Efficacy and Findings of a Blinded Randomized Reintroduction Phase for the Low FODMAP Diet in Irritable Bowel Syndrome.
Study Goal
The researchers aimed to objectively identify FODMAP triggers through a blinded reintroduction phase and evaluate the impact on symptoms, quality of life, and psychosocial comorbidities in IBS patients.
Results Summary
The low-FODMAP diet significantly improved IBS symptoms (80% responders), with fructans and mannitol being the most prevalent triggers. Symptom recurrence occurred in 85% of FODMAP reintroductions, with specific timing for symptom onset depending on the FODMAP type.
Population
117 patients with irritable bowel syndrome (IBS) from a tertiary-care setting.
Effective Dosage
Not specified (FODMAP powders used in reintroduction phase).
Duration
6-week elimination period followed by a 9-week reintroduction phase.
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
low fermentable oligo-, di-, monosaccharides and polyols (FODMAP) diet | neutral | efficacy in irritable bowel syndrome (IBS) | patients with IBS | - | is well established | #1 |
low FODMAP diet | decrease | IBS symptom severity score (IBS-SSS) | 117 recruited patients with IBS | 150 ± 116 vs 301 ± 97 | improved significantly | #2 |
low FODMAP diet | decrease | symptoms | tertiary-care IBS patients | - | significant benefit | #3 |
FODMAP powders (fructans, fructose, galacto-oligosaccharides, lactose, mannitol, sorbitol) | increase | symptoms | responders to a 6-week low FODMAP diet | 85% of the FODMAP powders | triggered symptom recurrence | #4 |
FODMAP powders | increase | symptoms | responders to a 6-week low FODMAP diet | average of 2.5 ± 2 FODMAPs/patient | triggered symptom recurrence | #5 |
fructans | increase | symptom recurrence | responders to a 6-week low FODMAP diet | 56% | most prevalent trigger | #6 |
mannitol | increase | symptom recurrence | responders to a 6-week low FODMAP diet | 54% | most prevalent trigger | #7 |
galacto-oligosaccharides | increase | symptom recurrence | responders to a 6-week low FODMAP diet | 35% | trigger | #8 |
lactose | increase | symptom recurrence | responders to a 6-week low FODMAP diet | 28% | trigger | #9 |
fructose | increase | symptom recurrence | responders to a 6-week low FODMAP diet | 27% | trigger | #10 |
sorbitol | increase | symptom recurrence | responders to a 6-week low FODMAP diet | 23% | trigger | #11 |
glucose | increase | symptom recurrence | responders to a 6-week low FODMAP diet | 26% | trigger | #12 |
sorbitol/mannitol | increase | abdominal pain | responders to a 6-week low FODMAP diet | day 1 | significant increase | #13 |
fructans/galacto-oligosaccharides | increase | abdominal pain | responders to a 6-week low FODMAP diet | day 2 | significant increase | #14 |
lactose | increase | abdominal pain | responders to a 6-week low FODMAP diet | day 3 | significant increase | #15 |
BACKGROUND & AIMS: The efficacy of a low fermentable oligo-, di-, monosaccharides and polyols (FODMAP) diet in irritable bowel syndrome (IBS) is well established. After the elimination period, a reintroduction phase aims to identify triggers. We studied the impact of a blinded reintroduction using FODMAP powders to objectively identify triggers and evaluated the effect on symptoms, quality of life, and psychosocial comorbidities. METHODS: Responders to a 6-week low FODMAP diet, defined by a drop in IBS symptom severity score (IBS-SSS) compared with baseline, entered a 9-week blinded randomized reintroduction phase with 6 FODMAP powders (fructans, fructose, galacto-oligosaccharides, lactose, mannitol, sorbitol) or control (glucose). A rise in IBS-SSS (≥50 points) defined a FODMAP trigger. Patients completed daily symptom diaries and questionnaires for quality of life and psychosocial comorbidities. RESULTS: In 117 recruited patients with IBS, IBS-SSS improved significantly after the elimination period compared with baseline (150 ± 116 vs 301 ± 97, P < .0001, 80% responders). Symptom recurrence was triggered in 85% of the FODMAP powders, by an average of 2.5 ± 2 FODMAPs/patient. The most prevalent triggers were fructans (56%) and mannitol (54%), followed by galacto-oligosaccharides, lactose, fructose, sorbitol, and glucose (respectively 35%, 28%, 27%, 23%, and 26%) with a significant increase in abdominal pain at day 1 for sorbitol/mannitol, day 2 for fructans/galacto-oligosaccharides, and day 3 for lactose. CONCLUSION: We confirmed the significant benefit of the low FODMAP diet in tertiary-care IBS. A blinded reintroduction revealed a personalized pattern of symptom recurrence, with fructans and mannitol as the most prevalent, and allows the most objective identification of individual FODMAP triggers. Ethical commission University hospital of Leuven reference number: s63629; Clinicaltrials.gov number: NCT04373304.