Evaluation of Butyrate Effect on Diarrhea
NCT06982703 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-05-21
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
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
Sponsors & Collaborators
-
University of Padova
lead OTHER
Principal Investigators
-
Edoardo V. Savarino, medical doctor, PhD · UniPD-AOUP
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-15
- Primary Completion
- 2025-12-31
- Completion
- 2026-06-15
Countries
- Italy
Study Locations
More Related Trials
-
A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
NCT06582264 ·Status: COMPLETED ·Phase: PHASE1
-
Support of Colonization Resistance of the Gut Microbiota with the Synbiotic Food Supplement Nagasin®
NCT05800704 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Probiotics for the Prevention of Antibiotics Associated Diarrhoea and Clostridium Difficile Associated Diarrhoea
NCT00973908 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
NCT04335084 ·Status: COMPLETED ·Phase: PHASE2
-
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection
NCT02299570 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Bio-K+® in the Reduction of the Risk of Clostridium Difficile Infection and Antibiotic Associated Diarrhea
NCT01972932 ·Status: TERMINATED ·Phase: PHASE4
-
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
NCT02561195 ·Status: COMPLETED ·Phase: PHASE2
-
BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection
NCT01202630 ·Status: SUSPENDED ·Phase: PHASE3
-
Rifaximin Versus Placebo in the Prevention of Travelers' Diarrhea
NCT00098384 ·Status: COMPLETED ·Phase: PHASE2
-
Addition of Lactobacillus to Metronidazole in Treatment of CDAD
NCT00304863 ·Status: WITHDRAWN ·Phase: PHASE4
-
Effect of Bismuth Subsalicylate on the Gut Microbiome and Host Response in Healthy Adults
NCT05930197 ·Status: COMPLETED ·Phase: PHASE1
-
Vancomycin Prophylaxis in Recurrent Clostridium Difficile Infection
NCT02237859 ·Status: UNKNOWN ·Phase: PHASE4
-
Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection
NCT02686645 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Antiparasitic Treatment for Returning Travelers With Chronic Diarrhea
NCT01070277 ·Status: UNKNOWN ·Phase: NA
-
Safety and Clinical Effectiveness of Oral Probiotic MIYA-BM to Prevent Recurrent Clostridium Difficile Infections
NCT01077245 ·Status: WITHDRAWN ·Phase: PHASE2
-
Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCHCD3)
NCT03244644 ·Status: COMPLETED ·Phase: PHASE3
-
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
NCT02117570 ·Status: COMPLETED ·Phase: PHASE2
-
Prevention of Recurrence of Clostridioides Difficile Colitis With Ursodeoxycholic Acid (UCDA) as a Supplement to Standard Therapy
NCT06884748 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
Treatment of Recurrent Clostridium Difficile Infection With RBX7455
NCT02981316 ·Status: COMPLETED ·Phase: PHASE1
-
Bacillus Velezensis DSM 33864 for Reduction of the Risk of Recurrent Clostridioides Difficile Infections
NCT05606159 ·Status: WITHDRAWN ·Phase: NA
-
Fecal Transplant +/- Gut Decontamination in Preventing Acute Graft Versus Host Disease in Patients Given Broad-Spectrum Antibiotics
NCT03862079 ·Status: WITHDRAWN ·Phase: PHASE2
-
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
NCT02200328 ·Status: TERMINATED ·Phase: PHASE4
-
Octreotide in Preventing or Reducing Diarrhea in Patients Receiving Chemoradiotherapy for Anal or Rectal Cancer
NCT00075868 ·Status: COMPLETED ·Phase: PHASE3
-
Diverticulitis: Antibiotics or Close Observation?
NCT01111253 ·Status: UNKNOWN ·Phase: PHASE4
-
Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis
NCT02606032 ·Status: COMPLETED ·Phase: PHASE2