A Randomized Controlled Trial Comparing the Low FODMAP Diet vs. Modified NICE Guidelines in US Adults with IBS-D.
Study Goal
The researchers aimed to compare the efficacy of a low FODMAP diet versus a modified NICE guidelines diet (mNICE) in relieving IBS-D symptoms, particularly focusing on overall and individual symptom improvement.
Results Summary
The low FODMAP diet showed a higher proportion of abdominal pain responders (51% vs. 23%) and greater reductions in symptoms like bloating, stool consistency, frequency, and urgency compared to the mNICE diet, though the primary endpoint (adequate relief) did not reach statistical significance.
Population
US adults with IBS-D (Rome III criteria), predominantly women (65 out of 92), median age 42.6 years.
Effective Dosage
Not specified (dietary intervention).
Duration
4 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
low FODMAP diet | decrease | IBS-D symptoms | US adults with IBS and diarrhea (IBS-D) | 52% | reported adequate relief | #1 |
diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) | decrease | IBS-D symptoms | US adults with IBS and diarrhea (IBS-D) | 41% | reported adequate relief | #2 |
low FODMAP diet | increase | abdominal pain responders | US adults with IBS and diarrhea (IBS-D) | 51% vs. 23% | resulted in a higher proportion of | #3 |
diet based upon modified National Institute for Health and Care Excellence guidelines (mNICE) | increase | abdominal pain responders | US adults with IBS and diarrhea (IBS-D) | 23% vs. 51% | resulted in a lower proportion of | #4 |
low FODMAP diet | decrease | abdominal pain | US adults with IBS and diarrhea (IBS-D) | - | led to greater reductions in average daily scores of | #5 |
low FODMAP diet | decrease | bloating | US adults with IBS and diarrhea (IBS-D) | - | led to greater reductions in average daily scores of | #6 |
low FODMAP diet | decrease | consistency | US adults with IBS and diarrhea (IBS-D) | - | led to greater reductions in average daily scores of | #7 |
low FODMAP diet | decrease | frequency | US adults with IBS and diarrhea (IBS-D) | - | led to greater reductions in average daily scores of | #8 |
low FODMAP diet | decrease | urgency | US adults with IBS and diarrhea (IBS-D) | - | led to greater reductions in average daily scores of | #9 |
low FODMAP diet | increase | individual IBS symptoms, particularly pain and bloating | US adults with IBS and diarrhea (IBS-D) | - | led to significantly greater improvement in | #10 |
OBJECTIVES: 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.