scholarly journals A237 IMPROVEMENT IN ABDOMINAL SYMPTOMS WITH LINACLOTIDE IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION: RESULTS FROM A PHASE 3B TRIAL

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 287-288
Author(s):  
S Sidani ◽  
K Boutros ◽  
G S Sayuk ◽  
H Gonzalez ◽  
D M Brenner
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Primary Endpoint ◽  
Repeated Measures ◽  
Mixed Model ◽  
Abdominal Symptom ◽  
Double Blind ◽  
Abdominal Bloating ◽  
Abdominal Symptoms ◽  
Irritable Bowel

Abstract Background Linaclotide (LIN) is a guanylate cyclase-C agonist approved to treat irritable bowel syndrome with constipation (IBS-C) in adults. Abdominal symptoms are important to patients with IBS-C. In a recent Phase 3b study, LIN significantly improved a composite score of abdominal bloating, pain, and discomfort (Abdominal Score), which was used as the primary endpoint in the study. Aims To evaluate the efficacy of LIN for improving additional efficacy abdominal symptom endpoints in a randomized, double-blind, placebo (PBO)-controlled Phase 3 study of LIN in patients with IBS-C. Methods Adults with IBS-C were randomized to PBO (N=308) or LIN 290 μg (N=306) once daily for 12 weeks. Patients recorded their daily abdominal symptoms, including the individual items of bloating, pain, and discomfort, using an 11-point scale (0–10; 0=none, 10=worst possible). The primary endpoint was the Abdominal Score. Additional efficacy endpoints included 6/12-week abdominal pain and constipation (APC)+1 responder, 6/12-week abdominal bloating responder, 6/12-week abdominal pain responder, and 6/12-week abdominal discomfort responder. For individual symptoms, a responder was a patient who had an improvement from baseline of ≥2 points in the respective endpoint for ≥6 of the 12 weeks. Changes from baseline (CFB) over 12 weeks in abdominal bloating, pain, and discomfort were evaluated using a mixed model with repeated measures framework. Proportions of responders were compared between groups for each responder endpoint using a Cochran-Mantel-Haenszel test. Results 614 patients (mean age, 46.7 years; 81% female; similar baseline abdominal symptoms) were randomized. LIN-treated patients had greater least-squares mean (LSM) CFB in abdominal bloating (LSM difference [95% CI]: –0.889 [–1.249, –0.530], p<0.001), pain (–0.881 [–1.238, –0.524], p<0.001), and discomfort (–0.837 [–1.196, –0.478], p<0.001) compared to PBO-treated patients. There was a greater proportion of LIN-treated vs. PBO-treated patients who were 6/12-week APC+1 (29% vs. 17%; p=0.0003), bloating (40% vs. 24%; p<0.001), pain (42% vs. 25%; p<0.001), and discomfort (42% vs. 26%; p<0.001) responders (Figure). Diarrhea was the most common treatment-emergent adverse event (LIN: 4.6%; PBO: 1.6%). Conclusions LIN significantly improved multiple abdominal symptom and secondary responder endpoints in patients with IBS-C. These results support the effectiveness of LIN for improving a spectrum of abdominal symptoms in IBS-C. Funding Agencies This study was sponsored by Allergan plc, Dublin, Ireland (prior to acquisition by AbbVie Inc.). Writing and editorial assistance were provided to the authors by Brittany Y. Jarrett, PhD, Jane Beck, MA, and Rebecca Fletcher, BA(Hons) of Complete HealthVizion, Inc., Chicago, IL, USA and funded by Allergan plc (prior to acquisition by AbbVie Inc.).

scholarly journals Psyllium Fiber Reduces Abdominal Pain in Children With Irritable Bowel Syndrome in a Randomized, Double-Blind Trial

2017 ◽  
Vol 15 (5) ◽  
pp. 712-719.e4 ◽  
Author(s):  
Robert J. Shulman ◽  
Emily B. Hollister ◽  
Kevin Cain ◽  
Danita I. Czyzewski ◽  
Mariella M. Self ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
Irritable Bowel

scholarly journals Efficacy of a low FODMAP diet in irritable bowel syndrome: systematic review and network meta-analysis

Gut ◽  
2021 ◽  
pp. gutjnl-2021-325214
Author(s):  
Christopher J. Black ◽  
Heidi M. Staudacher ◽  
Alexander C. Ford
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Meta Analysis ◽  
Tertiary Care ◽  
Bowel Habit ◽  
Dietary Advice ◽  
Abdominal Bloating ◽  
Irritable Bowel ◽  
Fodmap Diet ◽  
The Impact

