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Plasma free amino acid profile in quiescent Inflammatory Bowel Disease patients orally administered with Mastiha (Pistacia lentiscus); a randomised clinical trial.
Papada, E, Amerikanou, C, Torović, L, Kalogeropoulos, N, Tzavara, C, Forbes, A, Kaliora, AC
Phytomedicine : international journal of phytotherapy and phytopharmacology. 2019;:40-47
Abstract
BACKGROUND Natural products have been studied regarding their effectiveness on Inflammatory Bowel Disease (IBD). HYPOTHESIS/PURPOSE To examine the effects of Mastiha (Pistacia lentiscus var. Chia) on clinical course and amino acid (AA) profile of patients in remission. STUDY DESIGN This is a randomised, double-blind, placebo-controlled clinical trial. METHODS Patients (n = 68) were randomly allocated to Mastiha (2.8 g/day) or placebo adjunct to stable medication. Free AAs were identified applying Gas Chromatography-Mass Spectrometry in plasma. Medical-dietary history, Inflammatory Bowel Disease Questionnaire, Harvey-Bradshaw Index, Partial Mayo Score, biochemical, faecal and blood inflammatory markers were assessed. Primary endpoint was the clinical relapse rate at 6 months. Secondary endpoints included variations in free AAs, inflammatory biomarkers and quality of life. Statistical significance was set at 0.05. RESULTS Concerning AAs and biochemical data, alanine (p = 0.006), valine (p = 0.047), proline (p = 0.022), glutamine (p < 0.001) and tyrosine (p = 0.043) along with total cholesterol (p = 0.032) and LDL cholesterol (p = 0.045) increased only in placebo group compared with baseline and the change between the study groups was significantly different. Inflammatory markers had not a significantly different change between the two groups, even serum IL-6, faecal calprotectin and faecal lactoferrin increased only in the placebo group. Although Mastiha was not proven superior to placebo in remission rate (17.6% vs. 23.5%, p = 0.549), attenuation in increase of free AAs levels in verum group is reported. CONCLUSION Mastiha inhibited an increase in plasma free AAs seen in patients with quiescent IBD. Since change of AAs is considered an early prognostic marker of disease activity, this indicates a potential role of Mastiha in remission maintenance.
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Regulation of faecal biomarkers in inflammatory bowel disease patients treated with oral mastiha (Pistacia lentiscus) supplement: A double-blind and placebo-controlled randomised trial.
Papada, E, Gioxari, A, Amerikanou, C, Forbes, A, Tzavara, C, Smyrnioudis, I, Kaliora, AC
Phytotherapy research : PTR. 2019;(2):360-369
Abstract
There is a keen research upon the effects of nutraceuticals on inflammatory bowel disease. The purpose of this study was to explore the effect of mastiha supplement, rich in bioactive nutraceuticals, in active inflammatory bowel disease. This is a randomised, double-blind, placebo-controlled clinical trial. Α total of 60 inflammatory bowel disease patients were enrolled and randomly allocated to mastiha (2.8 g/day) or placebo groups for 3 months adjunct to stable medical treatment. Medical and dietary history, Inflammatory Bowel Disease Questionnaire (IBDQ), Harvey-Bradshaw index, partial Mayo score, biochemical indices, faecal, and blood inflammatory markers were assessed. A clinically important difference between groups in IBDQ was defined as primary outcome. Inflammatory Bowel Disease Questionnaire score significantly improved in verum compared with baseline (p = 0.004). There was a significant decrease in faecal lysozyme in mastiha patients (p = 0.018) with the mean change being significant (p = 0.021), and significant increases of faecal lactoferrin (p = 0.001) and calprotectin (p = 0.029) in the placebo group. Fibrinogen reduced significantly (p = 0.006) with a significant mean change (p = 0.018), whereas iron increased (p = 0.032) in mastiha arm. Our results show regulation of faecal lysozyme by mastiha supplement adjunctive to pharmacological treatments in active inflammatory bowel disease. An effect secondary to a prebiotic potency is proposed.
