Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610929
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Intestinal Microbiota and Visceral Pain in Chronic Intestinal Pseudo-Obstruction Syndrome CIPO
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Metabolites From the Intestinal Microbiota and Visceral Pain Associated With Chronic Intestinal Pseudo-obstruction CIPO in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
METADOLOMIC
Brief Summary:
Chronic Intestinal Pseudo-Obstruction Syndrome CIPO is a rare gastrointestinal motility disorder CIPO evolves through iterative flare-ups that can be triggered by viral or bacterial infections psychological stress or malnutrition All of these factors are associated with dysbiosis of the intestinal microbiota IM Many studies have associated visceral pain with dysbiosis of the IM particularly in the context of irritable bowel syndrome IBS a painful pathology associated with transit disorders The team in Dr Cénacs laboratory has demonstrated the analgesic effect of a bacterial lipid produced by an intestinal bacterium in the context of IBS The study hypothesize that CIPO patients have a taxonomic and functional dysbiosis of the IM responsible for hyperactivation of sensory neurons inducing visceral pain
Detailed Description:
The aim of the study is to identify metabolites differentially produced by the gut microbiota of CIPO patients with visceral pain to determine their effect on the host with a focus on intestinal homeostasis
For that 3 samples of digestive effluent will be collected in paediatric CIPO patients
Then the study will
1 Characterize the intestinal microbiota of digestive effluents from painful and non-painful pediatric CIPO patients
2 Quantify bacterial lipids in digestive effluents from painful and non-painful paediatric CIPO patients In ileal effluents we will perform absolute quantification of the bacterial lipidome We will quantify short-chain fatty acids by gas chromatography coupled with mass spectrometry and long-chain beta-hydroxylated fatty acids GABA-lipopeptides lipoamines and primary and secondary bile acids by liquid chromatography coupled with tandem mass spectrometry
3 Test the function of these bacterial lipids on sensory neuronal activity in a primary culture of mouse dorsal root ganglia The effects of bacterial lipids on sensory neurons will be evaluated in a primary culture of mouse dorsal root ganglia We will quantify calcium mobilization in sensory neurons treated with the lipid compounds identified above In a second step in order to determine their inhibitory potential the same experiments will be performed on neurons activated by a calcium channel receptor agonist TRPV1 capsaicin or by a mix of agonists histamine serotonin and bradykinin of G protein-coupled receptors involved in visceral hypersensitivity
For that 3 samples of digestive effluent will be collected in paediatric CIPO patients
Then the study will
1 Characterize the intestinal microbiota of digestive effluents from painful and non-painful pediatric CIPO patients
2 Quantify bacterial lipids in digestive effluents from painful and non-painful paediatric CIPO patients In ileal effluents we will perform absolute quantification of the bacterial lipidome We will quantify short-chain fatty acids by gas chromatography coupled with mass spectrometry and long-chain beta-hydroxylated fatty acids GABA-lipopeptides lipoamines and primary and secondary bile acids by liquid chromatography coupled with tandem mass spectrometry
3 Test the function of these bacterial lipids on sensory neuronal activity in a primary culture of mouse dorsal root ganglia The effects of bacterial lipids on sensory neurons will be evaluated in a primary culture of mouse dorsal root ganglia We will quantify calcium mobilization in sensory neurons treated with the lipid compounds identified above In a second step in order to determine their inhibitory potential the same experiments will be performed on neurons activated by a calcium channel receptor agonist TRPV1 capsaicin or by a mix of agonists histamine serotonin and bradykinin of G protein-coupled receptors involved in visceral hypersensitivity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None