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"Inflammatory Bowel Diseases - physiopathology"
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A Randomized Controlled Trial of TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD)
by
Regueiro, Miguel
,
Langenberg, Patricia
,
Schwartz, David A.
in
Abdomen
,
Adult
,
Colitis, Ulcerative - physiopathology
2019
Telemedicine has shown promise in inflammatory bowel disease (IBD). The objective of this study was to compare disease activity and quality of life (QoL) in a 1-year randomized trial of IBD patients receiving telemedicine vs. standard care.
Patients with worsening symptoms in the prior 2 years were eligible for randomization to telemedicine (monitoring via texts EOW or weekly) or standard care. The primary outcomes were the differences in change in disease activity and QoL between the groups; change in healthcare utilization among groups was a secondary aim.
348 participants were enrolled (117 control group, 115 TELE-IBD EOW, and 116 TELE-IBD weekly). 259 (74.4%) completed the study. Age was 38.9 ± 12.3 years, 56.6% were women, 91.9% were Caucasian, 67.9% had Crohn's disease (CD) and 42.5% had active disease at baseline. In CD, all groups experienced a decrease in disease activity (control -5.2 ± 5.0 to 3.7 ± 3.6, TELE-IBD EOW 4.7 ± 4.1 to 4.2 ± 3.9, and TELE-IBD weekly 4.2 ± 4.2 to 3.2 ± 3.4, p < 0.0001 for each of the groups) In UC, only controls had a significant decrease in disease activity (control 2.9 ± 3.1 to 1.4 ± 1.4, p = 0.01, TELE-IBD EOW 2.7 ± 3.1 to 1.7 ± 1.9, p = 0.35, and TELE-IBD Weekly 2.5 ± 2.5 to 2.0 ± 1.8, p = 0.31). QoL increased in all groups; the increase was significant only in TELE-IBD EOW (control 168.1 ± 34.0 to 179.3 ± 28.2, p = 0.06, TELE-IBD EOW 172.3 ± 33.1 to 181.5 ± 28.2, p = 0.03, and TELE-IBD Weekly 172.3 ± 34.5 to 179.2 ± 32.8, p = 0.10). Unadjusted and adjusted changes in disease activity and QoL were not significantly different among groups. Healthcare utilization increased in all groups. TELE-IBD weekly were less likely to have IBD-related hospitalizations and more likely to have non-invasive diagnostic tests and electronic encounters compared to controls; both TELE-IBD groups had decreased non-IBD related hospitalizations and increased telephone calls compared to controls.
Disease activity and QoL, although improved in all participants, were not improved further through use of the TELE-IBD system. TELE-IBD participants experienced a decrease in hospitalizations with an associated increase in non-invasive diagnostic tests, telephone calls and electronic encounters. Research is needed to determine if TELE-IBD can be improved through patient engagement and whether it can decrease healthcare utilization by replacing standard care.
Journal Article
Serum Calprotectin: A Novel Diagnostic and Prognostic Marker in Inflammatory Bowel Diseases
by
Wilson, David C
,
Boyapati, Ray K
,
Adams, Alex T
in
Adult
,
Area Under Curve
,
C-Reactive Protein - metabolism
2016
There is an unmet need for novel blood-based biomarkers that offer timely and accurate diagnostic and prognostic testing in inflammatory bowel diseases (IBD). We aimed to investigate the diagnostic and prognostic utility of serum calprotectin (SC) in IBD.
A total of 171 patients (n=96 IBD, n=75 non-IBD) were prospectively recruited. A multi-biomarker model was derived using multivariable logistic regression analysis. Cox proportional hazards model was derived to assess the contribution of each variable to disease outcomes.
