Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06548399
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
Longitudinal Study on Bacterial Production of LPC and LPA in Patients With Inflammatory Bowel Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bacterial Production of LPC and LPA and Symptoms Generation in Inflammatory Bowel Disease Patients With Chronic Abdominal Pain a Longitudinal Exploratory Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Long-IBD
Brief Summary:
The purpose of this study is to investigate whether the gut bacteria in IBD patients cause ongoing abdominal pain even when the disease is calm Many inflammatory bowel disease IBD patients have this pain regardless of whether their disease is active or not This might be linked to an imbalance in gut bacteria Certain IBD patients with persistent abdominal pain experience increased sensitivity in their gut due to bacteria producing LPC and LPA Our goal is to explore the connection between bacterial LPCLPA levels and symptoms in IBD patients with long-lasting abdominal pain Additionally we aim to pinpoint the specific bacteria responsible for producing LPCLPA which in turn causes chronic abdominal pain in these patients
Detailed Description:
The human body is inhabited by a complex community of microbes collectively referred to as microbiota A vast majority of these bacteria are found in the lumen of the gastrontestinal tract colon small intestine stomach and esophagus Several lines of evidence indicate that changes in microbiota bacteria may be involved in the origin of different gastrointestinal diseases including inflammatory Bowel Disease IBD with its two main types Crohns disease and Ulcerative colitis
Our recent data suggest that the gut bacteria have the capability to produce lysophosphatidylcholine LPC and its derivative lysophosphatidic acid LPA small lipid molecules that are were shown previously to be involved in the genesis and maintenance of chronic pain We found that these molecules are higher in stool of patients with Inflammatory Bowel Disease IBD but it is unclear whether 1 they are produced by gut bacteria and 2 whether their production underlies chronic pain in patients with IBD
The purpose of our study is to determine whether the gut bacteria produce LPC and LPA and induce chronic abdominal pain which is common in many patients with IBD even when their colitis is in remission absence of overt gut inflammation
In this exploratory longitudinal study we will recruit patients with IBD aged 18-70 years of both sexes with a history of moderate to severe chronic abdominal pain as defined by their gastroenterologist which persists during remission of colitis absence of overt inflammation on CT or MRI imaging and baseline fecal calprotectin lt200 μgg of stool or while having only mild gut inflammation defined by either colonoscopy Endoscopic Mayo score 0-1 or Simple Endoscopic Score for Crohns Disease score 0-10 We will recruit 15 patients with baseline stool LPC gt200 μgmg and LPA gt100 μgmg levels after first assessment in screening visit Recruitment will take place at McMaster University IBD clinic currently caring for over 1600 patients with IBD httpswwwmcmasteribdcom
After study participant meets the eligibility criteria and signs the informed consent we will collect stool and urine samples and abdominal pain scores for 3 weeks Monday to Friday each week Daily stool and urine samples first stool of the day and morning overnight urine will be collected and LPCLPA measured by ELISA Abdominal pain will be assessed daily with a visual analogue scale VAS In addition clinical symptoms will be evaluated by PROMIS GI Belly Pain Diarrhea Constipation and Bloating and DASS-21 questionnaires at the end of each week as they assess symptoms during the preceding 7 days Dietary intake will be assessed at the beginning of each week by a 3-day food diary The clinical surveys will be provided online using RedCap software and secure servers already operational within McMaster
Our recent data suggest that the gut bacteria have the capability to produce lysophosphatidylcholine LPC and its derivative lysophosphatidic acid LPA small lipid molecules that are were shown previously to be involved in the genesis and maintenance of chronic pain We found that these molecules are higher in stool of patients with Inflammatory Bowel Disease IBD but it is unclear whether 1 they are produced by gut bacteria and 2 whether their production underlies chronic pain in patients with IBD
The purpose of our study is to determine whether the gut bacteria produce LPC and LPA and induce chronic abdominal pain which is common in many patients with IBD even when their colitis is in remission absence of overt gut inflammation
In this exploratory longitudinal study we will recruit patients with IBD aged 18-70 years of both sexes with a history of moderate to severe chronic abdominal pain as defined by their gastroenterologist which persists during remission of colitis absence of overt inflammation on CT or MRI imaging and baseline fecal calprotectin lt200 μgg of stool or while having only mild gut inflammation defined by either colonoscopy Endoscopic Mayo score 0-1 or Simple Endoscopic Score for Crohns Disease score 0-10 We will recruit 15 patients with baseline stool LPC gt200 μgmg and LPA gt100 μgmg levels after first assessment in screening visit Recruitment will take place at McMaster University IBD clinic currently caring for over 1600 patients with IBD httpswwwmcmasteribdcom
After study participant meets the eligibility criteria and signs the informed consent we will collect stool and urine samples and abdominal pain scores for 3 weeks Monday to Friday each week Daily stool and urine samples first stool of the day and morning overnight urine will be collected and LPCLPA measured by ELISA Abdominal pain will be assessed daily with a visual analogue scale VAS In addition clinical symptoms will be evaluated by PROMIS GI Belly Pain Diarrhea Constipation and Bloating and DASS-21 questionnaires at the end of each week as they assess symptoms during the preceding 7 days Dietary intake will be assessed at the beginning of each week by a 3-day food diary The clinical surveys will be provided online using RedCap software and secure servers already operational within McMaster
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