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Abstract
Gut-brain dysregulation and microbiome dysfunction are central to the pathogenesis of irritable bowel syndrome (IBS). Depressive and anxiety symptoms are highly prevalent and contribute to disease burden but are not commonly addressed in practice. The low FODMAP diet is efficacious for managing gastrointestinal symptoms but may not be appropriate in those with psychological comorbidity due to its complexity. A Mediterranean diet (MD), rich in vegetables, pulses, wholegrains and olive oil, has potential benefit in IBS as it leads to positive shifts in microbiome composition and function, and RCTs have demonstrated antidepressant effects. The TANDIM trial aimed to assess the feasibility of a MD in patients with IBS and psychological comorbidity.
Adults aged 18-65 years with Rome IV IBS and mild or moderate anxiety and/or depressive symptoms were recruited to a 6-week RCT. Significant medical or mental health conditions (e.g. inflammatory bowel disease, bipolar disorder) and recent change in IBS or psychotropic treatment were excluded. Patients were randomised to MD advice from a dietitian or advice to continue habitual diet. Diet adherence was measured using a Mediterranean diet adherence screener (MEDAS). Gastrointestinal symptoms (IBS-SSS), psychological symptoms (HADS) and quality of life (IBS-QOL) data were collected at baseline and follow up. Stool samples were collected for metagenomic sequencing. Data were analysed on an intention-to-treat basis. For continuous variables, analysis of covariance with adjustment for baseline was used; for categorical data, Fisher's exact tests were used. Between group differences in diversity and differential abundance of taxa and potential functions of the microbiome were analysed using linear mixed effects models and FDR correction.
In total, 59 individuals were randomised (29 MD, 30 control) and 48 completed the trial. Seven of 11 withdrawals were due to antibiotic commencement. The MEDAS score was higher at 6 weeks in MD vs controls (7.5 [95% CI: 6.9, 8.0] vs 5.7 [5.2, 6.3], p<0.001) and there was no difference in total FODMAP intake (p=0.51). There was a greater proportion of IBS-SSS responders in MD vs controls (≥50-point reduction; 83% vs 37%, p<0.001), HADS-A responders (≥2-point reduction; 62% vs 23%, p=0.004), HADS-D responders (52% vs 20%, p=0.015) and IBS-QOL responders (≥14-point reduction 62% vs 23%, p=0.004). Gastrointestinal adverse events were similar between groups (p=0.588). There were no differences between groups in change in microbiome alpha diversity (richness, Shannon Index), beta diversity, relative abundance of taxa, or functional potential.
The MD is feasible in IBS and leads to dual improvement in gastrointestinal and psychological symptoms. Future larger blinded trials are required to confirm these findings and to determine if the microbiome is an underlying mechanism.
Adults aged 18-65 years with Rome IV IBS and mild or moderate anxiety and/or depressive symptoms were recruited to a 6-week RCT. Significant medical or mental health conditions (e.g. inflammatory bowel disease, bipolar disorder) and recent change in IBS or psychotropic treatment were excluded. Patients were randomised to MD advice from a dietitian or advice to continue habitual diet. Diet adherence was measured using a Mediterranean diet adherence screener (MEDAS). Gastrointestinal symptoms (IBS-SSS), psychological symptoms (HADS) and quality of life (IBS-QOL) data were collected at baseline and follow up. Stool samples were collected for metagenomic sequencing. Data were analysed on an intention-to-treat basis. For continuous variables, analysis of covariance with adjustment for baseline was used; for categorical data, Fisher's exact tests were used. Between group differences in diversity and differential abundance of taxa and potential functions of the microbiome were analysed using linear mixed effects models and FDR correction.
In total, 59 individuals were randomised (29 MD, 30 control) and 48 completed the trial. Seven of 11 withdrawals were due to antibiotic commencement. The MEDAS score was higher at 6 weeks in MD vs controls (7.5 [95% CI: 6.9, 8.0] vs 5.7 [5.2, 6.3], p<0.001) and there was no difference in total FODMAP intake (p=0.51). There was a greater proportion of IBS-SSS responders in MD vs controls (≥50-point reduction; 83% vs 37%, p<0.001), HADS-A responders (≥2-point reduction; 62% vs 23%, p=0.004), HADS-D responders (52% vs 20%, p=0.015) and IBS-QOL responders (≥14-point reduction 62% vs 23%, p=0.004). Gastrointestinal adverse events were similar between groups (p=0.588). There were no differences between groups in change in microbiome alpha diversity (richness, Shannon Index), beta diversity, relative abundance of taxa, or functional potential.
The MD is feasible in IBS and leads to dual improvement in gastrointestinal and psychological symptoms. Future larger blinded trials are required to confirm these findings and to determine if the microbiome is an underlying mechanism.
Gut-brain dysregulation and microbiome dysfunction are central to the pathogenesis of irritable bowel syndrome (IBS). Depressive and anxiety symptoms are highly prevalent and contribute to disease burden but are not commonly addressed in practice. The low FODMAP diet is efficacious for managing gastrointestinal symptoms but may not be appropriate in those with psychological comorbidity due to its complexity. A Mediterranean diet (MD), rich in vegetables, pulses, wholegrains and olive oil, has potential benefit in IBS as it leads to positive shifts in microbiome composition and function, and RCTs have demonstrated antidepressant effects. The TANDIM trial aimed to assess the feasibility of a MD in patients with IBS and psychological comorbidity.
Adults aged 18-65 years with Rome IV IBS and mild or moderate anxiety and/or depressive symptoms were recruited to a 6-week RCT. Significant medical or mental health conditions (e.g. inflammatory bowel disease, bipolar disorder) and recent change in IBS or psychotropic treatment were excluded. Patients were randomised to MD advice from a dietitian or advice to continue habitual diet. Diet adherence was measured using a Mediterranean diet adherence screener (MEDAS). Gastrointestinal symptoms (IBS-SSS), psychological symptoms (HADS) and quality of life (IBS-QOL) data were collected at baseline and follow up. Stool samples were collected for metagenomic sequencing. Data were analysed on an intention-to-treat basis. For continuous variables, analysis of covariance with adjustment for baseline was used; for categorical data, Fisher's exact tests were used. Between group differences in diversity and differential abundance of taxa and potential functions of the microbiome were analysed using linear mixed effects models and FDR correction.
In total, 59 individuals were randomised (29 MD, 30 control) and 48 completed the trial. Seven of 11 withdrawals were due to antibiotic commencement. The MEDAS score was higher at 6 weeks in MD vs controls (7.5 [95% CI: 6.9, 8.0] vs 5.7 [5.2, 6.3], p<0.001) and there was no difference in total FODMAP intake (p=0.51). There was a greater proportion of IBS-SSS responders in MD vs controls (≥50-point reduction; 83% vs 37%, p<0.001), HADS-A responders (≥2-point reduction; 62% vs 23%, p=0.004), HADS-D responders (52% vs 20%, p=0.015) and IBS-QOL responders (≥14-point reduction 62% vs 23%, p=0.004). Gastrointestinal adverse events were similar between groups (p=0.588). There were no differences between groups in change in microbiome alpha diversity (richness, Shannon Index), beta diversity, relative abundance of taxa, or functional potential.
The MD is feasible in IBS and leads to dual improvement in gastrointestinal and psychological symptoms. Future larger blinded trials are required to confirm these findings and to determine if the microbiome is an underlying mechanism.
Adults aged 18-65 years with Rome IV IBS and mild or moderate anxiety and/or depressive symptoms were recruited to a 6-week RCT. Significant medical or mental health conditions (e.g. inflammatory bowel disease, bipolar disorder) and recent change in IBS or psychotropic treatment were excluded. Patients were randomised to MD advice from a dietitian or advice to continue habitual diet. Diet adherence was measured using a Mediterranean diet adherence screener (MEDAS). Gastrointestinal symptoms (IBS-SSS), psychological symptoms (HADS) and quality of life (IBS-QOL) data were collected at baseline and follow up. Stool samples were collected for metagenomic sequencing. Data were analysed on an intention-to-treat basis. For continuous variables, analysis of covariance with adjustment for baseline was used; for categorical data, Fisher's exact tests were used. Between group differences in diversity and differential abundance of taxa and potential functions of the microbiome were analysed using linear mixed effects models and FDR correction.
In total, 59 individuals were randomised (29 MD, 30 control) and 48 completed the trial. Seven of 11 withdrawals were due to antibiotic commencement. The MEDAS score was higher at 6 weeks in MD vs controls (7.5 [95% CI: 6.9, 8.0] vs 5.7 [5.2, 6.3], p<0.001) and there was no difference in total FODMAP intake (p=0.51). There was a greater proportion of IBS-SSS responders in MD vs controls (≥50-point reduction; 83% vs 37%, p<0.001), HADS-A responders (≥2-point reduction; 62% vs 23%, p=0.004), HADS-D responders (52% vs 20%, p=0.015) and IBS-QOL responders (≥14-point reduction 62% vs 23%, p=0.004). Gastrointestinal adverse events were similar between groups (p=0.588). There were no differences between groups in change in microbiome alpha diversity (richness, Shannon Index), beta diversity, relative abundance of taxa, or functional potential.
The MD is feasible in IBS and leads to dual improvement in gastrointestinal and psychological symptoms. Future larger blinded trials are required to confirm these findings and to determine if the microbiome is an underlying mechanism.
A MEDITERRANEAN DIET IS FEASIBLE IN PATIENTS WITH IRRITABLE BOWEL SYNDROME: A PILOT RANDOMISED CONTROLLED TRIAL.
