Antibiotic-associated DiarrheaDBZNCT06982703
Evaluation of Butyrate Effect on Diarrhea
A study testing Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc, in people with Antibiotic-associated Diarrhea, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Antibiotic-associated Diarrhea
- What is being tested?
- Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc,
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2024to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing antibiotic therapy
- Subjects capable of conforming to the study protocol
- Subjects who have given their free and informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Butyrate, Zinc and Vitamine D Effect on Microbiota Modulation and Prevention of Antibiotic-associated 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.
Read the 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
- Being tested
- Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc,, Placebo
- Keywords
- antibiotics, microbiota, diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
PlaceboDietary supplement
The intervention with Placebo involves the intake of a product free of bityrate, zinc and vitD
| Study group | Role | What they receive |
|---|---|---|
| Dibuzin | Active comparator | Group1: 2 capsules/day of DBZ (1 /morning and 1 /evening, away from meals) for 14 gg Receives: Dietary Supplement: Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc, |
| Placebo | Placebo comparator | Group2: 2 capsules/day of Placebo (1 /morning and 1 /evening, away from meals) for 14 gg Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (3)
Evaluation of gastrointestinal symptoms ( VAS scale)
The patient will report the gastrointestinal symptoms on a form ( VAS scale), daily
Measured: 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.
Measured: 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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start15 Jun 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, placebo-controlled, randomized trial, in which the enrolled subjects will be included in one year. After enrolment and written informed consent collection, 50 subjects will be randomized in a 1:1 ratio to Group 1 or Group 2 . During the study supplement administration subjects will be requested to avoid probiotics, while only fermented foods normally consumed will be allowed
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edoardo V. Savarino, medical doctor, PhD, Principal investigator, UniPD-AOUP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982703
- Sponsor's protocol ID
- 5907/AO/24
- Acronym
- DBZ
- Status last verified
- Sep 2024
- First submitted
- 13 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Butyrate, Zinc and Vitamine D Effect on Microbiota Modulation and Prevention of Antibiotic-associated Diarrhea
- ClinicalTrials.gov ID
- NCT06982703
- Acronym / sponsor ID
- DBZ / 5907/AO/24
- Conditions
- Antibiotic-associated Diarrhea
- Keywords
- antibiotics, microbiota, diarrhea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This is a double-blind, placebo-controlled, randomized trial, in which the enrolled subjects will be included in one year. After enrolment and written informed consent collection, 50 subjects will be randomized in a 1:1 ratio to Group 1 or Group 2 . During the study supplement administration subjects will be requested to avoid probiotics, while only fermented foods normally consumed will be allowed
| Arm | Type | Receives |
|---|---|---|
| Dibuzin | Active comparator | Dietary Supplement: Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc,Group1: 2 capsules/day of DBZ (1 /morning and 1 /evening, away from meals) for 14 gg |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboGroup2: 2 capsules/day of Placebo (1 /morning and 1 /evening, away from meals) for 14 gg |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects undergoing antibiotic therapy
- Subjects capable of conforming to the study protocol
- Subjects who have given their free and informed consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dibuzin |
| PlaceboThe intervention with Placebo involves the intake of a product free of bityrate, zinc and vitD | Dietary supplement | Placebo |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edoardo V. Savarino, medical doctor, PhD principal investigator
UniPD-AOUP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Supplement DBZ (acronym for: DIBUZIN) containing calcium butyrate, vitamin D and zinc, in people with Antibiotic-associated Diarrhea, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the variation of gut microbiota composition (microbiota test) (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.