- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04879914
Analysis of Microbiota Changes Induced by Microencapsulated Sodium Butyrate in Patients With Inflammatory Bowel Disease (IBDMicro)
Inflammation and Intestinal Microbiota Modulation in Inflammatory Bowel Diseases
Inflammatory bowel disease (IBD) is characterized by severe inflammation of the small bowel and/or the colon leading to recurrent diarrhea and abdominal pain.
Irritable Bowel Syndrome with diarrhea (IBS-D) is characterized by abdominal pain or discomfort, gas, loose and frequent stools.
Butyrate has shown anti-inflammatory and regenerative properties, providing symptomatic relief when orally supplemented in patients suffering from various colonic diseases. The investigator proposes to investigate the effect of a microencapsulated form of sodium butyrate on the fecal microbiota of patients with IBD and IBS-D.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Padua, Italy, 35128
- Edoardo Vinvenzo Savarino
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with histologically confirmed diagnosis of Crohn disease (CD) or Ulcerative colitis (UC) in the last 6 months and undergoing followup colonoscopy.
Exclusion Criteria:
- (a) prior proctocolectomy;
- (b) presence of IBD extraintestinal manifestation;
- (c) treatment with antibiotics in the last 60 days;
- (d) extensive surgical resection;
- (e) presence of stoma.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Butyrate
Patients taking butyrate
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3 cps/die 300 mg/cps
Other Names:
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Experimental: Placebo
Patients taking placebo
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3 cps/die 300 mg/cps
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
NGS analysis ( 16S rRNA) will be used to highlight the microbiota variation induced by Butyrose/Placebo administration in 160 IBD and 40 IBS-D patients after 8 weeks of treatment.
Time Frame: 90 days
|
The 16S rRNA is a fundamental component of the prokaryotic ribosome, where defines structural and functional properties interacting for example with the mRNA. Its structure and sequences were characterized during the 70's/80's, and the corresponding DNA coding sequence is referred to 16s rRNA gene. The 16s rRNA gene started to be used as the phylogenetic marker in the 70's due to its ubiquity among bacterial kingdom, allowing comparison between evolutionarily distant organisms. A new oral formulation of sodium-butyrate, at the dose of 3 capsules/d (1800 mg/d), will be administered, during the main meals, in consecutive IBD or IBS-D patients, for 90 days. At the same time, a control group will receive three starch capsules with similar color, flavor, and size. |
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment effects on clinical activity by fecal calprotectin.
Time Frame: 90 days
|
Analysis of fecal calprotectin will be evaluated by clinical routinary analysis before and after treatment with Butyrose/Placebo.
The Butyrose treatment at the dose of 3 capsules/die, will be administered in consecutive IBD and IBS-D patients, for 90 days.
At the same time, a control group received three starch capsules with similar color, flavor, and size.
|
90 days
|
Treatment effects on lifestyle by IBD Questionaire.
Time Frame: 90 days
|
The IBD questionnaire is a disease-specific questionnaire to highlight the patients' lifestyle before and after treatment.
The IBDQ analysis will be performed as described in Yarlas A. et al.;J Patient Cent Res Rev 2020 10.17294/2330-0698.1722
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edoardo V. Savarino, Prof. MD, PhD, Department of Surgery, Oncology and Gastroenterology - DiSCOG University of Padua - Azienza Ospedaliera di Padova
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4049/AO/17
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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