For Functional Gastrointestinal Disorders Research Articles

Performance of an algorithm-based approach to the diagnosis and management of functional gastrointestinal disorders: A pilot trial.

Recent advances in the development of diagnostic criteria and effective management options for functional gastrointestinal disorders (FGIDs) have not yet been integrated into clinical practice. There is a clear need for the development and validation of a simple clinical pathway for the diagnosis and management of FGIDs which can be used in primary care. In this controlled pilot study, we designed and evaluated a non-specialist-dependent, algorithm-based approach for the diagnosis and management of FGIDs (ADAM-FGID). Patients referred to 1 tertiary referral center with clinically suspected functional gastrointestinal disorders were allocated to waitlist control or algorithm group. The algorithm group was screened for organic disease, and those without clinical alarms received a written FGID diagnosis and management options. All participants were followed up for 1year. The ADAM-FGID was found to be feasible and acceptable to both patients and primary healthcare providers. The diagnostic component identified that 39% of referrals required more urgent gastroenterological review than original triage category, with organic disease subsequently diagnosed in 31% of these. The majority of patients (82%) diagnosed with a FGID did not receive a relevant alternative diagnosis during follow-up. Patient buy-in to the model was good, with all reading the diagnostic/management letter, 80% entering management, and 61% reporting symptom improvement at 6weeks. Moreover, 68% of patients and all referring doctors found the approach to be at least moderately acceptable. Patients reported being reassured by the approach and found the management options useful. Primary healthcare providers acknowledged the potential of this approach to reduce waiting times for endoscopic procedures and to provide reassurance to both patients and themselves. This pilot study provides preliminary evidence to support a clinical pathway for the diagnosis and management of FGIDs which does not depend upon specialist review. Further rigorous testing within primary care is needed to conclusively establish safety and efficacy. However, this approach is safer than current management and has potential to build capacity by reducing specialist burden and expediting effective care.

Psychological Factors Influence the Irritable Bowel Syndrome and Their Effect on Quality of Life among Firefighters in South Korea.

ObjectiveThe purpose of this study was to investigate the characteristics of psychological factors that are related to irritable bowel syndrome (IBS) and their effects on the quality of life (QOL) of firefighters in South Korea.MethodsThis study examined data collected from 1217 firefighters in South Korea. After identifying firefighters with IBS according to the Rome III diagnostic criteria for functional gastrointestinal disorders (FGIDs), we collected demographic data and psychological variables through self-administered questionnaires. In order to observe the distribution of the high-risk group in the Korean occupational stress scale (KOSS) subcategories, we conducted logistic multiple linear regression. The correlations between psychological factors and QOL were analyzed and we performed a stepwise regression analysis.ResultsThe groups (firefighters with and without IBS) showed differences by sex, working period, task, working pattern, Patient Health Questionnaire-9, Generalized Anxiety Disorder Questionnaire-7, Korean Occupational Stress Scale, Rosenberg's Self-Esteem Scale, and the World Health Organization Quality of Life-BREF. IBS risk was higher in the following KOSS subcategories: job demand (OR 1.79, 95% CI: 1.11–2.89), interpersonal conflict (OR 2.21, 95% CI: 1.25–4.33), organizational system (OR 1.87, 95% CI: 0.58–3.30), and lack of reward (OR 2.39, 95% CI: 1.08–5.26). The final regression model explained 42.6% of the variance in overall quality of life.ConclusionThe findings of this study indicate that a number of psychological factors increase the likelihood of irritable bowel syndrome (IBS) and affect QOL. Therefore, when diagnosing IBS in the future, mental health aspects should be considered in addition to physical health.

