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Search / Trial NCT06432569

Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients (B/P3_1)

Launched by UNIVERSITY OF PADOVA · May 21, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon, characterized by relapsing and remitting mucosal inflammation. It presents with symptoms like bloody diarrhea, rectal urgency, fatigue, and abdominal pain. While various therapies are available for managing UC, including medications like amino salicylates, corticosteroids, immunomodulators, and biologics, there's ongoing research into supportive treatments like probiotics.

Probiotics are beneficial microorganisms that can positively influence gut health by modifying the gut microbiota, improving intestinal bar...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • ● IBS patients (both males and females) with positive diagnosis based on Rome IV criteria (IBS-D and IBS-M)
  • Age in the range 18-70 years
  • Subjects capable of conforming to the study protocol
  • Subjects who have given their free and informed consent
  • Exclusion Criteria:
  • -Any relevant organic, systemic or metabolic disease, including celiac disease, IDDM (Insulin- Dependant Diabetes Mellitus), Insulin-Independent Diabetes Mellitus, metabolic syndrome, pelvic organ prolapses, urinary incontinence, ulcerative colitis, Crohn's disease, microscopic colitis, infectious colitis, ischemic colitis, complicated diverticular disease.
  • Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
  • Prior major gastrointestinal surgeries
  • Females of childbearing potential, in the absence of effective contraceptive methods
  • Subjects who become unable to conform to protocol
  • Subjects who are continuously taking contact laxatives
  • Subjects who are treated continuously with glucocorticoids, anti-histaminergic and mast cell stabilizer drugs
  • Subjects who are treated continuously with trimebutine
  • Recent history or suspicion of alcohol abuse or drug addiction
  • Subjects who are treated with antibiotics or probiotics

About University Of Padova

The University of Padova, a prestigious research institution in Italy, is dedicated to advancing medical science through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration and cutting-edge research, the university fosters an environment conducive to the development of novel therapies and treatment modalities. Its commitment to ethical standards, patient safety, and scientific rigor ensures that all clinical trials are conducted with the highest level of integrity. Through these initiatives, the University of Padova aims to contribute significantly to the global medical community and improve health outcomes.

Locations

Padua, , Italy

Patients applied

0 patients applied

Trial Officials

Edoardo Savarino, Prof,MD

Principal Investigator

University of Padova

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported