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A Diet Low in FODMAPs Reduces Symptoms in Patients With Irritable Bowel Syndrome and A Probiotic Restores Bifidobacterium Species: A Randomized Controlled Trial.
Gastroenterology 2017; 153(4):936-947G

Abstract

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.

Authors+Show Affiliations

Faculty of Life Sciences and Medicine, Diabetes and Nutritional Sciences Division, King's College London, London, United Kingdom.Faculty of Life Sciences and Medicine, Diabetes and Nutritional Sciences Division, King's College London, London, United Kingdom; Department of Gastroenterology, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom; Department of Nutrition and Dietetics, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.The Rowett Institute, University of Aberdeen, Gut Health Group, Aberdeen, United Kingdom.The Rowett Institute, University of Aberdeen, Gut Health Group, Aberdeen, United Kingdom.Research and Innovation Centre, Department of Food Quality and Nutrition, Nutrition and Nutrigenomics Group, Fondazione Edmund Mach, Trento, Italy.Research and Innovation Centre, Department of Food Quality and Nutrition, Nutrition and Nutrigenomics Group, Fondazione Edmund Mach, Trento, Italy.Research and Innovation Centre, Department of Food Quality and Nutrition, Nutrition and Nutrigenomics Group, Fondazione Edmund Mach, Trento, Italy.Research and Innovation Centre, Department of Food Quality and Nutrition, Nutrition and Nutrigenomics Group, Fondazione Edmund Mach, Trento, Italy.Blizard Institute, Queen Mary University of London, Centre for Immunobiology, London, United Kingdom; Barts Health NHS Trust, London, United Kingdom.Faculty of Life Sciences and Medicine, Diabetes and Nutritional Sciences Division, King's College London, London, United Kingdom; Department of Gastroenterology, Guys and St Thomas' NHS Foundation Trust, London, United Kingdom.Faculty of Life Sciences and Medicine, Diabetes and Nutritional Sciences Division, King's College London, London, United Kingdom. Electronic address: kevin.whelan@kcl.ac.uk.

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28625832

Citation

Staudacher, Heidi Maria, et al. "A Diet Low in FODMAPs Reduces Symptoms in Patients With Irritable Bowel Syndrome and a Probiotic Restores Bifidobacterium Species: a Randomized Controlled Trial." Gastroenterology, vol. 153, no. 4, 2017, pp. 936-947.
Staudacher HM, Lomer MCE, Farquharson FM, et al. A Diet Low in FODMAPs Reduces Symptoms in Patients With Irritable Bowel Syndrome and A Probiotic Restores Bifidobacterium Species: A Randomized Controlled Trial. Gastroenterology. 2017;153(4):936-947.
Staudacher, H. M., Lomer, M. C. E., Farquharson, F. M., Louis, P., Fava, F., Franciosi, E., ... Whelan, K. (2017). A Diet Low in FODMAPs Reduces Symptoms in Patients With Irritable Bowel Syndrome and A Probiotic Restores Bifidobacterium Species: A Randomized Controlled Trial. Gastroenterology, 153(4), pp. 936-947. doi:10.1053/j.gastro.2017.06.010.
Staudacher HM, et al. A Diet Low in FODMAPs Reduces Symptoms in Patients With Irritable Bowel Syndrome and a Probiotic Restores Bifidobacterium Species: a Randomized Controlled Trial. Gastroenterology. 2017;153(4):936-947. PubMed PMID: 28625832.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Diet Low in FODMAPs Reduces Symptoms in Patients With Irritable Bowel Syndrome and A Probiotic Restores Bifidobacterium Species: A Randomized Controlled Trial. AU - Staudacher,Heidi Maria, AU - Lomer,Miranda C E, AU - Farquharson,Freda M, AU - Louis,Petra, AU - Fava,Francesca, AU - Franciosi,Elena, AU - Scholz,Matthias, AU - Tuohy,Kieran M, AU - Lindsay,James O, AU - Irving,Peter M, AU - Whelan,Kevin, Y1 - 2017/06/15/ PY - 2016/11/24/received PY - 2017/05/17/revised PY - 2017/06/09/accepted PY - 2017/6/20/pubmed PY - 2017/10/17/medline PY - 2017/6/20/entrez KW - Food Sensitivity KW - Fructans KW - Galacto-oligosaccharides KW - Lactose SP - 936 EP - 947 JF - Gastroenterology JO - Gastroenterology VL - 153 IS - 4 N2 - 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. SN - 1528-0012 UR - https://www.unboundmedicine.com/medline/citation/28625832/A_Diet_Low_in_FODMAPs_Reduces_Symptoms_in_Patients_With_Irritable_Bowel_Syndrome_and_A_Probiotic_Restores_Bifidobacterium_Species:_A_Randomized_Controlled_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(17)35744-X DB - PRIME DP - Unbound Medicine ER -