Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432569
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-29
First Post:
2023-02-27
Brief Title:
Evaluation of Butyrate and Palmitoylethanolamide in IBS Patients BP3_1
Sponsor:
University of Padova
Organization:
University of Padova
Study Overview
Official Title:
Evaluation of Butyrate and Palmitoylethanolamide Effects on Intestinal Permeability and Microbiota Gut Composition in Patients With Irritable Bowel Syndrome - A Double-blind Placebo-controlled Crossover Randomized Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BP3_1
Brief Summary:
Evaluation of the effects of butyrate BitirBioma and palmitoylethanolamide PEAPeaBioma on intestinal permeability and gut microbiota composition in patients with irritable bowel syndrome
Study BP 3_1 is an interventional study involving the use of food supplements on the market BitirBioma Plus and PeaBioma Plus single-center double-blind placebo-controlled crossover randomized in n50 patients with bowel syndrome irritable diarrheal and mixed variant IBS-D and IBS-M lasting for one year
The study has two arms Group 1 n25 Treatment A e Group 2 n25 Treatment B with - Treatment A 3 capsulesday of butyrate 625 mg 3 capsulesday PEA 200 mg at a ratio of dosage of 31 - Treatment B Placebo 33day capsules of starch
Eligible subjects with IBS will be randomized in a 11 ratio to treatment A or treatment B for six weeks After the first treatment period there is a 14-day washout period
Hence individuals will be treated with BA treatment for additional six weeks according to the crossover design
In the two treatment periods subjects will be required to complete a visual analogue score VAS questionnaire to assess gastrointestinal symptoms and Stool Bristol Scales During the visit the subjects will have to record Questionnaire Rome IV to evaluate their quality of life At the same time it will be theirs required to provide
fecal sample for the evaluation of the composition of fecal microbiota Biomaplan Kit
a urine sample for the evaluation of intestinal permeability Gastropack a capillary blood sample and a serum sample for the detection of Zonulin Kit Healthy gut and Immundiagnostik AG
a capillary blood sample and a serum sample for the detection of Zonulin Kit Healthy gut and Immundiagnostik AG
Study BP 3_1 is an interventional study involving the use of food supplements on the market BitirBioma Plus and PeaBioma Plus single-center double-blind placebo-controlled crossover randomized in n50 patients with bowel syndrome irritable diarrheal and mixed variant IBS-D and IBS-M lasting for one year
The study has two arms Group 1 n25 Treatment A e Group 2 n25 Treatment B with - Treatment A 3 capsulesday of butyrate 625 mg 3 capsulesday PEA 200 mg at a ratio of dosage of 31 - Treatment B Placebo 33day capsules of starch
Eligible subjects with IBS will be randomized in a 11 ratio to treatment A or treatment B for six weeks After the first treatment period there is a 14-day washout period
Hence individuals will be treated with BA treatment for additional six weeks according to the crossover design
In the two treatment periods subjects will be required to complete a visual analogue score VAS questionnaire to assess gastrointestinal symptoms and Stool Bristol Scales During the visit the subjects will have to record Questionnaire Rome IV to evaluate their quality of life At the same time it will be theirs required to provide
fecal sample for the evaluation of the composition of fecal microbiota Biomaplan Kit
a urine sample for the evaluation of intestinal permeability Gastropack a capillary blood sample and a serum sample for the detection of Zonulin Kit Healthy gut and Immundiagnostik AG
a capillary blood sample and a serum sample for the detection of Zonulin Kit Healthy gut and Immundiagnostik AG
Detailed Description:
Ulcerative colitis UC is a chronic inflammatory condition affecting the colon characterized by relapsing and remitting mucosal inflammation It presents with symptoms like bloody diarrhea rectal urgency fatigue and abdominal pain While various therapies are available for managing UC including medications like amino salicylates corticosteroids immunomodulators and biologics theres ongoing research into supportive treatments like probiotics
Probiotics are beneficial microorganisms that can positively influence gut health by modifying the gut microbiota improving intestinal barrier function and balancing immune response Several studies have investigated their efficacy in UC management Notably the probiotic mixture VSL3 containing strains of Lactobacillus and Bifidobacteria has shown promising results in inducing remission in UC patients
Other probiotic products like E coli Nissle 1917 L rhamnosus GG and L casei DG have also demonstrated effectiveness in maintaining disease remission or prolonging relapse-free periods in UC patients The product Prolife 10 FORTE containing multiple strains of Lactobacillus Bifidobacteria and Bacillus coagulans along with prebiotic components and vitamins has shown potential in positively influencing gut microbiota composition and metabolic activity in healthy individuals
Based on these promising findings further investigation is warranted to evaluate the potential of Prolife 10 FORTE in improving the gut microbiota composition of UC patients during the remission phase
Probiotics are beneficial microorganisms that can positively influence gut health by modifying the gut microbiota improving intestinal barrier function and balancing immune response Several studies have investigated their efficacy in UC management Notably the probiotic mixture VSL3 containing strains of Lactobacillus and Bifidobacteria has shown promising results in inducing remission in UC patients
Other probiotic products like E coli Nissle 1917 L rhamnosus GG and L casei DG have also demonstrated effectiveness in maintaining disease remission or prolonging relapse-free periods in UC patients The product Prolife 10 FORTE containing multiple strains of Lactobacillus Bifidobacteria and Bacillus coagulans along with prebiotic components and vitamins has shown potential in positively influencing gut microbiota composition and metabolic activity in healthy individuals
Based on these promising findings further investigation is warranted to evaluate the potential of Prolife 10 FORTE in improving the gut microbiota composition of UC patients during the remission phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None