Evaluation of Butyrate Effect on Diarrhea (DBZ)

University of Padova

Status: Invitation-only

Conditions: Antibiotic-associated Diarrhea

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06982703

5907/AO/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Dibuzin

Active Comparator group

Description:

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

Treatment:

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

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo