An interventional study of Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc, and Placebo in Antibiotic-associated Diarrhea, sponsored by University of Padova. Enrolling by invitation at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by University of Padova · Not applicable, Interventional, and Treatment
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.
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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 50 is below the median of 137 across 738 interventional studies indexed under Diarrhea.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group1: 2 capsules/day of DBZ (1 /morning and 1 /evening, away from meals) for 14 gg
Dietary Supplement: Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc,
Group2: 2 capsules/day of Placebo (1 /morning and 1 /evening, away from meals) for 14 gg
Dietary Supplement: Placebo
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.
The intervention with Placebo involves the intake of a product free of bityrate, zinc and vitD
Evaluation of the variation of gut microbiota composition (microbiota test)
Collection of faecal sample for the assessment of the faecal microbiota composition ( rRNA16S) The 16S rRNA gene is a bacterial ribosomal gene and a part of the 30S subunit which is used in the identification, characterization, and classification of various bacteria. Samples were normalized, pooled, and run on Illumina MiSeq , in order to evaluate the composition of gut microbiota in terms of bacterial diversity ( alfa and beta) and abundance and any variability associated with the treatment.
Time frame: 9 months
Evaluation of gastrointestinal symptoms ( VAS scale)
The patient will report the gastrointestinal symptoms on a form ( VAS scale), daily
Time frame: 9 months
Assessment of prevention of Antibiotic-associated diarrhea
The patient will report on a form the diarrheal episodes, using a scale from 1 to 10, daily.
Time frame: 9 months
Evaluation of psychological state and quality of life ( SF-12)
The patient will report a questionnaire (SF-12) on the quality of life at the visits.
Time frame: 9 months
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