Antibiotic-associated Diarrhea
Conditions
Keywords
antibiotics, microbiota, diarrhea
Brief 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. 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_SUPPLEMENTFood 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_SUPPLEMENTPlacebo
The intervention with Placebo involves the intake of a product free of bityrate, zinc and vitD
Sponsors
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the variation of gut microbiota composition (microbiota test) | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of prevention of Antibiotic-associated diarrhea | 9 months | The patient will report on a form the diarrheal episodes, using a scale from 1 to 10, daily. |
| Evaluation of psychological state and quality of life ( SF-12) | 9 months | The patient will report a questionnaire (SF-12) on the quality of life at the visits. |
| Evaluation of gastrointestinal symptoms ( VAS scale) | 9 months | The patient will report the gastrointestinal symptoms on a form ( VAS scale), daily |
Countries
Italy
Outcome results
None listed