Probiotics for Irritable Bowel Syndrome

ABSTRACTPurpose of review:The purpose of this review was to summarize the evidence regarding probiotics treatment for pediatric IBS.Recent findings:The overall management of children with IBS should be tailored to the patient's specific symptoms and identifiable triggers. The four major therapeutic approaches include: pharmacologic, dietary, psychosocial, and complementary/alternative medicine interventions.Although there is limited evidence for efficacy of pharmacological therapies such as antispasmodics and anti‐diarrheals, these may have a role in severe cases. A Cochrane review concluded that only weak evidence exists regarding beneficial effects of pharmacological agents in providing relief from symptoms in functional abdominal pain (AP) in children. Role of antibiotics in treatment of children with IBS remains controversial. Various non‐pharmacologic treatments are available for pediatric IBS. In a recent systematic review including 24 studies some evidence was found indicating beneficial effects of partially hydrolyzed guar gum (PHGG), cognitive behavioral therapy, hypnotherapy, and probiotics (LGG and VSL#3).Few randomized clinical trials (RCTs) are available in children. A meta‐analysis including 9 trials which tested different probiotics as a treatment for Functional Gastrointestinal Disorders (FGIDs) in children and adolescents concluded that Lactobacillus GG, Lactobacillus reuteri DSM 17938 and VSL#3 significantly increased treatment success. We recently showed that, in children with IBS, a mixture of Bifidobacterium infantis M‐63®, breve M‐16V® and longum BB536® is safe and is associated with better AP control and improved quality of life when compared to placebo.Summary:Probiotics are emerging as new therapeutic tools in FGIDs, due to the recognition of the importance of gut microbiota in influencing brain‐gut interactions, and of the role played by intestinal infections in the genesis of AP‐FGIDs. Preclinical data suggest that changes in the gut microbiota can affect brain signaling systems related to pain and associated emotional behavior. Therefore, probiotics could play a relevant role in the management of FGIDs, by affecting the gut microbiota or by altering brain function and pain perception centrally.

Development and Validation of the Rome IV Diagnostic Questionnaire for Adults

The Rome IV Diagnostic Questionnaires were developed to screen for functional gastrointestinal disorders (FGIDs), serve as inclusion criteria in clinical trials, and support epidemiological surveys. Separate questionnaires were developed for adults, children/adolescents, and infants/toddlers. For the adult questionnaire, we first surveyed 1,162 adults without gastrointestinal disorders, and recommended the 90th percentile symptom frequency as the threshold for defining what is abnormal. Diagnostic questions were formulated and verified with clinical experts using a recursive process. The diagnostic sensitivity of the questionnaire was tested in 843 patients from 9 gastroenterology clinics, with a focus on clinical diagnoses of irritable bowel syndrome (IBS), functional constipation (FC), and functional dyspepsia (FD). Sensitivity was 62.7% for IBS, 54.7% for FD, and 32.2% for FC. Specificity, assessed in a population sample of 5,931 adults, was 97.1% for IBS, 93.3% for FD, and 93.6% for FC. Excess overlap among IBS, FC, and FD was a major contributor to reduced diagnostic sensitivity, and when overlap of IBS with FC was permitted, sensitivity for FC diagnosis increased to 73.2%. All questions were understandable to at least 90% of individuals, and Rome IV diagnoses were reproducible in ¾ of patients after one month. Validation of the pediatric questionnaires is ongoing.

Design of Treatment Trials for Functional Gastrointestinal Disorders

This article summarizes recent progress and regulatory guidance on design of trials to assess the efficacy of new therapies for functional gastrointestinal disorders (FGIDs). The double-masked, placebo-controlled, parallel-group design remains the accepted standard for evaluating treatment efficacy. A control group is essential, and a detailed description of the randomization process and concealed allocation method must be included in the study report. The control will most often be placebo, but for therapeutic procedures and for behavioral treatment trials, respectively, a sham procedure and control intervention with similar expectation of benefit, but lacking the treatment principle, are recommended. Investigators should be aware of, and attempt to minimize, expectancy effects (placebo, nocebo, precebo). The primary analysis should be based on the proportion of patients in each treatment arm who satisfy a treatment responder definition or a prespecified clinically meaningful change in a patient-reported outcome measure. Data analysis should use the intention-to-treat principle. Reporting of results should follow the Consolidated Standards for Reporting Trials guidelines and include secondary outcome measures to support or explain the primary outcome and an analysis of harms data. Trials should be registered in a public location before initiation and results should be published regardless of outcome.

