A diet low in FODMAPs reduces symptoms in patients with irritable bowel syndrome and a probiotic restores bifidobacterium species: a randomized controlled trial
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Background & aims Dietary restriction of fermentable carbohydrates (a low FODMAP diet) has been reported to reduce symptoms in some patients with irritable bowel syndrome (IBS). We performed a randomized, placebo-controlled study to determine its effects on symptoms and the fecal microbiota in patients with IBS.Methods We performed a 2×2 factorial trial of 104 patients with IBS (18-65 years old), based on the Rome III criteria, at 2 hospitals in the United Kingdom. Patients were randomly assigned (blinded) to groups given counselling to follow a sham diet or diet low in FODMAPs for 4 weeks, along with a placebo or multistrain probiotic formulation, resulting in 4 groups (27 receiving sham diet/placebo, 26 receiving sham diet/probiotic, 24 receiving low FODMAP diet /placebo, and 27 receiving low FODMAP diet/probiotic). The sham diet restricted a similar number of staple and non-staple foods as the low FODMAP diet; the diets had similar degrees of difficulty to follow. Dietary counselling was given to patients in all groups and data on foods eaten and compliance were collected. The incidence and severity of 15 gastrointestinal symptoms and overall symptoms were measured daily for 7 days before the study period; along with stool frequency and consistency. At baseline, global and individual symptoms were measured, along with generic and disease-specific health-related quality of life, using standard scoring systems. All data were collected again at 4 weeks, and patients answered questions about adequate symptom relief. Fecal samples were collected at baseline and after 4 weeks and analyzed by quantitative PCR and 16S rRNA sequencing. The co-primary endpoints were adequate relief of symptoms and stool Bifidobacterium species abundance at 4 weeks.Results There was no significant interaction between the interventions in adequate relief of symptoms (P = .52) or Bifidobacterium species (P = .68). In the intention-to-treat analysis, a higher proportion of patients in the low FODMAP diet had adequate symptom relief (57%) than in the sham diet group (38%), although the difference was not statistically significant (P = .051). In the per-protocol analysis, a significantly higher proportion of patients on the low FODMAP diet had adequate symptom relief (61%) than in the sham diet group (39%) (P = .042). Total mean IBS-Severity Scoring System score was significantly lower for patients on the low FODMAP diet (173 ± 95) than the sham diet (224 ± 89) (P = .001), but not different between those given probiotic (207 ± 98) or placebo (192 ± 93) (P = .721) Abundance of Bifidobacterium species was lower in fecal samples from patients on the low FODMAP diet (8.8 rRNA genes/g) than patients on the sham diet (9.2 rRNA genes/g) (P = .008), but higher in patients given probiotic (9.1 rRNA genes/g) than patients given placebo (8.8 rRNA genes/g) (P = .019). There was no effect of the low FODMAP diet on microbiota diversity in fecal samples.Conclusions In a placebo-controlled study of patients with IBS, a low FODMAP diet associates with adequate symptom relief and significantly reduced symptom scores compared with placebo. It is not clear whether changes resulted from collective FODMAP restriction or removal of a single component, such as lactose. Co-administration of the multistrain probiotic increased numbers of Bifidobacterium species, compared with placebo, and might be given to restore these bacteria to patients on a low FODMAP diet. Trial registration no: ISRCTN02275221.
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The long-term effects on the gut microbiome of dietary interventions with reported benefit in IBS, such as psyllium fiber and low FODMAP diet, remain unknown.
“the long term consequences of current dietary interventions with reported benefit in IBS, such as supplementation with psyllium fiber and the low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet31, 32, on the gut microbiome remain to be seen.”
From The gut Microbiome in adult and pediatric functional gastrointestinal disorders (2019) · cites this paper as [32]
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“, 80% of nutrient/placebo supplements consumed (37) or 95% of study diet consumed (41)), for which there is no established gold standard or a statistically and nutritionally significant change in intake of the dietary component.”
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Self-citation
- Authors
- Staudacher, H. M., Lomer, M. C. E., Farquharson, F. M., Louis, P., Fava, F., Franciosi, E., Scholz, M., Tuohy, K. M., Lindsay, J. O., Irving, P. M., & Whelan, K.
- Affiliations
- King's College London (GB)
- University of Aberdeen (GB)
- Fondazione Edmund Mach (IT)
- Queen Mary University of London (GB)
- Corresponding author
- Whelan, Kevin
- ORCID
- Venue
- Gastroenterology
- Publisher
- Elsevier BV
- Published
- 2017-10
- Volume
- 153
- Issue
- 4
- Pages
- 936-947
- ISSN
- 0016-5085 (ISSN-L)
- OpenAlex
- W2625582958
- Cited by
- 430
- References
- 40
- Citations by year
- 2026: 27 · 2025: 37 · 2024: 40 · 2023: 28 · 2022: 54 · 2021: 69 · 2020: 53 · 2019: 58 · 2018: 53 · 2017: 11
- FWCI
- 50.27
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Gastroenterology (publishedVersion)
- PubMed (publishedVersion)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- Own your potential (DEAKIN) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- Research Portal (King's College London) (submittedVersion, other-oa)
- CINECA IRIS Institutional Research Information System (Fondazione Edmund Mach) (submittedVersion)
- Queen Mary Research Online (Queen Mary University of London) (submittedVersion, cc-by-nc-nd)
- Funders
- Rural and Environment Science and Analytical Services Division
- Topics
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Gut microbiota and health
- Life Sciences › Agricultural and Biological Sciences › Food Science › Probiotics and Fermented Foods
- Keywords
- irritable bowel syndrome, low FODMAP diet, probiotics, Bifidobacterium, gut microbiota, dietary restriction, gastrointestinal symptoms, symptom relief, health-related quality of life, nutrition counseling, stool consistency, stool frequency, Rome III criteria, 16S rRNA gene sequencing, real-time PCR, dietary adherence
- MeSH terms
- Gastrointestinal Microbiome, Adult, Bifidobacterium, Combined Modality Therapy, Dietary Carbohydrates, Feces, Female, Fermentation, Humans, Intestines, London, Male, Middle Aged, Quality of Life, Surveys and Questionnaires, Remission Induction, Severity of Illness Index, Time Factors, Treatment Outcome, Probiotics, Ribotyping, Irritable Bowel Syndrome, Diet, Carbohydrate-Restricted, Young Adult
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