RECRUITING

Novel Pilot Study to Treat Symptoms of IBS with Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator

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Conditions

IBS - Irritable Bowel SyndromeDiarrheaIBSIrritable Bowel Syndrome

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. These are short-chain carbohydrates that can cause digestive distress in some people. You have been asked to take part in this research because you have symptoms of diarrhea-predominant irritable bowel syndrome that may respond to treatment with a combination of a medication called mirtazapine and a low-FODMAP diet.

Official Title

Novel Pilot Study to Treat Symptoms of IBS with Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator

Quick Facts

Study Start:2024-12-19
Study Completion:2025-12-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06684470

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must meet all of the inclusion criteria to participate in this study:
  2. * Adults (ages 18-70)
  3. * Score of \>175 on the IBS-SSS questionnaire
  4. * Must meet Rome IV criteria for IBS-D
  5. * If subject is of reproductive capability a negative urine pregnancy test must be available prior to entering the study
  6. * Ability to understand study procedures and to comply with them for the entire length of the study
  1. * All candidates meeting any of the below exclusion criteria at baseline will be excluded from study participation:
  2. * Score of \< 175 on the IBS-SSS
  3. * Prior diagnoses of: known celiac disease, small intestinal bacterial overgrowth, inflammatory bowel disease, or microscopic colitis
  4. * Ongoing significant anxiety or depression
  5. * A history of a known side effect to mirtazapine
  6. * Prior treatment with a low FODMAP diet or mirtazapine without clinical benefit
  7. * Active alcohol or drug abuse
  8. * Inability to read or understand the consent form
  9. * Any other medical or psychological reason that would prevent active participation in a research study
  10. * Pregnant females

Contacts and Locations

Study Contact

Jessica C Petrov, MD
CONTACT
904-953-2000
Petrov.Jessica@mayo.edu

Principal Investigator

Brian E Lacy, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic
Jacksonville, Florida, 32224
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Brian E Lacy, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-19
Study Completion Date2025-12-19

Study Record Updates

Study Start Date2024-12-19
Study Completion Date2025-12-19

Terms related to this study

Keywords Provided by Researchers

  • Diarrhea
  • IBS
  • Irritable Bowel Syndrome

Additional Relevant MeSH Terms

  • IBS - Irritable Bowel Syndrome
  • Diarrhea