faecal calprotectin (FC) < 250 µg/g at 12 months of follow up) was achieved in 25 patients (64.1%); 15/18 (83.3%) in BLM group and 10/21 (47.6%) in control group (p = 0.022). Consistently, 13/18 patients (72.2%) receiving BLM improved residual symptoms compared to 5/21 patients (23.8%) in control group (p = 0.003). FC values significantly diminished from the baseline to the end of follow up in patients that received BLM, while FC values remained almost stable in the control group. In conclusion, oral BLM supplementation appears to be a valid add-on therapy in order to maintain remission in patients with UC. Further randomized, placebo-controlled, double-blind clinical trials are needed to validate our results on a larger population or cohort of patients.

Author(s):  
Genaro Gabriel Ortiz ◽  
Luis Humberto De Loera Rodríguez ◽  
Paloma Rivero Moragrega ◽  
Irma Ernestina Velázquez Brizuela ◽  
Juan Francisco Santoscoy Gutiérrez ◽  
...  

Background: Patients with cervical cancer (CC) receiving chemotherapy and radiotherapy have several gastrointestinal adverse effects. Objective: To evaluate the effect of dietary symbiotic supplementation on fecal calprotectin, bacterial DNA levels, and gastrointestinal adverse effects in patients with CC. Methods: Clinical, controlled, randomized, double-blind trial. Patients consumed symbiotics or placebo three times a day for 7 weeks. Fecal calprotectin was assessed by Elisa method. DNA from probiotic and pathogenic bacteria were determined by quantitative real-time polymerase chain reaction. Diarrheal evacuations were evaluated with the Bristol scale and nausea and vomiting were measured using the scale of the National Institute of Cancerology of the United States. Results: Fecal calprotectin concentration was lower in the symbiotic group compared to the control group (p <0.001). The concentrations and total proportions of the probiotic and pathogenic bacteria were similar in both groups. Nausea cases significantly diminished in both groups (p <0.001) at the end of the trial. Furthermore, the symbiotic group had a statistically significant decrease in the frequency and intensity of vomiting when compared to the control group (p <0.001). Conclusions: The symbiotic treatment decreases significantly the fecal calprotectin levels and the frequency and intensity of vomiting in patients with CC. KEYWORDS: faecal calprotectin, cervical cancer, symbiotic, qPCR.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S063-S063
Author(s):  
E V Loftus ◽  
S W Schreiber ◽  
S Danese ◽  
L Peyrin-Biroulet ◽  
J F Colombel ◽  
...  

Abstract Background Patients with ulcerative colitis (UC) experience substantial impairment in quality of life (QOL). Patient QOL endpoints are important measures of treatment outcome. We evaluated the effects of intravenous vedolizumab vs. adalimumab on QOL in VARSITY, the first head-to-head trial comparing the efficacy and safety of biologics in patients with moderately to severely active UC. Methods VARSITY was a phase 3b, double-blind, double-dummy, randomised trial (NCT02497469; EudraCT 2015-000939-33). QOL was assessed using the inflammatory bowel disease questionnaire (IBDQ) at baseline, Week (Week) 30, and Week 52. Endpoints included clinically meaningful IBDQ improvement (defined as an increase in total score of ≥16 points from baseline to Week 52), IBDQ remission (defined as a total score of &gt;170 points at Week 52) and change from baseline in IBDQ-specific domain scores (bowel symptoms, systemic symptoms, emotional function, and social function) at Week 30 and Week 52. Serum C-reactive protein (CRP) and faecal calprotectin (FCP) were also assessed as indicators of disease activity. Results Among randomised patients, 383 (vedolizumab) and 386 (adalimumab) patients received ≥1 dose of study drug (N=769). At Week 52, clinically meaningful IBDQ improvement was observed in 52.0% (vedolizumab) vs. 42.2% (adalimumab) of patients (treatment difference 9.7%; 95% confidence interval [CI], 2.7% to 16.7%), while IBDQ remission was achieved by 50.1% (vedolizumab) vs. 40.4% (adalimumab) of patients (treatment difference 9.6%; 95% CI, 2.8% to 16.5%). Mean (standard deviation [SD]) changes in IBDQ total score from baseline for observed cases favoured vedolizumab over adalimumab (Week 30: 61.3 [39.8] vs. 52.6 [42.8]; Week 52: 66.1 [41.8] vs. 60.4 [42.2]; Figure 1). IBDQ subscores showed similar favourable trends for vedolizumab (Figure 2). At Week 52, mean (SD) changes from baseline in CRP for patients treated with vedolizumab vs. adalimumab were –50.9 (174.8) nmol/l vs. –37.2 (169.2) nmol/l and for FCP were –2187.3 (7440.4) µg/g vs. –1846.6 (4560.6) µg/g (Figure 3). Among patients with FCP &gt;250 µg/g at baseline, the proportion of patients achieving FCP ≤250 µg/g was 33.9% vs. 24.5% at Week 30 and 35.2% vs. 28.9% at Week 52 for patients treated with vedolizumab vs. adalimumab, respectively. Conclusion Based on IBDQ total score and subscores, more patients with UC treated with vedolizumab than with adalimumab achieved clinically meaningful improvement and clinical remission. Reduced inflammation, as indicated by improvements in CRP and FCP, was consistent with improvements in QOL.


