NCT06982703

Evaluation of Butyrate Effect on Diarrhea

Evaluation of Butyrate, Zinc and Vitamine D Effect on Microbiota Modulation and Prevention of Antibiotic-associated Diarrhea

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the effects of a Food Supplement containing calcium butyrate, vitamin D, and zinc, on the variation of intestinal microbiota and prevention of antibiotic-induced diarrhea, in individuals who have been prescribed antibiotic therapy. The main questions it aims to answer is: Does Dibuzin improve the microbiota composition in patients undergoing antibiotic treatment? Does Dibuzin prevent antibiotic-induced diarrhea? Participants will: - take 2 capsules/day of DBZ (1 /morning and 1 /evening, away from meals) for 14 gg. -Visit the clinic two times ( T0 and at the end), collect three fecal samples, and fill out two questionnaires 3 times.

Detailed description

Antibiotic-associated diarrhea (AAD) is an important morbidity resulting from antibiotic use. AAD is more than a bothersome adverse event of antibiotic treatment; it is associated with prescription noncompliance and overuse of second-line antibiotics. Any antibiotic could potentially cause AAD, but broad-spectrum antibiotics that predominantly target anaerobes and are poorly absorbed, have a higher AAD incidence. Alterations in the diversity of the gut microbiota are believed to underlie the development of antibiotic-associated diarrhea, likewise, micronutrient deficiencies can exacerbate both barrier leak and morbidity. The use of SCFAs, such as butyrate, along with vitamin D and zinc, each possessing unique properties that contribute to enhancing the microbiota, controlling inflammation, and promoting a healthy intestinal barrier, may be beneficial in the prevention of AAD. The proposed dietary supplement contains butyrate, vitamin D, and zinc, and is presented as a potential product useful in the prevention of AAD.

Conditions

• Antibiotic-associated Diarrhea

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc,	In this prospective pilot study, we plan to evaluate the effects of a Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc, on the variation of intestinal microbiota and prevention of antibiotic-induced diarrhea, in individuals who have been prescribed antibiotic therapy.
DIETARY_SUPPLEMENT	Placebo	The intervention with Placebo involves the intake of a product free of bityrate, zinc and vitD

Timeline

• Start date: 2024-06-15
• Primary completion: 2025-12-31
• Completion: 2026-06-15
• First posted: 2025-05-21
• Last updated: 2025-05-21

Locations

1 site across 1 country: Italy