Gastrointestinal problems in modern wars: clinical features and possible mechanisms.

Gastrointestinal problems are common during wars, and they have exerted significant adverse effects on the health of service members involved in warfare. The spectrum of digestive diseases has varied during wars of different eras. At the end of the 20th century, new frontiers of military medical research emerged due to the occurrence of high-tech wars such as the Gulf War and the Kosovo War, in which ground combat was no longer the primary method of field operations. The risk to the military personnel who face trauma has been greatly reduced, but disease and non-battle injuries (DNBIs) such as neuropsychological disorders and digestive diseases seemed to be increased. Data revealed that gastrointestinal symptoms such as constipation, diarrhea, dyspepsia, and noncardiac chest pain are common among military personnel during modern wars. In addition, a large number of deployed soldiers and veterans who participated in recent wars presented with chronic gastrointestinal complaints, which fulfilled with the Rome III criteria for functional gastrointestinal disorders (FGIDs). It was also noted that many veterans who returned from the Gulf War suffered not only from chronic digestive symptoms but also from neuropsychological dysfunction; however, they also showed symptoms of other systems. Presently, this broad range of unexplained symptoms is known as “Gulf War syndrome”. The mechanism that underlies Gulf War syndrome remains unclear, but many factors have been associated with this syndrome such as war trauma, stress, infections, immune dysfunction, radiological factors, anthrax vaccination and so on. Some have questioned if the diagnosis of FGIDs can be reached given the complexity of the military situation. As a result, further studies are needed to elucidate the pathogenesis of gastrointestinal disease among military personnel.

Hypnotherapy for Inflammatory Bowel Disease Across the Lifespan

Inflammatory bowel disease (IBD) is an autoimmune disorder characterized by lifelong relapsing gastrointestinal symptoms and associated with high rates of chronic pain, depression, and anxiety. In this review the author covers the existing literature including randomized controlled studies, open trials, and case reports as well as expert opinion in evaluating how hypnotherapy can be most beneficial in adolescents and adults with IBD. Hypnotherapy evidence for functional gastrointestinal disorders (FGIDs) is also reviewed as many of the gut-focused hypnotherapy (GHT) approaches used in IBD trials were developed for this latter population. Collectively, the strongest evidence of use of hypnotherapy is its association with reduced IBD-related inflammation and improved health-related quality of life with mixed results in terms of its effects on psychological and pain outcomes in adults with IBD. Studies of hypnotherapy for FGID symptoms show consistently more positive results. Post-operative hypnotherapy may also be helpful based on findings in other surgical samples. Adolescents with IBD have not been as systematically studied but small case series support the use of hypnotherapy to improve inflammation and pain. Future studies are needed to better delineate the specific brain-gut pathways which are most influenced by hypnotherapy in the IBD population and to investigate the longer-term course of the positive short-term findings.

Prevalence of Functional Gastrointestinal Disorders in Colombian School Children

To determine prevalence for functional gastrointestinal disorders (FGIDs) in Colombian school children using the Questionnaire on Pediatric Gastrointestinal Symptoms-Rome III Version (QPGS-III) and to determine possible risk factors. The QPGS-III was translated into Spanish then reverse translated by a team of bilingual physicians. Focus groups of Colombian children were conducted to assure understanding of the Spanish version. Children at 1 public school and 2 private schools in Pasto, Colombia were invited to participate in a prevalence study using the translated questionnaire. A total of 373 children (95 private school, 278 public school), with mean age 9.9 years completed the QPGS-III. Twenty-nine percent of children were diagnosed with FGIDs. FGIDs were more common in females (OR, 1.63; 95% CI, 1.04-2.56). Functional constipation (14%) was the most common FGID. Irritable bowel syndrome was the most common abdominal pain-related FGID (5.4%). Abdominal migraine (1%) and cyclic vomiting syndrome (0.3%) were the least common FGIDs. FGIDs are common in Colombian school children.

