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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dibuzin | Active Comparator | Group1: 2 capsules/day of DBZ (1 /morning and 1 /evening, away from meals) for 14 gg |
|
| Placebo | Placebo Comparator | Group2: 2 capsules/day of Placebo (1 /morning and 1 /evening, away from meals) for 14 gg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of gastrointestinal symptoms ( VAS scale) | The patient will report the gastrointestinal symptoms on a form ( VAS scale), daily | 9 months |
| Assessment of prevention of Antibiotic-associated diarrhea |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edoardo V. Savarino, medical doctor, PhD | UniPD-AOUP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edoardo V. Savarino | Padova | 35128 | Italy |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D015032 | Zinc |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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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
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| Placebo | Dietary Supplement | The intervention with Placebo involves the intake of a product free of bityrate, zinc and vitD |
|
The patient will report on a form the diarrheal episodes, using a scale from 1 to 10, daily.
| 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. | 9 months |
| D019216 |
| Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |