Actively Recruiting
Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)
Led by Magnus Simrén · Updated on 2024-05-14
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating local immune responses in the gastrointestinal (GI) tract to food antigens in patients with Irritable Bowel Syndrome (IBS), both with and without Brachyspira infection. They believe that Brachyspira infection may trigger IBS symptoms by causing the immune system to react abnormally to certain foods, leading to increased sensitivity in the gut. This study uses advanced imaging techniques to better understand these food-specific immune reactions and their role in IBS symptoms. Participants undergo several procedures including either confocal laser endomicroscopy (CLE) or a colonoscopic allergen provocation test (COLAP) to identify food reactions in the gut. Other tests include rectal barostat examinations to measure sensitivity, sigmoidoscopy without laxatives for biopsies, and multiple biological sample collections. If a food reaction is detected, participants follow a diet excluding the identified food for four weeks, followed by reintroduction and monitoring. Throughout the study, participants complete questionnaires about their symptoms, psychological health, and diet. Researchers collect blood, stool, urine, and biopsy samples to analyze immune and metabolic markers. The main outcome measured is the IBS symptom severity score after excluding and reintroducing the food. The study includes several visits over weeks with detailed assessments to better understand the link between food reactions and IBS symptoms.
CONDITIONS
Brief Title
Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with IBS according to their treating physician using ROME IV criteria
- Experience a link between food intake and gastrointestinal symptoms
- Provide witnessed written informed consent before any study procedures
- Able to understand the study, complete questionnaires, and follow study requirements
You will not qualify if you...
- Presence of significant organic gastrointestinal diseases like inflammatory bowel disease or abdominal cancer
- Major diseases such as diabetes, uncontrolled thyroid, heart, kidney, liver disease, or active cancer not in remission for at least 5 years
- History of bowel surgery affecting gastrointestinal motility except appendectomy or cholecystectomy
- Confirmed systemic food allergy through blood or skin tests
- History of severe allergic reactions
- Major psychiatric disorders, vital depression, or substance abuse within the last 2 years
- Pregnant or breastfeeding women; women of childbearing potential must use safe contraception
- Use of new medications affecting gastrointestinal function within 1 month before study start
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 visits over several weeks
Participants undergo questionnaires, blood and stool sample collection, rectal barostat examination, sigmoidoscopy, allergologist assessment, and confocal laser endomicroscopy (CLE) or colonoscopic allergen provocation test (COLAP) to detect food antigen immune responses.
3 visits (in-person)
Duration - 8 weeks (4 weeks elimination and 4 weeks re-introduction)
Participants with positive CLE or COLAP results eliminate the identified food item(s) for 4 weeks, followed by re-introduction of the food item(s) for another 4 weeks with dietician guidance and repeated assessments.
3 visits (in-person)
Trial Site Locations
Total: 1 location
1
Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital
Gothenburg, Sweden, 413 45
Actively Recruiting
Research Team
M
Magnus Simrén, MD PhD
M
MagTarmlab office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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