Heidi Staudacher
Abstract
Gut-brain dysregulation and microbiome dysfunction are central to the pathogenesis of irritable bowel syndrome (IBS). Depressive and anxiety symptoms are highly prevalent and contribute to disease burden but are not commonly addressed in practice. The low FODMAP diet is efficacious for managing gastrointestinal symptoms but may not be appropriate in those with psychological comorbidity due to its complexity. A Mediterranean diet (MD), rich in vegetables, pulses, wholegrains and olive oil, has potential benefit in IBS as it leads to positive shifts in microbiome composition and function, and RCTs have demonstrated antidepressant effects. The TANDIM trial aimed to assess the feasibility of a MD in patients with IBS and psychological comorbidity.
Adults aged 18-65 years with Rome IV IBS and mild or moderate anxiety and/or depressive symptoms were recruited to a 6-week RCT. Significant medical or mental health conditions (e.g. inflammatory bowel disease, bipolar disorder) and recent change in IBS or psychotropic treatment were excluded. Patients were randomised to MD advice from a dietitian or advice to continue habitual diet. Diet adherence was measured using a Mediterranean diet adherence screener (MEDAS). Gastrointestinal symptoms (IBS-SSS), psychological symptoms (HADS) and quality of life (IBS-QOL) data were collected at baseline and follow up. Stool samples were collected for metagenomic sequencing. Data were analysed on an intention-to-treat basis. For continuous variables, analysis of covariance with adjustment for baseline was used; for categorical data, Fisher's exact tests were used. Between group differences in diversity and differential abundance of taxa and potential functions of the microbiome were analysed using linear mixed effects models and FDR correction.
In total, 59 individuals were randomised (29 MD, 30 control) and 48 completed the trial. Seven of 11 withdrawals were due to antibiotic commencement. The MEDAS score was higher at 6 weeks in MD vs controls (7.5 [95% CI: 6.9, 8.0] vs 5.7 [5.2, 6.3], p<0.001) and there was no difference in total FODMAP intake (p=0.51). There was a greater proportion of IBS-SSS responders in MD vs controls (≥50-point reduction; 83% vs 37%, p<0.001), HADS-A responders (≥2-point reduction; 62% vs 23%, p=0.004), HADS-D responders (52% vs 20%, p=0.015) and IBS-QOL responders (≥14-point reduction 62% vs 23%, p=0.004). Gastrointestinal adverse events were similar between groups (p=0.588). There were no differences between groups in change in microbiome alpha diversity (richness, Shannon Index), beta diversity, relative abundance of taxa, or functional potential.
The MD is feasible in IBS and leads to dual improvement in gastrointestinal and psychological symptoms. Future larger blinded trials are required to confirm these findings and to determine if the microbiome is an underlying mechanism.
Adults aged 18-65 years with Rome IV IBS and mild or moderate anxiety and/or depressive symptoms were recruited to a 6-week RCT. Significant medical or mental health conditions (e.g. inflammatory bowel disease, bipolar disorder) and recent change in IBS or psychotropic treatment were excluded. Patients were randomised to MD advice from a dietitian or advice to continue habitual diet. Diet adherence was measured using a Mediterranean diet adherence screener (MEDAS). Gastrointestinal symptoms (IBS-SSS), psychological symptoms (HADS) and quality of life (IBS-QOL) data were collected at baseline and follow up. Stool samples were collected for metagenomic sequencing. Data were analysed on an intention-to-treat basis. For continuous variables, analysis of covariance with adjustment for baseline was used; for categorical data, Fisher's exact tests were used. Between group differences in diversity and differential abundance of taxa and potential functions of the microbiome were analysed using linear mixed effects models and FDR correction.
In total, 59 individuals were randomised (29 MD, 30 control) and 48 completed the trial. Seven of 11 withdrawals were due to antibiotic commencement. The MEDAS score was higher at 6 weeks in MD vs controls (7.5 [95% CI: 6.9, 8.0] vs 5.7 [5.2, 6.3], p<0.001) and there was no difference in total FODMAP intake (p=0.51). There was a greater proportion of IBS-SSS responders in MD vs controls (≥50-point reduction; 83% vs 37%, p<0.001), HADS-A responders (≥2-point reduction; 62% vs 23%, p=0.004), HADS-D responders (52% vs 20%, p=0.015) and IBS-QOL responders (≥14-point reduction 62% vs 23%, p=0.004). Gastrointestinal adverse events were similar between groups (p=0.588). There were no differences between groups in change in microbiome alpha diversity (richness, Shannon Index), beta diversity, relative abundance of taxa, or functional potential.
The MD is feasible in IBS and leads to dual improvement in gastrointestinal and psychological symptoms. Future larger blinded trials are required to confirm these findings and to determine if the microbiome is an underlying mechanism.