SC correlated strongly with current biomarkers, including fecal calprotectin (FC) (n=50, ρ=0.50, P=1.6 × 10
). SC was the strongest individual predictor of IBD diagnosis (odds ratio (OR): 9.37 (95% confidence interval (CI): 2.82-34.68), P=4.00 × 10
) compared with other markers (C-reactive protein (CRP): OR 8.52 (95% CI: 2.75-28.63), P=2.80 × 10
); albumin: OR 6.12 (95% CI: 1.82-22.16), P=0.004). In a subset of 50 patients with paired SC and FC, the area under receiver operating characteristic discriminating IBD from controls was better for FC than for SC (0.99, (95% CI 0.87-1.00) and 0.87 (95% CI:0.78-0.97), respectively; P=0.01). At follow-up (median 342 days; interquartile range: 88-563), SC predicted treatment escalation and/or surgery in IBD (hazard ratio (HR) 2.7, 95% CI: 1.1-4.9), in particular Crohn's disease (CD) (HR 4.2, 95% CI 1.2-15.3). A model incorporating SC and either CRP or albumin has a positive likelihood ratio of 24.14 for IBD. At 1 year, our prognostic model can predict treatment escalation in IBD in 65% of cases (95% CI: 43-79%) and 80% (95% CI: 31-94%) in CD if ≥2 blood marker criteria are met.
A diagnostic and prognostic model that combines SC and other blood-based biomarkers accurately predicts the inflammatory burden in IBD and has the potential to predict disease and its outcomes. Our data warrant further detailed exploration and validation in large multicenter cohorts.
Journal Article
A Prospective Pilot Randomized Study: Electroacupuncture vs. Sham Procedure for the Treatment of Fatigue in Patients With Quiescent Inflammatory Bowel Disease
by
García-Molina, Susana
,
Lira, Alba
,
Teggiachi, Marcelo
in
Acupuncture
,
Adult
,
Care and treatment
2020
BackgroundFatigue is a common symptom in patients with inflammatory bowel disease (IBD), and it often persists despite clinical remission. Acupuncture has been shown to be effective for treating fatigue in patients with many chronic diseases. The main objective of the study was to assess the efficacy of electroacupuncture (EAc), compared with sham EAc (ShEAc) or being on a waitlist (WL), for treating fatigue in patients with quiescent IBD in a single-blind randomized trial.MethodsFifty-two patients with IBD in clinical remission and fatigue were randomly assigned to 1 of 3 groups: EAc, ShEAc, or WL. Patients in the EAc and ShEAc groups received 9 sessions over 8 weeks. Fatigue was evaluated with the IBD-validated Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-FS).ResultsBaseline characteristics were similar in the 3 groups. Both EAc and ShEAc presented improved Functional Assessment of Chronic Illness Therapy-Fatigue Scale scores compared with baseline: the respective improvements were 9.53 (95% confidence intervals, 6.75–12.3, P < 0.001) and 5.46 points (95% confidence intervals, 2.7–9.7, P = 0.015), respectively. No significant changes were observed in the WL group. In the comparison of treatment groups, EAc was nonsignificantly better than ShEAc (EAc, 33.27 and ShEAc, 28.13, P = 0.168); both EAc and ShEAc improved fatigue scores significantly compared to WL (24.5; P = 0.01 and 0.04, respectively).ConclusionsBoth EAc and ShEAc reduced fatigue scores in IBD patients when compared to WL. No differences were observed between EAc and ShEAc, although the study was not powered to rule out a difference. Acupuncture may offer improvements to patients with few other treatment alternatives. Clinical Trials Org Id: NCT02733276.Fatigue is common in patients with inflammatory bowel disease (IBD), and it often persists despite clinical remission. There are no efficacious therapies for the management of fatigue in patients with IBD. We aimed to evaluate the efficacy of electroacupuncture in patients with quiescent IBD.
Journal Article
Curcumin plus piperine improve body composition in patients with inflammatory bowel disease: a randomized, double-blind, placebo-controlled clinical trial
by
da Silva Gomes, Amanda
,
Neto, Manoel Álvaro de Freitas Lins
,
Moura, Fabiana Andréa
in
adjuvants
,
Adult
,
Alkaloids - administration & dosage
2025
This study evaluates the effects of oral supplementation of curcumin alone and curcumin plus piperine on body composition, phase angle, and functional capacity in patients with mild to moderate inflammatory bowel disease (IBD). Patients with a diagnosis of IBD, aged 18 years or older with intact kidney and liver function, were into three groups: placebo, curcumin (1000 mg/day), and curcumin plus piperine (1000 mg/day + 10 mg/day). Anthropometric markers, body composition, phase angle (via tetrapolar bioelectrical impedance analysis), and hand-grip strength were assessed before and after the 12-week supplementation period. Statistical analyses included Chi-square test (χ²) and generalized estimating equation (GEE) adjusted for age. Of the 58 patients who started the study, 51 completed it. Initially, obesity was prevalent according to BMI (43.1%) and body fat percentage (62.7%), while 86.3% exhibited muscle depletion based on fat-free mass (FFM). Post-intervention, the curcumin plus piperine group showed a significant reduction in muscle depletion, with improvements in FFM (χ²,
p
= 0.019; GEE,
p
= 0.049) and phase angle (χ²,
p
= 0.028) compared to the placebo group. In conclusion, our findings indicate that curcumin plus piperine significantly improves body composition by increasing muscle mass in patients with mild to moderate IBD, suggesting its potential as an adjuvant therapy.
Trial registration
: This trial was registered at ensaiosclinicos.gov.br as RBR89q4ydz on July 20, 2023. Website
https://ensaiosclinicos.gov.br/
.
Journal Article
Cognitive behavioural therapy for the management of inflammatory bowel disease-fatigue with a nested qualitative element: study protocol for a randomised controlled trial
by
Sturt, Jackie
,
Czuber-Dochan, Wladyslawa
,
Norton, Christine
in
Behavior modification
,
Biomedicine
,
Clinical Protocols
2017
Background
Fatigue is one of the most prevalent and burdensome symptoms for patients with inflammatory bowel disease (IBD). Although fatigue increases during periods of inflammation, for some patients it persists when disease is in remission. Compared to other long-term conditions where fatigue has been extensively researched, optimal management of fatigue in patients with IBD is unknown and fatigue has rarely been the primary outcome in intervention studies. To date, interventions for the management of IBD-fatigue are sparse, have short-term effects and have not been implemented within the existing health system. There is a need to integrate current best evidence across different conditions, patient experience and clinical expertise in order to develop interventions for IBD-fatigue management that are feasible and effective. Modifying an existing intervention for patients with multiple sclerosis, this study aims to assess the feasibility and initial estimates of efficacy of a cognitive behavioural therapy (CBT) intervention for the management of fatigue in patients with IBD.
Methods
The study will be a two-arm pilot randomised controlled trial. Patients will be recruited from one outpatient IBD clinic and randomised individually to either: Group 1 (CBT manual for the management of fatigue, one 60-min session and seven 30-min telephone/Skype sessions with a therapist over an eight-week period); or Group 2 (fatigue information sheet to use without therapist help). Self-reported IBD-fatigue (Inflammatory Bowel Disease-Fatigue Scale) and IBD-quality of life (United Kingdom Inflammatory Bowel Disease Questionnaire) and self-reported disease activity will be collected at baseline, three, six and 12 months post randomisation. Illness perceptions, daytime sleepiness, anxiety and depression explanatory variables will be collected only at three months post randomisation. Clinical and sociodemographic data will be retrieved from the patients’ medical notes. A nested qualitative study will evaluate patient and therapist experience, and healthcare professionals’ perceptions of the intervention.
Discussion
The study will provide evidence of the feasibility and initial estimates of efficacy of a CBT intervention for the management of fatigue in patients with IBD. Quantitative and qualitative findings from the study will contribute to the development and implementation of a large-scale randomised controlled trial assessing the efficacy of CBT interventions for IBD-fatigue.
Trial registration
ISRCTN Registry,
ISRCTN17917944
. Registered on 2 September 2016.
Journal Article
Pathophysiology of Inflammatory Bowel Diseases
2020
Research on IBDs has identified disrupted immune responses in the gastrointestinal mucosa and putative disruptions in the gut microbiome as causative agents. This work has led to better therapeutic control of IBDs with the use of various antiinflammatory agents.