ROME III Consensus Guidelines Compares Imperfectly With a Naturalistic Classification of Individuals Attending Gastroenterology Outpatient Clinics

Background: The Rome consensus guidelines are formed by an expert panel that carefully considers the available evidence. Such criteria are however necessarily based on disparate pieces of research and designed to apply to the majority of patients. The extent to which the criteria represent groupings of symptoms as they occur within individuals has not been well described. Aims: To determine whether the Rome III expert consensus guidelines compare closely to groupings of individuals that would be obtained through a natural classification system Method: Outpatients attending gastroenterology outpatient clinics (n= 1,015) completed validated symptom questionnaires that allowed assessment of Rome III criteria for functional gastrointestinal disorders (FGIDs). Latent symptom dimensions were identified using non-orthogonal factor analysis. Clusters of individuals were formed using non-hierarchical cluster analysis. Results: Cluster analysis yielded six distinct clusters of individuals. The distinguishing symptoms of each cluster and their representation of Rome III criteria were: cluster 1: fewer and harder stools when pain begins and 72% IBS including 32% IBS-C and only 2% IBS-D, cluster 2 : early satiety, postprandial fullness and loss of appetite with 73% functional dyspepsia and 49% GERD compared with overall rates of 40% and 26% respectively, cluster 3 : frequent stool, loose/watery stool, accidental leakage along with frequent and severe pain and 34% IBS-D compared with 14% overall and 26% diarrhea compared with 12% overall, cluster 4: no unusually high symptom features and lower than average on pain features and lower than average on all Rome III criteria considered, including 0% IBS. The 5th and 6th clusters did not have symptom profiles that matched the pattern of Rome III prevalence observed. Conclusions: The Rome III criteria and symptom patterns occurring naturally in groups of patients show some overlap in four clusters of individuals that represent approximately 65% of individuals. In three of these clusters there was a meaningful coincidence of IBS-C and constipation, IBS-D and diarrhea, functional dyspepsia and PDS. The fourth cluster was represented by GERD and constipation. Whether the remaining 35% of patients represent a discordance between Rome III criteria and natural symptom patterns requires further investigation.

Differences in Gastrointestinal Symptoms According to Gender in Rome II Positive IBS and Dyspepsia in a Latin American Population

Irritable bowel syndrome (IBS), constipation, and bloating are more prevalent in women than men, but gender differences associated with dyspepsia are inconsistent.The aim of this study was to determine gender differences in the prevalence of symptoms diagnostic for functional gastrointestinal disorders (FGIDs) in subjects with IBS and dyspepsia, as well as in controls in Mexico. A database of 1,021 subjects (61% women) who completed the Rome II Modular Questionnaire (RIIMQ) in Spanish Mexico was analyzed. Gender differences in the frequency of all symptoms included in the RIIMQ between those fulfilling criteria for IBS (28.9%), dyspepsia (4.0%) and controls without any FGIDs (38.2%) were studied. Subjects fulfilling criteria only for other FGIDs were excluded. There were higher proportions of women with IBS (67.8%) and dyspepsia (85.4%) compared with the control group (55.9%) (P<0.001). In IBS, women more frequently reported changes in the number of bowel movements (BMs) associated with the onset of abdominal discomfort/pain, fewer than three BMs/week and abdominal fullness/bloating/swelling than men. Men with IBS more frequently reported swallowing air to belch and abdominal pain that improved after a BM than women. In controls, burping and hard or lumpy stools were both more frequent in men. In Mexico, gender differences in FGIDs exist, with both IBS and dyspepsia being more common in women than men. In IBS, symptoms related to constipation and bloating were more common in women, but the dyspepsia group was too small to draw any conclusions. Finally, this is the first study to report that belching is more common in men than women controls not fulfilling criteria for any FGID.

