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Search / Trial NCT04526808

Effects of Low FODMAP Diet on Leaky Gut

Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Aug 24, 2020

Trial Information

Current as of April 26, 2025

Active, not recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a low FODMAP diet on people with Irritable Bowel Syndrome (IBS), a condition that can cause symptoms like stomach pain, bloating, and changes in bowel habits. The low FODMAP diet focuses on reducing certain types of carbohydrates that can be difficult for some people to digest. Researchers want to see if this diet can help improve symptoms, especially in those who experience diarrhea as a main issue.

To participate in the trial, you need to be between 18 and 65 years old and have been experiencing significant IBS symptoms. You should not have any other serious health conditions, like celiac disease or diabetes, and you shouldn’t have been on a low FODMAP diet or certain medications in the past few months. If you join the trial, you'll likely need to keep track of your symptoms and follow the low FODMAP diet for a set period. This study is currently active but not looking for new participants at the moment. It aims to provide more insight into how diet affects IBS and could help improve treatment options for those affected by this condition.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • aged 18-65 years at the time of screening
  • normal serum studies including serum tissue-transglutaminase antibodies, thyroid stimulating hormone levels, C-reactive protein, complete blood count since the onset of symptoms
  • normal stool studies including C diff testing, culture, ova and parasites since the onset of symptoms
  • IBS-SSS score of ≥175 at the end of 7-day screening period
  • Exclusion criteria:
  • individuals already on a LFD or other dietary restriction such as gluten free diet within the past 6 months
  • individuals with any known food allergy or insulin-dependent diabetes
  • known history of celiac disease, inflammatory bowel disease or microscopic colitis
  • prior small bowel or colonic surgery or cholecystectomy
  • pregnant patients
  • antibiotics in the past 3 months
  • those who regularly use mast cell stabilizers or anti-histaminic or non-steroidal anti-inflammatory agents (NSAIDs) excluding daily baby aspirin or steroids or bile-acid binder.

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center (BIDMC) is a leading academic medical center located in Boston, Massachusetts, affiliated with Harvard Medical School. Renowned for its commitment to cutting-edge research and innovation in healthcare, BIDMC fosters a collaborative environment that integrates patient care, education, and scientific investigation. The center actively sponsors clinical trials across a variety of disciplines, aiming to advance medical knowledge and improve patient outcomes. With a focus on translational medicine, BIDMC's research initiatives engage multidisciplinary teams to address complex health challenges and translate findings into effective therapeutic strategies.

Locations

Ann Arbor, Michigan, United States

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Judy Nee, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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