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New treatment option for Irritable Bowel Syndrome
Official title Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)
ClinicalTrials.gov ID: NCT06413004
What this study is testing
- What it's testing
- The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients, with and without Brachyspira infection, using advanced imaging. We hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Patients with IBS diagnosis according to their treating physician (ROME IV).
- Association between intake of food and GI symptoms.
- Witnessed written informed consent prior to any study procedures.
- Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements.
You likely can't join if
- Patients with relevant concurrent organic GI disease (inflammatory bowel disease, abdominal cancer), or a major disease such as diabetes...
- Patients with a history of bowel surgery (not appendectomy or cholecystectomy) that affects GI motility.
- Patients with systemic food allergy as evidenced by positive allergy tests (blood, prick test).
- Clinical history of severe allergic reactions.
- Patients with concurrent major confounding condition(s) based on the clinician's judgement, e.g. DOMINANT psychiatric disorder, vital depression...
- Female patients who are pregnant or lactating (females of fertile age are requested to use a safe contraceptive) at the time of inclusion.
See the full eligibility criteria
- Patients with IBS diagnosis according to their treating physician (ROME IV).
- Association between intake of food and GI symptoms.
- Witnessed written informed consent prior to any study procedures.
- Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements.
- Patients with relevant concurrent organic GI disease (inflammatory bowel disease, abdominal cancer), or a major disease such as diabetes, uncontrolled thyroid disease, heart disease, kidney disease, liver disease, and...
- Patients with a history of bowel surgery (not appendectomy or cholecystectomy) that affects GI motility.
- Patients with systemic food allergy as evidenced by positive allergy tests (blood, prick test).
- Clinical history of severe allergic reactions.
- Patients with concurrent major confounding condition(s) based on the clinician's judgement, e.g. DOMINANT psychiatric disorder, vital depression, alcohol or substance abuse in the last 2 year.
- Female patients who are pregnant or lactating (females of fertile age are requested to use a safe contraceptive) at the time of inclusion.
- Patients who use or used new medications that affect the GI functioning within 1 month before the start of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Gothenburg, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gothenburg, Sweden. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.