Journal Article
Host–microbe interactions have shaped the genetic architecture of inflammatory bowel disease
by
Newman, William
,
Boucher, Gabrielle
,
Potocnik, Uros
in
631/208/205/2138
,
631/250/255/1318
,
692/420
2012
A meta-analysis of previous genome-wide association studies of Crohn’s disease and ulcerative colitis, the two most common forms of inflammatory bowel disease, with a combined total of more than 75,000 cases and controls, finds that most loci contribute to both phenotypes and other immune-mediated disorders.
Pathogenesis of inflammatory bowel disease
Genetic studies have implicated unsuspected mechanisms in the pathogenesis of Crohn's disease and ulcerative colitis, two of the most common forms of inflammatory bowel disease. This paper presents a meta-analysis of published genome-wide association studies, together with validation in more than 75,000 cases and controls. In addition to several new associations, the authors find that most loci contribute to both phenotypes, but also to other immune-mediated disorders. The data reveal an overlap between susceptibility loci for inflammatory bowel disease and mycobacterial infection, and between the pathways that govern host responses to mycobacteria and those predisposing to inflammatory bowel disease.
Crohn’s disease and ulcerative colitis, the two common forms of inflammatory bowel disease (IBD), affect over 2.5 million people of European ancestry, with rising prevalence in other populations
1
. Genome-wide association studies and subsequent meta-analyses of these two diseases
2
,
3
as separate phenotypes have implicated previously unsuspected mechanisms, such as autophagy
4
, in their pathogenesis and showed that some IBD loci are shared with other inflammatory diseases
5
. Here we expand on the knowledge of relevant pathways by undertaking a meta-analysis of Crohn’s disease and ulcerative colitis genome-wide association scans, followed by extensive validation of significant findings, with a combined total of more than 75,000 cases and controls. We identify 71 new associations, for a total of 163 IBD loci, that meet genome-wide significance thresholds. Most loci contribute to both phenotypes, and both directional (consistently favouring one allele over the course of human history) and balancing (favouring the retention of both alleles within populations) selection effects are evident. Many IBD loci are also implicated in other immune-mediated disorders, most notably with ankylosing spondylitis and psoriasis. We also observe considerable overlap between susceptibility loci for IBD and mycobacterial infection. Gene co-expression network analysis emphasizes this relationship, with pathways shared between host responses to mycobacteria and those predisposing to IBD.
Journal Article
Different levels of healing in inflammatory bowel diseases: mucosal, histological, transmural, barrier and complete healing
by
Vieth, Michael
,
Neurath, Markus F
in
Anti-Inflammatory Agents - therapeutic use
,
Biopsy
,
Clinical trials
2023
Mucosal healing on endoscopy has emerged as a key prognostic parameter in the management of patients with IBD (Crohn’s disease, ulcerative colitis/UC) and can predict sustained clinical remission and resection-free survival. The structural basis for this type of mucosal healing is a progressive resolution of intestinal inflammation with associated healing of ulcers and improved epithelial barrier function. However, in some cases with mucosal healing on endoscopy, evidence of histological activity in mucosal biopsies has been observed. Subsequently, in UC, a second, deeper type of mucosal healing, denoted histological healing, was defined which requires the absence of active inflammation in mucosal biopsies. Both levels of mucosal healing should be considered as initial events in the resolution of gut inflammation in IBD rather than as indicators of complete transmural healing. In this review, the effects of anti-inflammatory, biological or immunosuppressive agents as well as small molecules on mucosal healing in clinical studies are highlighted. In addition, we focus on the implications of mucosal healing for clinical management of patients with IBD. Moreover, emerging techniques for the analysis of mucosal healing as well as potentially deeper levels of mucosal healing such as transmural healing and functional barrier healing of the mucosa are discussed. Although none of these new levels of healing indicate a definitive cure of the diseases, they make an important contribution to the assessment of patients’ prognosis. The ultimate level of healing in IBD would be a resolution of all aspects of intestinal and extraintestinal inflammation (complete healing).