2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S474-S474
Author(s):  
C Arieira ◽  
F Dias de Castro ◽  
T Cúrdia Gonçalves ◽  
M J Moreira ◽  
J Cotter

Abstract Background Biologic therapy has demonstrated efficacy for induction and maintenance of remission in ulcerative colitis (UC). However, it remains unclear whether oral aminosalicylates (5-ASA) should be continued or stopped after treatment escalation to biologics. The aim of the study was to evaluate differences in inflammatory biomarkers or the occurrence of complications in UC patients being treated with a combination of 5-ASA and biologics vs. biologics alone. Methods Retrospective study, including patients with UC and on biologic therapy with a minimum follow-up of 6 months. Collected inflammatory biomarkers were faecal calprotectin, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). The occurrence of complications was defined as the need of hospitalisation, need of corticosteroids or other top-up therapy, surgery and the occurrence of dysplasia or colorectal cancer. Results We included 65 patients with UC, 56.9% female with a mean age of 32.8 (±12.8) years. The median follow-up was 30 (6–132) months. Regarding extension, 61.5% were E3, 35.4% E2 and 3.1% E1. While 44 patients (67.7%) were on 5-ASA and biologics (infliximab = 32, adalimumab = 6, vedolizumab = 6), 21 (32.3%) were on biologics alone (infliximab = 13, adalimumab = 3, vedolizumab = 5). The median duration of biologic therapy was 30 (6–126) months. Regarding baseline characteristics, including age, gender, duration of the disease or biologic therapy and age at UC diagnosis, there were no differences between groups. No differences regarding inflammatory biomarkers were observed – fecal calprotectin (p = 0.39), CRP (p = 0.9) and ESR (p = 0.61). No differences were found regarding complications, namely the need of hospitalisation (p = 0.06) or need of corticosteroids (p = 0.89). Only one patient developed dysplasia (under infliximab and 5-ASA). Any of the included patients needed surgery or developed colorectal cancer. Conclusion About two-thirds of the UC patients under biologics are co-treated with 5-ASA. No differences between UC patients under combination biologics+5-ASA vs. biologics alone were found regarding inflammatory biomarkers or the occurrence of complications. These results raise the question if continuing 5-ASA in UC patients under biologics is really necessary.


2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S13-S13
Author(s):  
Chen Sarbagili-Shabat ◽  
Dror Weiner ◽  
Joram Wardi ◽  
Lee Abramas ◽  
Michal Yaakov ◽  
...  

Abstract Background Pediatric ulcerative colitis (UC) is characterized by low sustained remission rates and frequent extension of disease even if clinical remission is obtained with therapy. Moderate to severe endoscopic activity is a risk factor for relapse while evidence regarding early mucosal healing or persistence of inflammation after remission in children is not available. Our aim was to evaluate if persistence of significant inflammation is common and could explain the high relapse rate in pediatric UC. Methods Pediatric UC patients with clinical remission, defined as pediatric UC activity index (PUCAI) scores &lt; 10, were prospectively assessed for mucosal healing by endoscopy 3–5 months after remission was documented. Mayo score was assessed for each segment by a blinded adult gastroenterologist using central reading. Symptomatic patients prior to sigmoidoscopy were excluded Sustained remission was assessed retrospectively at 18 months follow-up. Results Forty-six children were enrolled, 28 children in continuous clinical remission at time of sigmoidoscopy were included in the final analysis. Mayo 0 was present in 12/28 (42.86%), Mayo 1 in 2/28 (7.1%) and Mayo 2–3 in 14/28 (50.0%) endoscopies. Among 23/28 patients with follow-up through 18 months, remission was sustained in 2/11 (18.18%) of patients with Mayo 2 and 3 versus 6/12 (50.0%) with Mayo score 0–1. Conclusion Over 50% of children assessed for mucosal healing 3–5 months after clinical remission is obtained have residual disease activity, primarily moderate to severe inflammation which was associated with lower sustained remission. Early sigmoidoscopy after clinical remission for assessment of mucosal disease should be considered in pediatric UC.