Neuronal correlates in the modulation of placebo analgesia in experimentally-induced esophageal pain: A 3T-fMRI study

Visceral pain/discomfort is the cardinal complaints and treatment targets for functional gastrointestinal disorders (FGID). However, effective treatment for such pain is limited and often associated with high placebo effects. The mechanisms of placebo effects in visceral pain are unclear. We used functional neuroimaging to study the central representations of the placebo effect and its anticipation during esophageal pain in healthy adults. Fourteen subjects were enrolled. Pain extent, psychophysical inventories [Pain Catastrophizing Scale (PAS), visual analogue scale (VAS) and short-form McGill questionnaire], and brain activity upon placebo intervention and upon anticipation were assessed in response to esophageal balloon distension. Large reductions of pain extent, VAS rating, short-form McGill questionnaire scores, and brain activity in the visceral pain matrix [thalamus, somatosensory cortices, insula, prefrontal cortex (PFC), anterior cingulate cortex] were observed upon placebo treatment. The aforementioned brain areas and the bilateral amygdala were significantly correlated with decreased pain extent and VAS in response to placebo. The ventral lateral PFC (VLPFC) was associated with increased activity during anticipation of visceral pain. PAS cannot predict the placebo effect in visceral pain. In conclusion, pronounced placebo analgesia was coupled with prominent changes of brain activity in visceral pain matrix, which are thus likely involved in high placebo efficacy during the treatment of visceral pain in FGID. VLPFC activation during the anticipation of placebo analgesia suggests top-down control in the modulation of pain experience.

Do We Know What Patients Want? The Doctor-Patient Communication Gap in Functional Gastrointestinal Disorders

Understanding patients' expectations at initial consultation for functional gastrointestinal disorders (FGIDs) might influence future health care utilization. Ideally, patients and doctors would have a common understanding of the issues involved. We sought to investigate this with matched questionnaires. Patients' needs/expectations/understanding were compared with gastroenterologists' and general practitioners' awareness of these. Patients were followed up to investigate satisfaction with and outcomes of specialist consultation. Specialists underestimated the number and severity of patients' symptoms (in 43% and 41%, respectively), and patients and specialists had quite discordant views on what treatment would best suit their symptoms. Strikingly, only 1 of 13 patients available for follow-up agreed with or accepted the functional diagnosis, despite all being diagnosed by a specialist as having an FGID. In FGIDs there is a communication gap between patients and gastroenterologists. Importantly, at follow-up, patients do not acknowledge their FGID diagnosis. This communication gap and lack of acceptance of a functional diagnosis are likely to influence future management and health care utilization.

Efficacy of Probiotics and Nutrients in Functional Gastrointestinal Disorders: A Preliminary Clinical Trial

The purpose of this study was to evaluate the efficacy and safety of commonly used probiotics and nutrients available for functional gastrointestinal disorders (FGID). Five different combinations of probiotics and nutrients, or placebo, were taken daily over 12 weeks. In this randomized controlled clinical trial, men and women 21 to 72 years of age with FGID symptoms of indigestion, bloating, and abdominal discomfort were assigned to one of six groups, 12 patients per group. Gastrointestinal Quality of Life Index (GIQLI) and visual analogue scale (VAS) for GI symptoms, SF-36, lactulose and mannitol test (LMT), and urine indican levels were evaluated. GIQLI, VAS scores, and LMT did not change significantly (P > 0.05). There were clinically notable improvements in two of the combination formulations. While the nonsignificant improvements in GI symptoms could suggest that combination probiotics and nutrients may be beneficial in conditions such as FGID, no conclusive evidence was found in this pilot trial. Further investigations to explore the findings are discussed.

