Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04760353
Status:
RECRUITING
Last Update Posted:
2024-01-08
First Post:
2021-01-26
Brief Title:
The Effect of a Probiotic Mixture in Obese Patients With Irritable Bowel Syndrome
Sponsor:
University Hospital Rijeka
Organization:
University Hospital Rijeka
Study Overview
Official Title:
The Effect of a Probiotic Mixture on the Symptoms and Fecal Microbiota in Obese Patients With Irritable Bowel Syndrome Randomised Double-blind Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
None
Brief Summary:
The objective of the current study is to evaluate the effect of a probiotic mixture on the adequate relief and faecal microbiota in obese patients with irritable bowel syndrome
Detailed Description:
The treatment period will last 8 weeks and after the treatment period patients will be followed-up for another 2 weeks Thus the overall trial period is the 10-week study period and end of 10th week is the end of the trial
Planned visits to gastroenterologists are at the screening period -1 week randomization period 0 weeks and at the end of the treatment period 8th week
Patients will be instructed that unplanned visits to gastroenterologist are allowed only in case of a need or an urgency eg adverse reactions clinical deterioration andor need for additional irritable bowel syndrome IBS management Unplanned visits will be recorded and does not exclude patients from the trial
For assessing other needed parameters eg adequate relief adverse reactions irritable bowel syndrome IBS management patients will be assessed by a physician using an interactive voice response by telephone
Laboratory tests will be performed by certified clinical laboratories Blood samples will be obtained by experienced trial nurses at the time of randomization 0 weeks
Anthropometric measurements will be assessed at the baseline and at the end of the treatment period 8th week
Irritable bowel syndrome IBS management non-medication and medication therapy will be assessed at the baseline during the trial at the planned and unplanned visits to gastroenterologists and at the end of the trial by a physician using an interactive voice response by telephone In a case of clinical deterioration IBS management is allowed during the trial and each will be recorded by gastroenterologists
Participants will receive 112 powder portion bags at the beginning of the trial and will be instructed to return the container after the 8-week treatment period Leftover powder portion bags will be counted at the end of the treatment period 8th week to estimate compliance Compliant is considered a participant where no leftover powder portion bags will be recorded Otherwise the participant is considered non-compliant
Safety will be ensured by following adverse reactions during the trial Scheduled assessment of adverse reactions is at the time of randomization after 4 weeks 8 weeks and at the end of the trial Responses will be recorded by a physician at the planned visit of gastroenterologists andor using an interactive voice response by telephone Unscheduled recording of adverse reactions is during the entire trial by patients which will be instructed at the randomization period to report any adverse reactions to gastroenterologists using an interactive voice response by telephone In a case of severe adverse reactions patients will be withdrawn from the trial and if needed In case of a need or urgency eg adverse reactions clinical deterioration clinical management will be provided in line with the best medical practice by gastroenterologists andor medical specialists depending on a medical condition
Patients can withdrawal from the trial any time During the trial period withdrawal and its reason will be assessed by gastroenterologists at the visits or using an interactive voice response by telephone Patients will be instructed in a case of a withdrawal to inform gastroenterologists and report the reason In a lack of response the reason will be considered as other
Planned visits to gastroenterologists are at the screening period -1 week randomization period 0 weeks and at the end of the treatment period 8th week
Patients will be instructed that unplanned visits to gastroenterologist are allowed only in case of a need or an urgency eg adverse reactions clinical deterioration andor need for additional irritable bowel syndrome IBS management Unplanned visits will be recorded and does not exclude patients from the trial
For assessing other needed parameters eg adequate relief adverse reactions irritable bowel syndrome IBS management patients will be assessed by a physician using an interactive voice response by telephone
Laboratory tests will be performed by certified clinical laboratories Blood samples will be obtained by experienced trial nurses at the time of randomization 0 weeks
Anthropometric measurements will be assessed at the baseline and at the end of the treatment period 8th week
Irritable bowel syndrome IBS management non-medication and medication therapy will be assessed at the baseline during the trial at the planned and unplanned visits to gastroenterologists and at the end of the trial by a physician using an interactive voice response by telephone In a case of clinical deterioration IBS management is allowed during the trial and each will be recorded by gastroenterologists
Participants will receive 112 powder portion bags at the beginning of the trial and will be instructed to return the container after the 8-week treatment period Leftover powder portion bags will be counted at the end of the treatment period 8th week to estimate compliance Compliant is considered a participant where no leftover powder portion bags will be recorded Otherwise the participant is considered non-compliant
Safety will be ensured by following adverse reactions during the trial Scheduled assessment of adverse reactions is at the time of randomization after 4 weeks 8 weeks and at the end of the trial Responses will be recorded by a physician at the planned visit of gastroenterologists andor using an interactive voice response by telephone Unscheduled recording of adverse reactions is during the entire trial by patients which will be instructed at the randomization period to report any adverse reactions to gastroenterologists using an interactive voice response by telephone In a case of severe adverse reactions patients will be withdrawn from the trial and if needed In case of a need or urgency eg adverse reactions clinical deterioration clinical management will be provided in line with the best medical practice by gastroenterologists andor medical specialists depending on a medical condition
Patients can withdrawal from the trial any time During the trial period withdrawal and its reason will be assessed by gastroenterologists at the visits or using an interactive voice response by telephone Patients will be instructed in a case of a withdrawal to inform gastroenterologists and report the reason In a lack of response the reason will be considered as other
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