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New treatment option for IBS - Irritable Bowel Syndrome
Official title Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator
ClinicalTrials.gov ID: NCT06684470
What this study is testing
What is Mirtazapine?
Mirtazapine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ibs - irritable bowel syndrome.
Also referred to as Remeron.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this research is to study the added benefit of treating IBS symptoms with a medication called mirtazapine in treating IBS symptoms when paired with a low-FODMAP diet compared to a low-FODMAP diet alone. FODMAP stands for fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Participants must meet all of the to participate in this study:
- Adults (ages 18-70)
- Score of \>175 on the IBS-SSS questionnaire
- Must meet Rome IV criteria for IBS-D
- If subject is of reproductive capability a negative urine pregnancy test must be available prior to entering the study
You likely can't join if
- All candidates meeting any of the below exclusion criteria at baseline will be excluded from study participation:
- Score of \< 175 on the IBS-SSS
- Prior diagnoses of: known celiac disease, small intestinal bacterial overgrowth, inflammatory bowel disease, or microscopic colitis
- Ongoing significant anxiety or depression
- A history of a known side effect to mirtazapine
- Prior treatment with a low FODMAP diet or mirtazapine without clinical benefit
See the full eligibility criteria
- Participants must meet all of the to participate in this study:
- Adults (ages 18-70)
- Score of \>175 on the IBS-SSS questionnaire
- Must meet Rome IV criteria for IBS-D
- If subject is of reproductive capability a negative urine pregnancy test must be available prior to entering the study
- Ability to understand study procedures and to comply with them for the entire length of the study
- All candidates meeting any of the below exclusion criteria at baseline will be excluded from study participation:
- Score of \< 175 on the IBS-SSS
- Prior diagnoses of: known celiac disease, small intestinal bacterial overgrowth, inflammatory bowel disease, or microscopic colitis
- Ongoing significant anxiety or depression
- A history of a known side effect to mirtazapine
- Prior treatment with a low FODMAP diet or mirtazapine without clinical benefit
- Active alcohol or drug abuse
- Inability to read or understand the consent form
- Any other medical or psychological reason that would prevent active participation in a research study
- Pregnant females
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
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 Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.