Evaluation of Butyrate Effect on Diarrhea
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc,, Placebo.
- Who it may be relevant to
- Registry conditions: Antibiotic-associated Diarrhea. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Butyrate, Zinc and Vitamine D Effect on Microbiota Modulation and Prevention of Antibiotic-associated Diarrhea
Overview
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.
Interventions
- Dietary supplement 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. - Dietary supplement Placebo
The intervention with Placebo involves the intake of a product free of bityrate, zinc and vitD
Primary outcome measures
- Evaluation of the variation of gut microbiota composition (microbiota test) [Time frame: 9 months]
Secondary outcome measures (3)
- Evaluation of gastrointestinal symptoms ( VAS scale) [Time frame: 9 months]
- Assessment of prevention of Antibiotic-associated diarrhea [Time frame: 9 months]
- Evaluation of psychological state and quality of life ( SF-12) [Time frame: 9 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Edoardo V. Savarino — Padova
Identifiers
NCT: NCT06982703 · 5907/AO/24