title: A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D.
abstract: OBJECTIVE
  There has been an increasing interest in the role of fermentable oligo-, di-, and monosaccharides and polyols (FODMAPs) in irritable bowel syndrome (IBS). We report results from the first randomized controlled trial of the low FODMAP diet in US adults with IBS and diarrhea (IBS-D). The objectives were to compare the efficacy of the low FODMAP diet vs. a diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) on overall and individual symptoms in IBS-D patients.
  
  
  METHODS
  This was a single-center, randomized-controlled trial of adult patients with IBS-D (Rome III) which compared 2 diet interventions. After a 2-week screening period, eligible patients were randomized to a low FODMAP or mNICE diet for 4 weeks. The primary end point was the proportion of patients reporting adequate relief of IBS-D symptoms ≥50% of intervention weeks 3-4. Secondary outcomes included a composite end point which required response in both abdominal pain (≥30% reduction in mean daily pain score compared with baseline) and stool consistency (decrease in mean daily Bristol Stool Form of ≥1 compared with baseline), abdominal pain and stool consistency responders, and other key individual IBS symptoms assessed using daily questionnaires.
  
  
  RESULTS
  After screening, 92 subjects (65 women, median age 42.6 years) were randomized. Eighty-four patients completed the study (45 low FODMAP, 39 mNICE). Baseline demographics, symptom severity, and nutrient intake were similar between groups. Fifty-two percent of the low FODMAP vs. 41% of the mNICE group reported adequate relief of their IBS-D symptoms (P=0.31). Though there was no significant difference in the proportion of composite end point responders (P=0.13), the low FODMAP diet resulted in a higher proportion of abdominal pain responders compared with the mNICE group (51% vs. 23%, P=0.008). Compared with baseline scores, the low FODMAP diet led to greater reductions in average daily scores of abdominal pain, bloating, consistency, frequency, and urgency than the mNICE diet.
  
  
  CONCLUSIONS
  In this US trial, 40-50% of patients reported adequate relief of their IBS-D symptoms with the low FODMAP diet or a diet based on modified NICE guidelines. The low FODMAP diet led to significantly greater improvement in individual IBS symptoms, particularly pain and bloating, compared with the mNICE diet.
authors.affiliation: Division of Gastroenterology, University of Michigan Health System, Ann Arbor, Michigan, USA.
authors.forename: Shanti L
authors.initials: SL
authors.lastname: Eswaran
authors.affiliation: Division of Gastroenterology, University of Michigan Health System, Ann Arbor, Michigan, USA.
authors.forename: William D
authors.initials: WD
authors.lastname: Chey
authors.affiliation: University of Michigan Health System, Michigan Clinical Research Unit and Nutrition Obesity Research Center, Ann Arbor, Michigan, USA.
authors.forename: Theresa
authors.initials: T
authors.lastname: Han-Markey
authors.affiliation: University of Michigan Health System, Nutrition Obesity Research Center, Ann Arbor, Michigan, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Ball
authors.affiliation: Division of Gastroenterology, University of Michigan Health System, Ann Arbor, Michigan, USA.
authors.forename: Kenya
authors.initials: K
authors.lastname: Jackson
mesh_terms: D015746:Abdominal Pain / Q000209:etiology; D000328:Adult; D000368:Aged; D003967:Diarrhea / Q000178:diet therapy* / Q000209:etiology; D004187:Disaccharides; D005260:Female; D005285:Fermentation; D005632:Fructose; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000178:diet therapy*; D007785:Lactose; D008297:Male; D008875:Middle Aged; D009005:Monosaccharides; D009844:Oligosaccharides; D011108:Polymers; D017410:Practice Guidelines as Topic; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004187:Disaccharides; D009005:Monosaccharides; D009844:Oligosaccharides; D011108:Polymers; C024617:polyol; D005632:Fructose; D007785:Lactose