Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04315714
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2020-03-17
Brief Title:
Impact of a Yoga Intervention on Pain and Multiomics in Participants With IBS
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Impact of a Yoga Intervention on Chronic Abdominal Pain and Associations With the Metagenome and Metabolome in Participants With IBS
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to see if a six-week yoga program delivered onlinevirtually via Zoom reduces abdominal pain in people with irritable bowel syndrome IBS This study also looks at whether the yoga program changes the composition of microorganisms in the gut and their metabolites and compares the program in people with IBS versus healthy people also known as healthy controls or HC People in this study are randomized like flipping a coin to one of two conditions half of the people attend the onlinevirtual private yoga program delivered via Zoom for the first six-weeks and half of the people wait for six-weeks and then attend the onlinevirtual private yoga program for six-weeks The hypothesis of this study is that the practice of yoga induces shifts in the gut microbiota and microbial-derived metabolites which will correlate with diminished abdominal pain
Detailed Description:
Chronic abdominal pain is a hallmark feature of irritable bowel syndrome IBS1 a prevalent2 costly disorder3 that disproportionately affects the female sex4 IBS is often comorbid with psychiatric disorders and other pain-related conditions and although pathophysiology is not yet fully understood alterations in the gut microbiota epithelial barrier and immune response are among factors noted to play a role5 Bidirectional signaling between the brain the gut and its microbiome is relevant to the disorder of IBS with top-down signaling including through the autonomic nervous system and bottom-up signaling through microbial-derived intermediates including secondary bile acids short-chain fatty acids SCFA and tryptophan metabolites6 Diet and lifestyle are critical determinants of the microbiota composition7 thus interventions which modulate the microbiota and affect microbial-derived intermediates have the potential to improve patient symptomatology A recent meta-analysis of common dietary interventions for IBS however demonstrates insufficient evidence to recommend a gluten-free diet and very low quality evidence supporting the efficacy a low fermentable oligo-di-and monosaccharides and polyols FODMAP diet to reduce symptoms of IBS8 Therefore a need exists to identify alternative lifestyle interventions for patients with IBS and given the acknowledged role of the microbiota in pathophysiology enhance our understanding of how such interventions modulate the microbiota affect microbial-derived intermediates and influence patient symptoms of chronic abdominal pain
A lifestyle intervention of increasing interest in IBS research is physical activity a recent systematic review suggests exercise to improve gastrointestinal GI symptoms anxiety depression stress and quality of life9 The practice of yoga in particular benefits anxiety quality of life and GI symptoms in patients with IBS10 although physiological underpinnings of this effect remain understudied in IBS A recent meta-analysis of randomized controlled trials comparing the practice of yoga asanas body postures with active controls across patient populations reports yoga to improve cortisol cytokines autonomic measures fasting blood glucose and lipids11 An additional pathway by which yoga may affect symptomatology in IBS is along the gut microbiota-skeletal muscle axis Preclinical findings report the gut microbiota to influence skeletal muscle mass and function in mice with germ free mice displaying altered amino acid metabolism12 Importantly this gut-muscle axis appears bi-directional in that microbiota may modulate muscle function through nutrient synthesis and biotransformation whereas regular exercise can modulate the composition of the microbiota and enhance gut microbiota diversity13 Exercise training has been found to increase concentrations of SCFA including butyrate14 a microbial end product with beneficial effects upon intestinal inflammation immunity and gut barrier function15 and levels of which have been noted as altered in patients with IBS in comparison with healthy controls HC16 The gut microbiota of patients with IBS compared with HC consistently includes lower microbial α-diversity decreased levels of Bacteroidetes increased levels of Firmicutes and increased FB ratio17 Metagenomics and metabolomics used in combination can provide a comprehensive overview of microbiome-host interactions18 This was demonstrated by a recent investigation of children with IBS and HC in which IBS children were found to be enriched in bacterial taxa eg Flavonifractor plautii metagenomics functional profile eg amino acid metabolism higher-order metabolites eg secondary bile acids and associations were noted with abdominal pain19
The investigators of this study hypothesize that participants with IBS differ from HC in lower microbial α-diversity and reduced SCFA specifically butyrate which will be associated with abdominal pain Furthermore the investigators of this study hypothesize that the practice of yoga induces shifts in the gut microbiota and microbial-derived metabolites specifically butyrate which will correlate with diminished abdominal pain To test these hypotheses the investigators of this study propose the following two aims
Specific Aim 1 Identify differences in microbial features and metabolites among participants with IBS and HC at baseline and evaluate associations with participant characteristics
Specific Aim 2 Determine if a 6-week yoga intervention delivered onlinevirtually via Zoom reduces abdominal pain among participants with IBS and evaluate associations with microbial features and metabolites
Findings from this study will enhance our understanding of the interplay between the microbiota microbial-derived intermediates and pain in patients with IBS Furthermore this research will facilitate the identification of relevant microbial features and metabolites that may prove modifiable and work towards diminishing the public health burden surrounding chronic pain
A lifestyle intervention of increasing interest in IBS research is physical activity a recent systematic review suggests exercise to improve gastrointestinal GI symptoms anxiety depression stress and quality of life9 The practice of yoga in particular benefits anxiety quality of life and GI symptoms in patients with IBS10 although physiological underpinnings of this effect remain understudied in IBS A recent meta-analysis of randomized controlled trials comparing the practice of yoga asanas body postures with active controls across patient populations reports yoga to improve cortisol cytokines autonomic measures fasting blood glucose and lipids11 An additional pathway by which yoga may affect symptomatology in IBS is along the gut microbiota-skeletal muscle axis Preclinical findings report the gut microbiota to influence skeletal muscle mass and function in mice with germ free mice displaying altered amino acid metabolism12 Importantly this gut-muscle axis appears bi-directional in that microbiota may modulate muscle function through nutrient synthesis and biotransformation whereas regular exercise can modulate the composition of the microbiota and enhance gut microbiota diversity13 Exercise training has been found to increase concentrations of SCFA including butyrate14 a microbial end product with beneficial effects upon intestinal inflammation immunity and gut barrier function15 and levels of which have been noted as altered in patients with IBS in comparison with healthy controls HC16 The gut microbiota of patients with IBS compared with HC consistently includes lower microbial α-diversity decreased levels of Bacteroidetes increased levels of Firmicutes and increased FB ratio17 Metagenomics and metabolomics used in combination can provide a comprehensive overview of microbiome-host interactions18 This was demonstrated by a recent investigation of children with IBS and HC in which IBS children were found to be enriched in bacterial taxa eg Flavonifractor plautii metagenomics functional profile eg amino acid metabolism higher-order metabolites eg secondary bile acids and associations were noted with abdominal pain19
The investigators of this study hypothesize that participants with IBS differ from HC in lower microbial α-diversity and reduced SCFA specifically butyrate which will be associated with abdominal pain Furthermore the investigators of this study hypothesize that the practice of yoga induces shifts in the gut microbiota and microbial-derived metabolites specifically butyrate which will correlate with diminished abdominal pain To test these hypotheses the investigators of this study propose the following two aims
Specific Aim 1 Identify differences in microbial features and metabolites among participants with IBS and HC at baseline and evaluate associations with participant characteristics
Specific Aim 2 Determine if a 6-week yoga intervention delivered onlinevirtually via Zoom reduces abdominal pain among participants with IBS and evaluate associations with microbial features and metabolites
Findings from this study will enhance our understanding of the interplay between the microbiota microbial-derived intermediates and pain in patients with IBS Furthermore this research will facilitate the identification of relevant microbial features and metabolites that may prove modifiable and work towards diminishing the public health burden surrounding chronic pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P30NR016579-01 | NIH | None | httpsreporternihgovquickSearch1P30NR016579-01 |