2021 ◽  
Author(s):  
Pamela Pindi ◽  
Josselin Houenou ◽  
Camille Piguet ◽  
Pauline Favre

Background: Neurofeedback using real-time functional MRI (RT-fMRI-NF) is an innovative technique that allows to voluntarily modulating a targeted brain response and its associated behavior. Despite promising results in the current literature, its effectiveness on symptoms’ management in psychiatric disorders is not yet clearly demonstrated. This review aims to evaluate the effectiveness of RT-fMRI-NF in the treatment of psychiatric disorders and to provide methodological suggestions for future studies. Methods: Web of Science and PubMed databases were searched using the keywords: neurofeedback AND (fMRI OR “functional magnetic resonance imag*” OR “functional MRI”) AND (“real-time” OR “real time”). Twenty-six clinical trials focusing on psychiatric disorders were included and categorized according to the diagnostic categories. The RT-fMRI-NF efficacy was assessed by reporting changes in clinical endpoints before vs. after NF training and before or after NF training vs. follow-up. Results: Among the 26 studies, 18 were controlled trials, of which five showed significant clinical improvement in the experimental vs. control group after the training. Eight studies found an effect at follow-up on ADHD symptoms, emotion dysregulation, depressive symptoms, hallucinations, psychotic symptoms and specific fear. Limitations: Here, we only focused our review on fMRI-based NF training. Conclusion: The use of RT-fMRI-NF as a treatment for psychiatric symptoms is promising. However, further double blind, randomized-controlled trials are warranted.


2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513


2019 ◽  
Vol 37 (8_suppl) ◽  
pp. 1-1 ◽  
Author(s):  
Annelies Hickerson ◽  
G. Travis Clifton ◽  
Diane F. Hale ◽  
Kaitlin M. Peace ◽  
Jarrod P. Holmes ◽  
...  

1 Background: Preclinical data shows synergism between trastuzumab (Tz) and HER2-targeted vaccines. We evaluated adjvuant nelipepimut-S (NPS) + GM-CSF with Tz compared to Tz with GM-CSF alone in HER2 low-expressing (LE) breast cancer (BC) patients (pts) to prevent recurrences. After a planned interim analysis showed benefit in triple negative BC (TNBC) pts, the decision was made to close the trial with guidance from the independent DSMB. Here, we report the final analysis of the trial with 7 months (mo) of added follow-up (f/u). Methods: The phase 2b trial enrolled clinically disease-free BC pts after standard therapy. Pts were HLA-A2, A3, A24, and/or A26+, had HER2-LE (IHC 1-2+, FISH non-amplified) BC and were node positive and/or TNBC. Pts were randomized to placebo with GM-CSF(control group, CG) or NPS with GM-CSF (vaccine group, VG), while all received Tz Q3wk for 1 year. GM-CSF or NPS + GM-CSF were given q3wks x 6 starting with the 3rd Tz dose, and boosters every 6 months x 4. Safety was assessed and pts were followed clinically for recurrences. The primary outcome was DFS at 24 mo. Results: 589 pts were screened at 26 sites. 275 pts were enrolled and randomized (VG:136, CG:139). There were no clinicopathologic differences between groups. Concurrent Tz and NPS was safe with no added overall or cardiac toxicity compared to CG and no grade 4/5 toxicities. In the ITT analysis (median f/u 25.7 mo), the estimated DFS was favorable but did not reach significance in the VG compared with the CG (HR 0.62, 95% CI: 0.31-1.25, p = 0.18). In the TNBC pts, the VG had statistically improved DFS compared to the CG (HR 0.26, 95% CI: 0.08-0.81, p = 0.013). Conclusions: The combination of NPS with Tz is safe with no added toxicity compared to Tz alone, even after prolonged exposure (25.7 mo). In this final analysis, there was a trend towards benefit in the ITT population that improved since the interim analysis with added f/u. The significant benefit seen at interim in the TNBC pts continued to strengthen in the VG group. These findings could position the NPS + Tz combination as an adjuvant therapy for early-stage TNBC and warrant further study. Clinical trial information: NCT01570036.


2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Yanhong Jessika Hu ◽  
Xudong Zhou ◽  
Shanjuan Wang ◽  
Merlin Willcox ◽  
Colin Garner ◽  
...  

