Evaluation of Butyrate Effect on Diarrhea

NCT ID: NCT06982703

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-15
• Study Completion Date: 2026-06-15

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.

Conditions

Antibiotic-associated Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dibuzin

Group1: 2 capsules/day of DBZ (1 /morning and 1 /evening, away from meals) for 14 gg

Group Type: ACTIVE_COMPARATOR

Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc,

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo

Group2: 2 capsules/day of Placebo (1 /morning and 1 /evening, away from meals) for 14 gg

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

The intervention with Placebo involves the intake of a product free of bityrate, zinc and vitD

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

The intervention with Placebo involves the intake of a product free of bityrate, zinc and vitD

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Padova

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edoardo V. Savarino, medical doctor, PhD

Role: PRINCIPAL_INVESTIGATOR

UniPD-AOUP

Locations

Edoardo V. Savarino

Padua, , Italy

Countries

Italy

Other Identifiers

5907/AO/24

Identifier Type: -

Identifier Source: org_study_id