Evaluation of Butyrate Effect on Diarrhea

NCT06982703 | Enrolling By Invitation

• 1 other identifier: 5907/AO/24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Antibiotic-associated Diarrhea

Keywords

antibiotics, microbiota, diarrhea

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Evaluation of gastrointestinal symptoms ( VAS scale)

  9 months

• Assessment of prevention of Antibiotic-associated diarrhea

  9 months

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

  9 months

Study Arms (2)

Dibuzin

ACTIVE COMPARATOR

Group1: 2 capsules/day of DBZ (1 /morning and 1 /evening, away from meals) for 14 gg

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

Dietary Supplement: Placebo

Interventions

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.

Dibuzin

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects undergoing antibiotic therapy
• Subjects capable of conforming to the study protocol
• Subjects who have given their free and informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Padova: lead

Study Sites (1)

Edoardo V. Savarino

Padua, 35128, Italy

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Vitamin D; Zinc

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Edoardo V. Savarino, medical doctor, PhD

  UniPD-AOUP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: June 15, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 21, 2025

Record last verified: 2024-09

Locations

IT (1)