ObjectiveA diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) is recommended for irritable bowel syndrome (IBS), if general lifestyle and dietary advice fails. However, although the impact of a low FODMAP diet on individual IBS symptoms has been examined in some randomised controlled trials (RCTs), there has been no recent systematic assessment, and individual trials have studied numerous alternative or control interventions, meaning the best comparator is unclear. We performed a network meta-analysis addressing these uncertainties.DesignWe searched the medical literature through to 2 April 2021 to identify RCTs of a low FODMAP diet in IBS. Efficacy was judged using dichotomous assessment of improvement in global IBS symptoms or improvement in individual IBS symptoms, including abdominal pain, abdominal bloating or distension, and bowel habit. Data were pooled using a random effects model, with efficacy reported as pooled relative risks (RRs) with 95% CIs, and interventions ranked according to their P-score.ResultsWe identified 13 eligible RCTs (944 patients). Based on failure to achieve an improvement in global IBS symptoms, a low FODMAP diet ranked first vs habitual diet (RR of symptoms not improving=0.67; 95% CI 0.48 to 0.91, P-score=0.99), and was superior to all other interventions. Low FODMAP diet ranked first for abdominal pain severity, abdominal bloating or distension severity and bowel habit, although for the latter it was not superior to any other intervention. A low FODMAP diet was superior to British Dietetic Association (BDA)/National Institute for Health and Care Excellence (NICE) dietary advice for abdominal bloating or distension (RR=0.72; 95% CI 0.55 to 0.94). BDA/NICE dietary advice was not superior to any other intervention in any analysis.ConclusionIn a network analysis, low FODMAP diet ranked first for all endpoints studied. However, most trials were based in secondary or tertiary care and did not study effects of FODMAP reintroduction and personalisation on symptoms.

Evaluation Of Irritable Bowel Syndrome Symptoms Amongst Warsaw University Students

2015 ◽  
Vol 87 (5) ◽  
Author(s):  
Sylwia Niemyjska ◽  
Anna Ukleja ◽  
Michał Ławiński
Keyword(s):  
Physical Activity ◽  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
University Students ◽  
Functional Gastrointestinal Disorders ◽  
Chi Square ◽  
Abdominal Symptoms ◽  
Intestinal Infections ◽  
Chi Square Test ◽  
Irritable Bowel

AbstractIrritable bowel syndrome (IBS) belongs to functional gastrointestinal disorders and is characterized by abdominal pain and change in stool consistency and/or bowel habits. Etiological factors include gastrointestinal peristalsis disturbances, visceral hypersensitivity, chronic inflammation of the mucous membrane, dysbacteremia, intestinal infections, psychosomatic and nutritional factors. Gastrointestinal motility disturbances in case of IBS are manifested by the inhibition of the intestinal passage, which favors the development of constipation or occurrence of diarrhea.was to evaluate IBS symptoms and demonstrate the relationship between physical activity and place of residence amongst Warsaw University students.The study was conducted in march, 2014 using a specific questionnaire, amongst Warsaw University students. The study group comprised 120 female patients, aged between 19 and 27 years (M=23.43; SD=1.29). The chi-square test was used for analysis, p<0.05 was considered as statistically significant.The BMI of investigated patients ranged between 16.30-31.22 kg/mIBS symptoms are common amongst Warsaw University students. In case of respondents with low physical activity, abdominal pain or discomfort occurred more often. It has been demonstrated that diet and stress might contribute to the occurrence of abdominal symptoms, being evidence of IBS.

scholarly journals Effects of Propolis Supplementation on The Severity of Disease In Irritable Bowel Syndrome Subjects: A Randomized, Double-Blind Clinical Trial

2021 ◽  
Author(s):  
Mahsa Miryan ◽  
Pejman Alavinejad ◽  
Mohammadreza Abbaspour ◽  
Davood Soleimani ◽  
Alireza Ostadrahimi
Keyword(s):  
Quality Of Life ◽  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Repeated Measures ◽  
Study Groups ◽  
T Test ◽  
Anxiety State ◽  
Anthropometric Indices ◽  
Irritable Bowel

Abstract The effects of propolis, a well-known functional food, on irritable bowel syndrome (IBS), a chronic gastrointestinal disorder, in humans have yet to be investigated. This study evaluated propolis effects in IBS subjects. In this clinical study, 56 patients with IBS diagnosed by Rome IV criteria were assigned for 6 weeks randomly to the study groups. At the baseline and endpoint phase, patients’ gastrointestinal symptoms, quality of life (QOL), anxiety state, dietary intakes, and anthropometric indices were assessed. Independent t-test, paired t-test, Mann-Whitney U test, Wilcoxon, Fisher's exact test, repeated measures analysis of variance and logistic regression test were used for analyzing the data. To adjust the effect of confounders, covariance analysis was used. The results of this study showed that after modulating the effect of potential confounders, propolis supplementation increased the chance of improving IBS severity by 6.22 (with a confidence interval of: 1.33 - 1.14 and P = 0.035). A significant abdominal pain improvement, anxiety state, and bowel habits dissatisfaction reduction was observed within- and between-group differences in propolis group compared to the placebo group (P = 0.040, P = 0.035, P = 0.029, retrospectively). The overall score of quality of life and its domains in the propolis group was statistically significant, but in comparison between the two groups, this difference was not significant. Also, regards to the food intakes and anthropometric indices, there were no significant differences between and within the two study groups. This study illustrated that propolis supplementation could be used as adjunctive therapy in IBS disease to reduce abdominal pain and anxiety state.

