Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04627727
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-12
First Post:
2020-10-30
Brief Title:
Effect of a Low FODMAP Diet on SIBO
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Effect of a Low FODMAP Diet on SIBO
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-12
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:
Bloating is the most common symptom associated with disorders of brain-gut interaction ie functional bowel disorders such as irritable bowel syndrome a disorder characterized by abdominal pain and altered bowel habits which affects up to 11 of world population A common cause of bloating is small intestinal bacterial overgrowth SIBO a condition defined by excessive andor abnormal type of bacteria in the small bowel The potential role of SIBO for irritable bowel syndrome IBS was initially proposed by Pimentel et al Using lactulose breath tests LBTs 78 of patients with IBS were also diagnosed with SIBO After antibiotic therapy 48 of patients no longer met the Rome criteria for IBS A recent systematic review and meta-analysis concluded that the prevalence of SIBO is increased in IBS
Despite the clinical efficacy of LFD in improving symptoms of IBS-D its mechanism of action is not clear Recently Zhou et al have shown FODMAPs induce colonic tight junction dysfunction and visceral hypersensitivity in rat models both of which are reversible when rats were fed an LFD They further showed that this effect of FODMAPs is mediated by microbial dysbiosis and elevated fecal lipopolysaccharide level However studies evaluating the effect of LFD on colonic permeability of humans are lacking Studies have shown significant differences in intra-individual luminal and mucosal microbiome of patients with functional gastrointestinal disorders as well as an increase in Prevotella abundance in IBS patients with SIBO as compared with IBS patients without SIBO Thus the exact effect of FODMAP on intestinal permeability and mucosal microbiome in humans is not clear and needs further evaluation
Despite the clinical efficacy of LFD in improving symptoms of IBS-D its mechanism of action is not clear Recently Zhou et al have shown FODMAPs induce colonic tight junction dysfunction and visceral hypersensitivity in rat models both of which are reversible when rats were fed an LFD They further showed that this effect of FODMAPs is mediated by microbial dysbiosis and elevated fecal lipopolysaccharide level However studies evaluating the effect of LFD on colonic permeability of humans are lacking Studies have shown significant differences in intra-individual luminal and mucosal microbiome of patients with functional gastrointestinal disorders as well as an increase in Prevotella abundance in IBS patients with SIBO as compared with IBS patients without SIBO Thus the exact effect of FODMAP on intestinal permeability and mucosal microbiome in humans is not clear and needs further evaluation
Detailed Description:
None
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