Journal Article
Effect of Lifestyle Factors on Outcomes in Patients With Inflammatory Bowel Diseases
by
Holmer, Ariela
,
Singh, Siddharth
,
Rozich, Jacob J.
in
Abdomen
,
Abdominal surgery
,
Alcohol Drinking - epidemiology
2020
Various lifestyle factors including physical activity and obesity, stress, sleep, and smoking may modify the risk of developing inflammatory bowel diseases (IBDs). In patients with established IBD, these lifestyle factors may significantly impact the natural history and clinical outcomes. Recreational exercise decreases the risk of flare and fatigue in patients with IBD. In contrast, obesity increases the risk of relapse and is associated with higher anxiety, depression, fatigue, and pain and higher health care utilization. Obesity also modifies pharmacokinetics of biologic agents unfavorably and is associated with a higher risk of treatment failure. Sleep disturbance is highly prevalent in patients with IBD, independent of disease activity, and increases the risk of relapse and chronic fatigue. Similarly, stress, particularly perceived stress rather than major life events, may trigger symptomatic flare in patients with IBD, although its impact on inflammation is unclear. Cigarette smoking is associated with unfavorable outcomes including the risk of corticosteroid dependence, surgery, and disease progression in patients with Crohn's disease; in contrast, smoking does not significantly impact outcomes in patients with ulcerative colitis, although some studies suggest that it may be associated with a lower risk of flare. The effect of alcohol and cannabis use in patients with IBD is inconsistent, with some studies suggesting that cannabis may decrease chronic pain in patients with IBD, without a significant effect of biological remission. Although these lifestyle factors are potentially modifiable, only a few interventional studies have been conducted. Trials of structured exercise and psychological therapy including mindfulness-based therapies such as meditation and yoga and gut-directed hypnotherapy have not consistently demonstrated benefit in clinical and/or endoscopic disease activity in IBD, although may improve overall quality of life.
Journal Article
Faecal incontinence intervention study (FINS): self-management booklet information with or without nurse support to improve continence in people with inflammatory bowel disease: study protocol for a randomized controlled trial
2015
Background
Inflammatory bowel disease, comprising Crohn’s disease and ulcerative colitis, is a life-long currently incurable illness. It causes bouts of acute intestinal inflammation, in an unpredictable relapsing-remitting course, with bloody diarrhoea and extreme urgency to access a toilet. Faecal incontinence is a devastating social and hygiene problem, impacting heavily on quality of life and ability to work and socialise. Faecal incontinence affects 2–10 % of adults in the general population. People with inflammatory bowel disease have a high risk of incontinence with up to 74 % affected. No previous study has explored conservative interventions for these patients.
Methods
This randomised controlled trial will recruit 186 participants to answer the research question: does implementation of the UK nationally recommended guidance approach to stepwise management of faecal incontinence improve bowel control and quality of life in people with inflammatory bowel disease? We have worked with people with inflammatory bowel disease to translate this guidance into a condition-specific information booklet on managing incontinence. We will randomise participants to receive the booklet, or the booklet plus up to four 30-minute sessions with an inflammatory bowel disease specialist nurse. To be eligible, patients must be in disease remission and report incontinence. The primary outcome measure at 6 months after randomisation is the St Mark’s incontinence score. Other outcomes include quality of life, MY-MOP (generic tool: participants set two goals for intervention, grading goals at baseline and then re-scoring after intervention) and EQ-5D-5 L to enable calculation of quality-adjusted life years. Analysis will be on an intention-to-treat basis. Qualitative interviews will explore participant and health professionals’ views on the interventions.
Discussion
Few high-quality studies of conservative interventions in inflammatory bowel disease, and none for faecal incontinence, have been conducted. We have collaborated with patients to design this study. Blinding to this behavioural intervention is not possible, but our self-report outcome measures with a degree of objectivity. There is genuine equipoise between the booklet only and booklet plus nurse arms, and the study will determine if additional support from a nurse is a crucial element in implementing advice.
Trial registration
clinitrials.gov.uk:
NCT02355834
(Date of registration: 12 December 2014).
Protocol version: 4.0. 08.04.15
Journal Article