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Randomized Trial of Vitamin D Supplementation to Prevent Seasonal Influenza and Upper Respiratory Infection in Patients With Inflammatory Bowel Disease.
Arihiro, S, Nakashima, A, Matsuoka, M, Suto, S, Uchiyama, K, Kato, T, Mitobe, J, Komoike, N, Itagaki, M, Miyakawa, Y, et al
Inflammatory bowel diseases. 2019;(6):1088-1095
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Abstract
BACKGROUND We evaluated whether oral vitamin D supplementation during the winter and early spring reduces the incidence of influenza and upper respiratory infections in patients with inflammatory bowel disease (IBD). METHODS A randomized, double-blind, controlled trial was conducted to compare the effects of vitamin D supplementation (500 IU/day) and a placebo. The primary outcome was the incidence of influenza; the secondary outcome was the incidence of upper respiratory infection. Prespecified subgroup analyses were performed according to 25-hydroxyvitamin D (25-OHD) levels (low <20 ng/mL or high ≥20 ng/mL) and whether ulcerative colitis (UC) or Crohn's disease (CD) was present. We also used the Lichtiger clinical activity index for patients with UC and the Crohn's Disease Activity Index (CDAI) for patients with CD before and after interventions. RESULTS We included 223 patients with IBD and randomized them into 2 groups: vitamin D supplementation (n = 108) and placebo (n = 115). The incidence of influenza did not differ between the groups. However, the incidence of upper respiratory infection was significantly lower in the vitamin D group (relative risk [RR], 0.59; 95% confidence interval (CI), 0.35-0.98; P = 0.042). This effect was enhanced in the low 25-OHD level subgroup (RR, 0.36; 95% CI, 0.14-0.90; P = 0.02). With respect to adverse events, the Lichtiger clinical activity index score was significantly worse in the vitamin D group (P = 0.002) and remained significant only in the high 25-OHD level subgroup. CONCLUSIONS Vitamin D supplementation may have a preventative effect against upper respiratory infection in patients with IBD but may worsen the symptoms of UC.
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Efficacy of Home Telemonitoring versus Conventional Follow-up: A Randomized Controlled Trial among Teenagers with Inflammatory Bowel Disease.
Heida, A, Dijkstra, A, Muller Kobold, A, Rossen, JW, Kindermann, A, Kokke, F, de Meij, T, Norbruis, O, Weersma, RK, Wessels, M, et al
Journal of Crohn's & colitis. 2018;(4):432-441
Abstract
BACKGROUND AND AIMS Conventional follow-up of teenagers with inflammatory bowel diseases [IBD] is done during scheduled outpatient visits regardless of how well the patient feels. We designed a telemonitoring strategy for early recognition of flares and compared its efficacy with conventional follow-up. METHODS We used a multicentre randomized trial in patients aged 10-19 years with IBD in clinical remission at baseline. Participants assigned to telemonitoring received automated alerts to complete a symptom score and send a stool sample for measurement of calprotectin. This resulted in an individual prediction for flare with associated treatment advice and test interval. In conventional follow-up the health check interval was left to the physician's discretion. The primary endpoint was cumulative incidence of disease flares. Secondary endpoints were percentage of participants with a positive change in quality-of-life and cost-effectiveness of the intervention. RESULTS We included 170 participants [84 telemonitoring; 86 conventional follow-up]. At 52 weeks the mean number of face-to-face visits was significantly lower in the telemonitoring group compared to conventional follow-up [3.6 vs 4.3, p < 0.001]. The incidence of flares [33 vs 34%, p = 0.93] and the proportion of participants reporting positive change in quality-of-life [54 vs 44%, p = 0.27] were similar. Mean annual cost-saving was €89 and increased to €360 in those compliant to the protocol. CONCLUSIONS Telemonitoring is as safe as conventional follow-up, and reduces outpatient visits and societal costs. The positive impact on quality-of-life was similar in the two groups. This strategy is attractive for teenagers and families, and health professionals may be interested in using it to keep teenagers who are well out of hospital and ease pressure on overstretched outpatient services. TRIAL REGISTRATION NTR3759 [Netherlands Trial Registry].
