Clinical trial NCT06982703: Evaluation of Butyrate Effect on Diarrhea
Official title: Evaluation of Butyrate, Zinc and Vitamine D Effect on Microbiota Modulation and Prevention of Antibiotic-associated Diarrhea
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Antibiotic-associated Diarrhea
Keywords: antibiotics, microbiota, diarrhea
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind, placebo-controlled, randomized trial, in which the enrolled subjects will be included in one year. After enrolment and written informed consent collection, 50 subjects will be randomized in a 1:1 ratio to Group 1 or Group 2 . During the study supplement administration subjects will be requested to avoid probiotics, while only fermented foods normally consumed will be allowed
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing antibiotic therapy
* Subjects capable of conforming to the study protocol
* Subjects who have given their free and informed consent

Exclusion Criteria:

* Subjects with untreated food intolerance, i.e. remaining symptomatic despite the withdrawal of the suspected food
* Subjects who become unable to conform to protocol
* Subjects who are continuously taking contact laxatives Subjects who are treated with pre/probiotics

Primary outcomes:
measure: Evaluation of the variation of gut microbiota composition (microbiota test)
timeFrame: 9 months
Secondary outcomes:
measure: Evaluation of gastrointestinal symptoms ( VAS scale)
timeFrame: 9 months
measure: Assessment of prevention of Antibiotic-associated diarrhea
timeFrame: 9 months
measure: Evaluation of psychological state and quality of life ( SF-12)
timeFrame: 9 months
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Edoardo V. Savarino
Study officials:
affiliation: UniPD-AOUP
name: Edoardo V. Savarino, medical doctor, PhD
role: PRINCIPAL_INVESTIGATOR
References: