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An Autoimmune Protocol Diet Improves Patient-Reported Quality of Life in Inflammatory Bowel Disease.

ABSTRACT: Background:Prior studies suggest dietary modification may improve clinical response or remission rates in patients with inflammatory bowel disease (IBD). Our aim was to examine whether an autoimmune protocol diet improves quality of life in patients with active Crohn disease (CD) and ulcerative colitis (UC). Methods:We conducted an uncontrolled clinical trial of the autoimmune protocol diet in adult patients with active IBD (Harvey-Bradshaw Index ? 5 for CD or partial Mayo score ? 3 for UC, and erosions/ulcers on endoscopy and/or elevated fecal calprotectin). The dietary intervention consisted of a 6-week elimination phase, followed by a 5-week maintenance phase. Short Inflammatory Bowel Disease Questionnaire (SIBDQ) was completed at baseline, and weeks 3, 6, 9, and 11. Results:The final cohort included 6 UC and 9 CD participants. Mean SIBDQ score improved significantly from baseline (46.5) to weeks 3 (54.0, P = 0.02), 6 (53.3, P = 0.02), 9 (62.0, P = 0.03), and 11 (60.5, P = 0.05). Among participants completing all 5 surveys, mean SIBDQ increased from 46.5 to 61.5 by week 11 (P = 0.03). By week 3, participants experienced significant improvements in bowel movement frequency (36%, P = 0.04), stress (28%, P = 0.01), and ability to perform leisure/sport activities (29%, P = 0.02). Effects were not significantly different between CD and UC participants. Conclusions:Dietary modification can improve quality of life as early as week 3 in patients with active IBD. Larger randomized controlled trials are needed to examine dietary interventions in IBD.

SUBMITTER: Chandrasekaran A

PROVIDER: S-EPMC6892563 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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An Autoimmune Protocol Diet Improves Patient-Reported Quality of Life in Inflammatory Bowel Disease.

Chandrasekaran Anita A Groven Shauna S Lewis James D JD Levy Susan S SS Diamant Caroline C Singh Emily E Konijeti Gauree Gupta GG

Crohn's & colitis 360 20190807 3

<h4>Background</h4>Prior studies suggest dietary modification may improve clinical response or remission rates in patients with inflammatory bowel disease (IBD). Our aim was to examine whether an autoimmune protocol diet improves quality of life in patients with active Crohn disease (CD) and ulcerative colitis (UC).<h4>Methods</h4>We conducted an uncontrolled clinical trial of the autoimmune protocol diet in adult patients with active IBD (Harvey-Bradshaw Index ≥ 5 for CD or partial Mayo score ≥ ...[more]

PMID: 31832627

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Project description:BackgroundDigital patient reported outcomes are used increasingly in daily care and treatment of inflammatory bowel disease. Their purpose includes increased focus on patient wellbeing, reduction in avoidable follow-up consultations and increased patient self-management. However, implementation issues occur and studies indicate patients may have concerns, particularly regarding having fewer face-to-face consultations. This study aims to explore patients' perspectives of use and non-use of digital patient reported outcomes and to understand the mechanisms underpinning patient reluctance to engage with this health technology.ResultsSixteen patients with inflammatory bowel disease at a regional hospital in Denmark were interviewed about their experiences of, and perspectives on, digital patient reported outcomes. A certain level of eHealth literacy was found to be a fundamental condition for use, while other factors were barriers or facilitators for use of digital PROs. Patients' main concerns were about potential consequences for their care and relationship with the clinic. Most patients in stable remission were satisfied with the hospital being a "life-line" if their symptoms worsened, and perceived digital patient reported outcomes to be an efficient tool to establish that "life-line". Patients with severe symptoms and a high degree of emotional distress related to their disease valued the potential for digital patient reported outcomes to increase their clinicians' focus on mental health and extra-intestinal symptoms.ConclusionThis study found that if patients had sufficient digital literacy, they perceived digital patient reported outcomes to be a useful replacement for face-to-face consultations. However, they were concerned about digital patient reported outcomes' effect on the patient-clinician relationship and its ability to detect worsening of symptoms. These concerns may be mitigated by good patient-clinician relationships, and the option for patients to maintain direct telephone contact with their gastroenterology specialist.

Project description:BackgroundQuality of life (QOL) can be significantly impacted by symptoms of overactive bladder (OAB). Vibegron is a highly selective β3 -adrenergic receptor agonist that showed efficacy in treatment of symptoms of OAB in the randomised, double-blind, placebo- and active-controlled phase 3 EMPOWUR trial. Here we report patient-reported QOL outcomes from the EMPOWUR trial.MethodsPatients were randomly assigned 5:5:4 to receive vibegron 75 mg, placebo or tolterodine 4 mg extended release, respectively, for 12 weeks. Patients completed the OAB questionnaire (OAB-q) at baseline and at week 12 and the patient global impression (PGI) scales for severity, control, frequency and leakage at baseline and at weeks 4, 8 and 12. Change from baseline at week 12 and responder rates (OAB-q: patients achieving a ≥10-point improvement; PGI: patients reporting best possible response) were assessed. Vibegron was compared with placebo, and no comparisons were made between vibegron and tolterodine.ResultsOf the 1518 patients randomised, 1463 (placebo, n = 520; vibegron, n = 526; tolterodine, n = 417) had evaluable data for efficacy measures and were included in the analysis. Mean baseline OAB-q and PGI scores were comparable among treatment groups. At week 12, patients receiving vibegron had greater improvements from baseline in OAB-q subscores of coping, concern, sleep, health-related QOL total and symptom bother (P < .01 each) compared with patients receiving placebo; a greater proportion of patients receiving vibegron vs placebo were responders in the OAB-q coping (P < .05) and symptom bother scores (P < .0001). Compared with placebo, a greater proportion of patients who received vibegron achieved the best response on all PGI end-points at week 12 (P < .05 each) and were classified as responders (P < .05 each).ConclusionsIn the 12-week EMPOWUR trial, treatment with vibegron was associated with significantly greater and clinically meaningful improvement in OAB-q and PGI scores compared with placebo, consistent with improvements in OAB symptoms.Clinical trial registrationClinicalTrials.gov identifier number NCT03492281.

Dataset Information

An Autoimmune Protocol Diet Improves Patient-Reported Quality of Life in Inflammatory Bowel Disease.

Publications

An Autoimmune Protocol Diet Improves Patient-Reported Quality of Life in Inflammatory Bowel Disease.

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