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Reliability and validity of the Beliefs About Medication Scale in pediatric inflammatory bowel disease.
Thomason, MM, Poulopoulos, N, Nguyen, E, Gumidyala, AP, Kahn, SA, Greenley, RN
Journal of child health care : for professionals working with children in the hospital and community. 2017;(3):253-262
Abstract
Low adherence is a pervasive issue among youth with inflammatory bowel diseases (IBD), yet our understanding of perceived adherence barriers is hampered by a lack of validated instruments. This study sought to address this by evaluating the reliability and predictive validity of the Beliefs About Medication Scale (BAMS) among youth with IBD. Seventy-six youth (ages 11-18) with IBD who were prescribed a daily oral IBD medication completed baseline ratings of perceived adherence barriers via the BAMS. Parents provided information about patient demographic and disease factors. Subjective medication adherence was assessed via the medication adherence measure. Objective medication adherence was assessed via Medication Event Monitoring System (MEMS) Track Caps. BAMS subscales demonstrated adequate internal consistency ( αs = .78-.90) and test-retest reliability ( rs = .64-.79). BAMS subscales reliably distinguished between adherent and low adherent groups, though intent to adhere (IA) was the only independent predictor of adherence status. The BAMS holds promise as a tool for assessing adherence barriers among adolescents with IBD. IA may be of particular value in identifying adolescents at risk for low adherence.
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Telemedicine for management of inflammatory bowel disease (myIBDcoach): a pragmatic, multicentre, randomised controlled trial.
de Jong, MJ, van der Meulen-de Jong, AE, Romberg-Camps, MJ, Becx, MC, Maljaars, JP, Cilissen, M, van Bodegraven, AA, Mahmmod, N, Markus, T, Hameeteman, WM, et al
Lancet (London, England). 2017;(10098):959-968
Abstract
BACKGROUND Tight and personalised control of inflammatory bowel disease in a traditional setting is challenging because of the disease complexity, high pressure on outpatient clinics, and rising incidence. We compared the effects of self-management with a telemedicine system, which was developed for all subtypes of inflammatory bowel disease, on health-care utilisation and patient-reported quality of care versus standard care. METHODS We did this pragmatic, randomised trial in two academic and two non-academic hospitals in the Netherlands. Outpatients aged 18-75 years with inflammatory bowel disease and without an ileoanal or ileorectal pouch anastomosis, who had internet access and Dutch proficiency, were randomly assigned (1:1) to care via a telemedicine system (myIBDcoach) that monitors and registers disease activity or standard care and followed up for 12 months. Randomisation was done with a computer-generated sequence and used the minimisation method. Participants, health-care providers, and staff who assessed outcome measures were not masked to treatment allocation. Primary outcomes were the number of outpatient visits and patient-reported quality of care (assessed by visual analogue scale score 0-10). Safety endpoints were the numbers of flares, corticosteroid courses, hospital admissions, emergency visits, and surgeries. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02173002. FINDINGS Between Sept 9, 2014, and May 18, 2015, 909 patients were randomly assigned to telemedicine (n=465) or standard care (n=444). At 12 months, the mean number of outpatient visits to the gastroenterologist or nurse was significantly lower in the telemedicine group (1·55 [SD 1·50]) than in the standard care group (2·34 [1·64]; difference -0·79 [95% CI -0·98 to -0·59]; p<0·0001), as was the mean number of hospital admissions (0·05 [0·28] vs 0·10 [0·43]; difference -0·05 [-0·10 to 0·00]; p=0·046). At 12 months, both groups reported high mean patient-reported quality of care scores (8·16 [1·37] in the telemedicine group vs 8·27 [1·28] in the standard care group; difference 0·10 [-0·13 to 0·32]; p=0·411). The mean numbers of flares, corticosteroid courses, emergency visits, and surgeries did not differ between groups. INTERPRETATION Telemedicine was safe and reduced outpatient visits and hospital admissions compared with standard care. This self-management tool might be useful for reorganising care of inflammatory bowel disease towards personalised and value-based health care. FUNDING Maastricht University Medical Centre and Ferring.