Abstract Background Although rarely indicated, antibiotics are commonly used for acute diarrhoea in China. We conducted a randomised, double blind exploratory clinical trial of loperamide, berberine and turmeric for treatment of acute diarrhoea. Methods Adults with acute uncomplicated diarrhoea aged 18 to 70 were randomised to 4 groups: (A) loperamide; (B) loperamide and berberine; (C) loperamide and turmeric; (D) loperamide, berberine and turmeric. All participants were given rescue ciprofloxacin for use after 48 h if symptoms worsened or were unimproved. Primary endpoints were feasibility and ciprofloxacin use during the 2-week follow-up period. Semi-structured interviews were conducted following recruitment and were analysed thematically. Recruiting doctors, delivery pharmacists and research assistants were blinded to treatment allocation. Results Only 21.5% (278/1295) of patients screened were deemed eligible, and 49% (136/278) of these consented and were entered into the final analysis. Most participants had mild symptoms, because most patients with moderate or severe symptoms wanted to be given antibiotics. Follow-up was good (94% at 2 weeks). Only three participants used rescue antibiotics compared to 67% of acute diarrhoea patients in the hospital during the recruitment period. The median symptom duration was 14 h in group B (interquartile range (IQR) 10-22), 16 h in group D (IQR 10-22), 18 h in group A (IQR 10-33) and 20 h in group C (IQR 16-54). Re-consultation rates were low. There were no serious treatment-related adverse events. Most interviewed participants said that although they had believed antibiotics to be effective for diarrhoea, they were surprised by their quick recovery without antibiotics in this trial. Conclusion Although recruitment was challenging because of widespread expectations for antibiotics, patients with mild diarrhoea accepted trying an alternative. The three nutraceuticals therapy require further evaluation in a fully powered, randomised controlled trial among a broader sample. Trial registration ChiCTR-IPR-17014107


1998 ◽  
Vol 23 (1) ◽  
pp. 136-139 ◽  
Author(s):  
O. BASSO ◽  
J. M. PIKE

Thirty-eight patients with dorsally-displaced distal radial fractures were prospectively studied to assess the clinical effects of low frequency ultrasound treatment, started immediately after plaster removal. Nineteen of the patients represented the control group and a double-blind protocol was followed. Assessment took place on the day of plaster removal and 2 and 8 weeks later. There was no significant difference in wrist motion and duration of follow-up between the treated and control patients.


2019 ◽  
Vol 11 ◽  
pp. 1759720X1986913 ◽  
Author(s):  
Venta Donec ◽  
Raimondas Kubilius

Background: Kinesio Taping® method is a nonpharmacological alternative for pain management in musculoskeletal disorders. However, the existing evidence is insufficient to assess its full effectiveness for pain management in knee osteoarthritis (KO). Our aim was to evaluate the effectiveness of the Kinesio Taping method in reducing knee pain for KO patients. Methods: In this randomized, double blind, controlled trial, we recruited 187 patients with grade I-III KO who were allocated to either the Kinesio Taping or control group. The study was carried out in outpatient facility. Either Kinesio Taping or nonspecific taping was applied on the affected knee area for 4 weeks. Pain evaluation was performed at baseline, after 1 month of taping and after 1 further month without taping. The data on usage of painkillers were collected; Numeric Pain Rating Scale; an algometer, and Knee injury and Osteoarthritis Outcome Scores (KOOS) pain subscale were used to assess pain. Tolerance and subjective opinions toward the effectiveness of taping were evaluated. The chosen level of significance was p < 0.05, ß ⩽ 0.2. Results: The majority (>70%) of both groups’ patients indicated that tapes reduced the knee pain. The reported use of painkillers decreased, in addition to self-reported increase in the KOOS subscale, thereby indicating pain alleviation. All self-reported improvement remained at the 1-month follow up ( p < 0.05). Significantly higher and clinically meaningful reduction of pain intensity was found in the Kinesio Taping group after the treatment month, in comparison with the control group ( p < 0.05). More pain reduction was reported in the daytime for participants in the Kinesio Taping group at the follow up ( p = 0.022). No changes in algometry results were observed. Conclusions: Elastic taping can safely relieve knee pain and reduce the need for pharmacological management in KO. A specific Kinesio Taping technique is clinically more beneficial for knee-pain alleviation in comparison with nonspecific taping. [ ClinicalTrials.gov identifier: NCT03076177.]


Sign in / Sign up

Export Citation Format

Share Document