Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05941650
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-05
First Post:
2023-07-03
Brief Title:
To Study the Effect of Short-chain Fructooligosaccharides in Women With Irritable Bowel Syndrome
Sponsor:
Universidad Autonoma de Chihuahua
Organization:
Universidad Autonoma de Chihuahua
Study Overview
Official Title:
To Study the Clinical Effect After Administration of Short-chain Fructooligosaccharides in Women Aged 18 to 65 Years With a Diagnosis of Irritable Bowel Syndrome at the Central State Hospital A Randomized Single-blind Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
To evaluate whether there is clinical improvement through the scales Bristol IBS severity score and IBS quality of life in women with irritable bowel syndrome after administration of SC-FOS short-chain fructooligosaccharides
Detailed Description:
Patients will be selected according to the inclusion and exclusion criteria of the study population for randomization into two groups one group will be administered short-chain Fructooligosaccharides at a dose of 12 gr every 24 hours and the other group will be administered corn starch as a placebo for 10 daysThe protocol will be discussed with the patients andor relatives of the patients who will understand the consequences and advantages of the study and will sign the informed consent It should be specified to each patient andor family member that their participation in the protocol will not generate any extra cost for the administration of SC-FOS and furthermore that no reward of any kind will be granted for their participation in the protocolOnce informed consent has been obtained the preparation placebo or not will be delivered to the surgery department of the Central State Hospital It will come in bags in which the content can be visualized 10 pieces in total one for each day numbered according to the folio obtained by the corresponding randomization It should be emphasized that neither the patient nor the surgery department will know which is a placebo and which contains SC-FOSThere will be a placebo control group and a group that will be administered 12g of SC-FOS which should be diluted in 250 ml and taken daily for 10 days Before starting the administration of SC-FOS or placebo data will be collected on each patient Bristol Scale IBS severity score to evaluate severity IBS quality of life age physical activity drugs food restriction time of diagnosis of IBS etc
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