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Metronidazole or Rifaximin for Treatment of Clostridium difficile in Pediatric Patients with Inflammatory Bowel Disease: A Randomized Clinical Trial.
Gawronska, A, Banasiuk, M, Lachowicz, D, Pituch, H, Albrecht, P, Banaszkiewicz, A
Inflammatory bowel diseases. 2017;(12):2209-2214
Abstract
BACKGROUND Interestingly, Clostridium difficile infection (CDI) worsens the course of inflammatory bowel disease (IBD); however, there is a paucity of data regarding the treatment of CDI in this group of patients. METHODS This was a prospective, single-blind trial. Children with flare of IBD and CDI were randomly assigned to receive metronidazole or rifaximin orally for 14 days. CDI was diagnosed based on a positive well-type enzyme immunoassay (EIA) toxins A/B stool test for C. difficile toxins A and/or B. The cure rate was defined as the percentage of patients with a negative EIA stool test for C. difficile toxins A/B measured 4 weeks after the end of treatment. Recurrence was defined as a repeat CDI within 2 to 8 weeks. RESULTS In total, we included 31 patients with IBD including 12 patients with Crohn's disease and 19 with ulcerative colitis. Of them, 17 received metronidazole and 14 received rifaximin. There were no statistically significant differences between the 2 study groups including age, type of treatment, and disease activity. There was no statistically significant difference in the cure rate between patients treated with metronidazole and rifaximin (70.6% versus 78.6%, respectively, P = 0.5). We found no difference in recurrence rate between the 2 study treatment types (17% versus 0%, respectively, P = 0.3). We did not find an association between immunosuppressive therapy and CDI cure rate or CDI recurrence rate. CONCLUSIONS Metronidazole and rifaximin were similarly effective treatments for CDI in pediatric patients with IBD.
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Use of complementary and alternative medicine in Swedish patients with inflammatory bowel disease: a controlled study.
Oxelmark, L, Lindberg, A, Löfberg, R, Sternby, B, Eriksson, A, Almer, S, Befrits, R, Fossum, B, Karlén, P, Broström, O, et al
European journal of gastroenterology & hepatology. 2016;(11):1320-8
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BACKGROUND There is an increasing interest in complementary and alternative medicine (CAM) in patients with chronic diseases, including those with inflammatory bowel disease (IBD). Patients may turn to CAM when conventional therapies are inadequate or associated with side effects for symptomatic relief or to regain control over their disease. The objectives were to explore CAM use and perceived effects in IBD patients in comparison with a control group. METHODS A cross-sectional, multicenter, controlled study was carried out. IBD patients were invited from 12 IBD clinics in Sweden. Controls were selected randomly from a residence registry. A study-specific questionnaire was used for data collection. RESULTS Overall, 48.3% of patients with IBD had used some kind of CAM during the past year compared with 53.5% in controls (P=0.025, adjusted for age, sex, geographic residence, and diet). The most frequently used CAM among IBD patients was massage (21.3%), versus controls (31.4%) (adjusted P=0.0003). The second most used CAM was natural products, 18.7% in IBD patients versus 22.3% of the controls (unadjusted P=0.018). In all, 83.1% of the patients experienced positive effects from CAM and 14.4% experienced negative effects. CONCLUSION Overall, 48.3% of Swedish IBD patients used some kind of CAM and controls used CAM significantly more. Natural products were used by one-fifth of the patients and even more by controls. This is notable from a patient safety perspective considering the possible risks of interactions with conventional medication. In all, 40% of the patients reported adverse events from conventional medicine. Patients experienced predominantly positive effects from CAM, and so did controls.