Childhood Functional Gastrointestinal Disorders: Child/Adolescent

The Rome II pediatric criteria for functional gastrointestinal disorders (FGIDs) were defined in 1999 to be used as diagnostic tools and to advance empirical research. In this document, the Rome III Committee aimed to update and revise the pediatric criteria. The decision-making process to define Rome III criteria for children aged 4-18 years consisted of arriving at a consensus based on clinical experience and review of the literature. Whenever possible, changes in the criteria were evidence based. Otherwise, clinical experience was used when deemed necessary. Few publications addressing Rome II criteria were available to guide the committee. The clinical entities addressed include (1) cyclic vomiting syndrome, rumination, and aerophagia; 2) abdominal pain-related FGIDs including functional dyspepsia, irritable bowel syndrome, abdominal migraine, and functional abdominal pain; and (3) functional constipation and non-retentive fecal incontinence. Adolescent rumination and functional constipation are newly defined for this age group, and the previously designated functional fecal retention is now included in functional constipation. Other notable changes from Rome II to Rome III criteria include the decrease from 3 to 2 months in required symptom duration for noncyclic disorders and the modification of the criteria for functional abdominal pain. The Rome III child and adolescent criteria represent an evolution from Rome II and should prove useful for both clinicians and researchers dealing with childhood FGIDs. The future availability of additional evidence-based data will likely continue to modify pediatric criteria for FGIDs.

Design of Treatment Trials for Functional Gastrointestinal Disorders

This document addresses the design of trials to assess the efficacy of new treatments for functional gastrointestinal disorders (FGID), emphasizing trials in irritable bowel syndrome and dyspepsia, because most research has been undertaken in these conditions. The double-blind, randomized, placebo-controlled, parallel group trial remains the preferred design. Randomized withdrawal designs, although encouraged by the European Agency for the Evaluation of Medicinal Products, have the same potential disadvantages as a crossover design, including carryover effects, unmasking (unblinding), and overestimation of the potential benefit for clinical practice. Innovative trial designs that evaluate intermittent (on demand) treatment are likely to become more common in the future. Investigators should include as broad a spectrum of patients as possible and should report recruitment strategies, inclusion/exclusion criteria, and attrition data. The primary analysis should be based on the proportion of patients in each treatment arm who satisfy an a priori treatment responder definition, or a prespecified clinically meaningful change in a patient-reported symptom improvement measure. Such measures of improvement are psychometrically validated subjective global assessments or a change from baseline in a validated symptom severity questionnaire. It is unethical to change the responder definition after a trial begins. Data analysis should address all patients enrolled, using an intention-to-treat principle. Reporting of results should follow the Consolidated Standards for Reporting Trials guidelines and include an analysis of harms data and secondary outcome measures to support or explain the primary outcome. Trials should be registered in a public location, prior to initiation, and should be published even if the results are negative or inconclusive.

Validation of the Pediatric Rome II Criteria for Functional Gastrointestinal Disorders Using the Questionnaire on Pediatric Gastrointestinal Symptoms

To validate the pediatric Rome II criteria for functional gastrointestinal disorders (FGIDs) using the Questionnaire on Pediatric Gastrointestinal Symptoms (QPGS). Subjects were 315 consecutive new patients, 4 to 18 years of age, seen in a tertiary care clinic and classified by pediatric gastroenterologists as having a functional problem. Patients and parents separately completed the QPGS before medical consultation. Diagnoses were derived using computer algorithms reflecting the Rome II criteria for pediatric FGIDs. Convergent validity was assessed by prevalence of diagnoses and internal validity using factor analysis to confirm symptom clusters of the criteria. Separate analyses were performed for 4 to 9 and 10 to 18 year olds, and for diagnoses based on parent and child reports. In both age groups, the most prevalent diagnoses were irritable bowel syndrome (IBS) (22.0%, 35.5%), functional constipation (19.0%, 15.2%), and functional dyspepsia (FD) (13.6%, 10.1%). Parent-child concordance on diagnoses was generally poor. Factor analyses supported the internal validity of FD and of IBS symptoms except for relief with defecation. Although functional abdominal pain syndrome and abdominal migraine occurred rarely, symptom clustering within each diagnosis supports their validity. Among patients with abdominal pain, duration was of at least 3 months in most, and pain was of long duration and severe in at least one third. More than half of patients classified as having a functional problem met at least one pediatric Rome II diagnosis for FGIDs. This study offers initial support for the validity of several of the criteria.

Childhood functional gastrointestinal disorders

This is the first attempt at defining criteria for functional gastrointestinal disorders (FGIDs) in infancy, childhood, and adolescence. The decision-making process was as for adults and consisted of arriving at...