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OpenTrials
Enrolling by Invitation

NCT Number: NCT06982703

Evaluation of Butyrate Effect on Diarrhea

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Edoardo V. Savarino

Padova, 35128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Dietary Supplement

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

Primary outcomes

  1. Evaluation of the variation of gut microbiota composition (microbiota test)

    Time frame: 9 months

    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.

Secondary outcomes

  1. Evaluation of gastrointestinal symptoms ( VAS scale)

    Time frame: 9 months

    The patient will report the gastrointestinal symptoms on a form ( VAS scale), daily

  2. Assessment of prevention of Antibiotic-associated diarrhea

    Time frame: 9 months

    The patient will report on a form the diarrheal episodes, using a scale from 1 to 10, daily.

  3. Evaluation of psychological state and quality of life ( SF-12)

    Time frame: 9 months

    The patient will report a questionnaire (SF-12) on the quality of life at the visits.

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Acronym: DBZ

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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