Understanding Functional Bowel Disorders

2012 ◽  
Author(s):  
Jenny Gordon
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Functional Gastrointestinal Disorders ◽  
Gastrointestinal Disorders ◽  
Functional Bowel Disorders ◽  
Abdominal Symptoms ◽  
Bowel Disorders ◽  
Health Nursing ◽  
Functional Bloating ◽  
Irritable Bowel

The aim of this chapter is to provide nurses with the knowledge to be able to assess, manage, and care for people with the group of conditions often described as functional bowel disorders (FBD)—see definitions below—in an evidence-based and person-centred way. The chapter will provide an overview of the causes and impact of FBDs, before exploring best practice to deliver care, as well as to prevent or to minimize further ill-health. Nursing assessments and priorities are highlighted throughout, and the nursing management of the symptoms and common health problems associated with FBDs can be found in Chapters 16, 23, 24, and 25, respectively. This chapter discusses the group of conditions often described as functional bowel disorders (FBDs). The term ‘functional gastrointestinal disorders’ is also used in the literature, but, for the purpose of this book, the term FBDs will be adopted. This refers to a group of disorders that are characterized by chronic gastrointestinal symptoms that currently have an unknown structural or biochemical cause that could explain those symptoms. Rome III is an internationally agreed set of diagnostic criteria and related information on functional gastrointestinal disorders (Longstreth et al., 2006). It includes six major domains for adults: oesophageal; gastro/duodenal; bowel; functional abdominal pain syndrome; biliary; and anorectal. This chapter will cover the FBDs that specifically relate to chronic abdominal symptoms. General abdominal symptoms include functional dyspepsia, non-cardiac chest pain, which may mimic functional abdominal symptoms, chronic abdominal pain, functional constipation, functional diarrhoea, functional bloating, and irritable bowel syndrome (IBS). The chapter will concentrate on irritable bowel syndrome. Coeliac disease and Crohn’s disease are included: to give an understanding of these disorders, and to differentiate between inflammatory and non-inflammatory conditions; to highlight the impact of the symptoms on the people who suffer from them; and to give an insight into the contribution that effective nursing makes. The amount of research and the number of publications concerning FBDs has risen considerably since the mid 1990s, and has contributed to the increasing legitimacy of these conditions as disorders in their own right and not simply by virtue of exclusion of all other possibilities.

scholarly journals Efficacy and Safety of New Lactobacilli Probiotics for Unconstipated Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (12) ◽  
pp. 2887 ◽  
Author(s):  
Joo Hyun Oh ◽  
Yeon Sil Jang ◽  
Danbee Kang ◽  
Dong Kyung Chang ◽  
Yang Won Min
Keyword(s):  
Irritable Bowel Syndrome ◽  
Controlled Trial ◽  
Gastrointestinal Disorder ◽  
New Combination ◽  
Double Blind ◽  
Vas Score ◽  
Abdominal Symptoms ◽  
Significant Difference ◽  
Placebo Capsule ◽  
Irritable Bowel

Irritable bowel syndrome (IBS) is a common and chronic gastrointestinal disorder. Probiotics may have the potential to impact the management of IBS; however, the results of trials are conflicting. This study aimed to investigate whether a mixture of lactobacilli probiotics could improve abdominal symptoms in patients with unconstipated IBS. Fifty Vietnamese patients with unconstipated IBS were randomly assigned to either the probiotics or placebo groups. During the intervention, participants took the probiotic supplement, named Foodis Lactobacillus, or placebo capsule once a day. Patients recorded their subject global assessment (SGA) weekly and were assessed with the visual analogue scale (VAS) during the 4-week study period. Patients with SGA score of 2 points or more or a decrease of more than 30% in VAS score were considered responders. Patients who responded weekly for more than 2 of the 4 weeks were considered overall responders. There was no significant difference in demographic characteristics between the groups. Overall responder rates of improvement of global IBS symptoms assessed by SGA score were significantly higher in the probiotics group (80.8%) than in the placebo group (45.8%) (p = 0.009). The overall responder rates assessed by VAS score were also higher in the probiotics group (69.2%, 41.7%, p = 0.048). There were no adverse events in either group during the study period. Our findings suggest that the new combination of Lactobacilli appears to be promising in the relief of abdominal symptoms in Vietnamese patients with unconstipated IBS.

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