Diet Low in FODMAPs Reduces Symptoms in Patients with Irritable Bowel Syndrome and Probiotic Restores Bifidobacterium Species: a Randomized Controlled Trial

HM Staudacher, MCE Lomer, FM Farquharson, P Louis, F. Fava, E Franciosi , M Scholz, KM Tuohy, J O Lindsay, PM Irving, K. Whelan

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Abstract

Background & AimsDietary 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.
MethodsWe performed a 2x2 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 probiotic supplement (VSL#3), 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.
ResultsThere 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%) vs 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=.043). 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.
ConclusionsIn 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 probiotic VSL#3 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.
Original languageEnglish
Pages (from-to)936-947
Number of pages12
JournalGastroenterology
Volume153
Issue number4
Early online date15 Jun 2017
DOIs
Publication statusPublished - Oct 2017

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Bifidobacterium
Irritable Bowel Syndrome
Probiotics
Randomized Controlled Trials
Diet
Placebos
rRNA Genes
Microbiota
Counseling
Food

Keywords

  • food sensitivity
  • fructans
  • galacto-oligosaccharides
  • lactose

Cite this

Diet Low in FODMAPs Reduces Symptoms in Patients with Irritable Bowel Syndrome and Probiotic Restores Bifidobacterium Species : a Randomized Controlled Trial . / Staudacher, HM; Lomer, MCE; Farquharson, FM; Louis, P; Fava, F.; Franciosi , E; Scholz, M; Tuohy, KM; Lindsay, J O ; Irving, PM; Whelan, K.

In: Gastroenterology, Vol. 153, No. 4, 10.2017, p. 936-947.

Research output: Contribution to journalArticle

Staudacher, HM, Lomer, MCE, Farquharson, FM, Louis, P, Fava, F, Franciosi , E, Scholz, M, Tuohy, KM, Lindsay, JO, Irving, PM & Whelan, K 2017, 'Diet Low in FODMAPs Reduces Symptoms in Patients with Irritable Bowel Syndrome and Probiotic Restores Bifidobacterium Species: a Randomized Controlled Trial ', Gastroenterology, vol. 153, no. 4, pp. 936-947. https://doi.org/10.1053/j.gastro.2017.06.010
Staudacher, HM ; Lomer, MCE ; Farquharson, FM ; Louis, P ; Fava, F. ; Franciosi , E ; Scholz, M ; Tuohy, KM ; Lindsay, J O ; Irving, PM ; Whelan, K. / Diet Low in FODMAPs Reduces Symptoms in Patients with Irritable Bowel Syndrome and Probiotic Restores Bifidobacterium Species : a Randomized Controlled Trial . In: Gastroenterology. 2017 ; Vol. 153, No. 4. pp. 936-947.
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abstract = "Background & AimsDietary 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.MethodsWe performed a 2x2 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 probiotic supplement (VSL#3), 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.ResultsThere 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{\%}) vs 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=.043). 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.ConclusionsIn 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 probiotic VSL#3 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.",
keywords = "food sensitivity, fructans, galacto-oligosaccharides, lactose",
author = "HM Staudacher and MCE Lomer and FM Farquharson and P Louis and F. Fava and E Franciosi and M Scholz and KM Tuohy and Lindsay, {J O} and PM Irving and K. Whelan",
note = "National Institute for Health Research The National Institute for Health Research funded the study and had no role in the study design, data collection, data analysis, data interpretation or writing of the manuscript. FMF and PL receive financial support from the Scottish Government Rural and Environmental Sciences and Analytical Services (RESAS). The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.",
year = "2017",
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}

TY - JOUR

T1 - Diet Low in FODMAPs Reduces Symptoms in Patients with Irritable Bowel Syndrome and Probiotic Restores Bifidobacterium Species

T2 - a Randomized Controlled Trial

AU - Staudacher, HM

AU - Lomer, MCE

AU - Farquharson, FM

AU - Louis, P

AU - Fava, F.

AU - Franciosi , E

AU - Scholz, M

AU - Tuohy, KM

AU - Lindsay, J O

AU - Irving, PM

AU - Whelan, K.

N1 - National Institute for Health Research The National Institute for Health Research funded the study and had no role in the study design, data collection, data analysis, data interpretation or writing of the manuscript. FMF and PL receive financial support from the Scottish Government Rural and Environmental Sciences and Analytical Services (RESAS). The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.

PY - 2017/10

Y1 - 2017/10

N2 - Background & AimsDietary 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.MethodsWe performed a 2x2 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 probiotic supplement (VSL#3), 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.ResultsThere 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%) vs 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=.043). 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.ConclusionsIn 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 probiotic VSL#3 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.

AB - Background & AimsDietary 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.MethodsWe performed a 2x2 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 probiotic supplement (VSL#3), 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.ResultsThere 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%) vs 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=.043). 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.ConclusionsIn 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 probiotic VSL#3 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.

KW - food sensitivity

KW - fructans

KW - galacto-oligosaccharides

KW - lactose

U2 - 10.1053/j.gastro.2017.06.010

DO - 10.1053/j.gastro.2017.06.010

M3 - Article

VL - 153

SP - 936

EP - 947

JO - Gastroenterology

JF - Gastroenterology

SN - 0016-5085

IS - 4

ER -