Gut-brain dysregulation and microbiome dysfunction are central to the pathogenesis of irritable bowel syndrome (IBS). Depressive and anxiety symptoms are highly prevalent and contribute to disease burden but are not commonly addressed in practice. The low FODMAP diet is efficacious for managing gastrointestinal symptoms but may not be appropriate in those with psychological comorbidity due to its complexity. A Mediterranean diet (MD), rich in vegetables, pulses, wholegrains and olive oil, has potential benefit in IBS as it leads to positive shifts in microbiome composition and function, and RCTs have demonstrated antidepressant effects. The TANDIM trial aimed to assess the feasibility of a MD in patients with IBS and psychological comorbidity.
Adults aged 18-65 years with Rome IV IBS and mild or moderate anxiety and/or depressive symptoms were recruited to a 6-week RCT. Significant medical or mental health conditions (e.g. inflammatory bowel disease, bipolar disorder) and recent change in IBS or psychotropic treatment were excluded. Patients were randomised to MD advice from a dietitian or advice to continue habitual diet. Diet adherence was measured using a Mediterranean diet adherence screener (MEDAS). Gastrointestinal symptoms (IBS-SSS), psychological symptoms (HADS) and quality of life (IBS-QOL) data were collected at baseline and follow up. Stool samples were collected for metagenomic sequencing. Data were analysed on an intention-to-treat basis. For continuous variables, analysis of covariance with adjustment for baseline was used; for categorical data, Fisher's exact tests were used. Between group differences in diversity and differential abundance of taxa and potential functions of the microbiome were analysed using linear mixed effects models and FDR correction.
In total, 59 individuals were randomised (29 MD, 30 control) and 48 completed the trial. Seven of 11 withdrawals were due to antibiotic commencement. The MEDAS score was higher at 6 weeks in MD vs controls (7.5 [95% CI: 6.9, 8.0] vs 5.7 [5.2, 6.3], p<0.001) and there was no difference in total FODMAP intake (p=0.51). There was a greater proportion of IBS-SSS responders in MD vs controls (≥50-point reduction; 83% vs 37%, p<0.001), HADS-A responders (≥2-point reduction; 62% vs 23%, p=0.004), HADS-D responders (52% vs 20%, p=0.015) and IBS-QOL responders (≥14-point reduction 62% vs 23%, p=0.004). Gastrointestinal adverse events were similar between groups (p=0.588). There were no differences between groups in change in microbiome alpha diversity (richness, Shannon Index), beta diversity, relative abundance of taxa, or functional potential.
The MD is feasible in IBS and leads to dual improvement in gastrointestinal and psychological symptoms. Future larger blinded trials are required to confirm these findings and to determine if the microbiome is an underlying mechanism.
Adults aged 18-65 years with Rome IV IBS and mild or moderate anxiety and/or depressive symptoms were recruited to a 6-week RCT. Significant medical or mental health conditions (e.g. inflammatory bowel disease, bipolar disorder) and recent change in IBS or psychotropic treatment were excluded. Patients were randomised to MD advice from a dietitian or advice to continue habitual diet. Diet adherence was measured using a Mediterranean diet adherence screener (MEDAS). Gastrointestinal symptoms (IBS-SSS), psychological symptoms (HADS) and quality of life (IBS-QOL) data were collected at baseline and follow up. Stool samples were collected for metagenomic sequencing. Data were analysed on an intention-to-treat basis. For continuous variables, analysis of covariance with adjustment for baseline was used; for categorical data, Fisher's exact tests were used. Between group differences in diversity and differential abundance of taxa and potential functions of the microbiome were analysed using linear mixed effects models and FDR correction.
In total, 59 individuals were randomised (29 MD, 30 control) and 48 completed the trial. Seven of 11 withdrawals were due to antibiotic commencement. The MEDAS score was higher at 6 weeks in MD vs controls (7.5 [95% CI: 6.9, 8.0] vs 5.7 [5.2, 6.3], p<0.001) and there was no difference in total FODMAP intake (p=0.51). There was a greater proportion of IBS-SSS responders in MD vs controls (≥50-point reduction; 83% vs 37%, p<0.001), HADS-A responders (≥2-point reduction; 62% vs 23%, p=0.004), HADS-D responders (52% vs 20%, p=0.015) and IBS-QOL responders (≥14-point reduction 62% vs 23%, p=0.004). Gastrointestinal adverse events were similar between groups (p=0.588). There were no differences between groups in change in microbiome alpha diversity (richness, Shannon Index), beta diversity, relative abundance of taxa, or functional potential.
The MD is feasible in IBS and leads to dual improvement in gastrointestinal and psychological symptoms. Future larger blinded trials are required to confirm these findings and to determine if the microbiome is an underlying mechanism.
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