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Switching Between Infliximab Originator and Biosimilar in Paediatric Patients with Inflammatory Bowel Disease. Preliminary Observations.
Sieczkowska, J, Jarzębicka, D, Banaszkiewicz, A, Plocek, A, Gawronska, A, Toporowska-Kowalska, E, Oracz, G, Meglicka, M, Kierkus, J
Journal of Crohn's & colitis. 2016;(2):127-32
Abstract
BACKGROUND AND AIMS The growing incidence of inflammatory bowel disease (IBD) in children necessitates the use of biological treatments. Recently, an infliximab biosimilar was authorized in the European Union, which may result in switching patients. We present our preliminary experiences with such switches. METHODS The prospective study included 32 paediatric patients diagnosed with Crohn's disease (CD) and 7 children with ulcerative colitis (UC) at 3 academic hospitals, who were switched from infliximab originator to its biosimilar (Remsima). Patient characteristics, disease severity, laboratory parameters and adverse events were recorded. Means, medians and ranges were calculated. RESULTS Mean age at diagnosis of CD and UC was 11.1 (2.7-15.3) and 12.3 years (8.5-14.8), respectively. Mean number of infliximab originator infusions before switching to the biosimilar was 9.9 (median 8, range 4-29) and 5.1 (5, 1-12) for the CD and UC group, respectively. Evaluation efficacy of last biosimilar doses of all patients revealed rates of clinical remission of 88 and 57% for CD and UC patients, respectively. Last follow-up assessment of patients who continued with biosimilar therapy showed that 16/20 (80%) CD patients and all 4 UC individuals were in remission. One infusion reaction to infliximab biosimilar was observed in a CD patient, which led to treatment discontinuation. The incidence of sporadic mild adverse events prior to and after switching did not differ significantly and was consistent with the safety profile of the infliximab molecule. CONCLUSION Switching from infliximab originator to its biosimilar seems to be a safe option in children with CD. After the switch the biosimilar was just as effective as the originator.
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TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD): Design and implementation of randomized clinical trial.
Cross, RK, Jambaulikar, G, Langenberg, P, Tracy, JK, Collins, JF, Katz, J, Regueiro, M, Schwartz, DA, Quinn, CC
Contemporary clinical trials. 2015;:132-44
Abstract
BACKGROUND Inflammatory bowel diseases (IBD), comprised of ulcerative colitis and Crohn's disease, are chronic disorders characterized by worsening of symptoms followed by symptom-free periods. Symptoms have a profound negative impact on quality of life and are associated with increased health care utilization. Despite effective treatments, outcomes are suboptimal secondary to nonadherence, medication intolerance, inconsistent monitoring, poor patient knowledge and limited access to care. OBJECTIVES Compare disease activity and quality of life over 1 year in a randomized trial of IBD patients receiving standard care versus telemedicine. METHODS Patients evaluated at 3 IBD referral centers with worsening symptoms within the last 2 years are eligible for randomization to one of two interventions or standard care. The interventions consist of either every other week or weekly assessment of symptoms, side effects, weight and delivery of medication prompts and education via texts to the participant's mobile phone. Individualized alerts and action plans are created on a secure portal. Participants in the standard care group undergo routine and urgent follow-up visits and telephone calls. The primary outcomes group comparisons of changes in disease activity and quality of life scores from baseline to 6 and 12 months. CONCLUSIONS Methods such as telemedicine are needed to improve monitoring, adherence, self-efficacy, and patient knowledge in IBD. If effective, telemedicine should decrease symptoms, improve quality of life, and decrease health care utilization. The burden associated with use of telemedicine for patients and providers needs to be assessed. The trial is ongoing and will be completed in July 2016.