Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05999097
Status:
RECRUITING
Last Update Posted:
2024-02-05
First Post:
2023-08-11
Brief Title:
To Study the Effect of SC-FOS Prebiotics in Women With Polycystic Ovary Syndrome
Sponsor:
Universidad Autonoma de Chihuahua
Organization:
Universidad Autonoma de Chihuahua
Study Overview
Official Title:
To Study the Clinical Effect of SC-FOS Prebiotics in Enteral Diet vs Standard Enteral Diet on Clinical Characteristics of Patients With Polycystic Ovary Syndrome According to the Rotterdam Classification in Chihuahua Chihuahua A Randomized Single-Blind Clinical Trial
Status:
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:
The purpose of this study is to determine if there is a difference in the clinical characteristics of patients with polycystic ovary syndrome after the administration of SC-FOS in the enteral diet compared to patients with a standard diet
Detailed Description:
The protocol will be discussed with the patients andor relatives of the patients who will understand the consequences and advantages of the study and will thus sign the consent
Once informed consent has been obtained the group to which each patient belongs will be randomly assigned
Patients will be selected according to the inclusion and exclusion criteria of the population diagnosed with PCOS with useful enteral route for random assignment into two groups one will be administered short-chain Fructooligosaccharides at a dose of 12 g every 24 hours another group will be given saline as a placebo to the enteral diet every 24 hours for 10 days Patients should take the solution on an empty stomach
Once the type of intervention has been determined the patient will be given the suspensions corresponding to group 1 or placebo with vials in which the content cannot be visualized numbered according to the sheet obtained by the corresponding randomization The initial evaluation will be completed with all the clinical characteristics to be evaluated
The patient will be told that every 24 hours he must take 1 suspension on an empty stomach which will be prepared at a rate of 12 grams of SC-FOS in 15 cc of saline solution for the prebiotic preparation vs 15 cc of saline solution for the placebo group The solution will be administered enterally for 10 consecutive days at a single dose per day and a reassessment will be made on the seventh day of the clinical characteristics of the patients to compare and evaluate the results
Once informed consent has been obtained the group to which each patient belongs will be randomly assigned
Patients will be selected according to the inclusion and exclusion criteria of the population diagnosed with PCOS with useful enteral route for random assignment into two groups one will be administered short-chain Fructooligosaccharides at a dose of 12 g every 24 hours another group will be given saline as a placebo to the enteral diet every 24 hours for 10 days Patients should take the solution on an empty stomach
Once the type of intervention has been determined the patient will be given the suspensions corresponding to group 1 or placebo with vials in which the content cannot be visualized numbered according to the sheet obtained by the corresponding randomization The initial evaluation will be completed with all the clinical characteristics to be evaluated
The patient will be told that every 24 hours he must take 1 suspension on an empty stomach which will be prepared at a rate of 12 grams of SC-FOS in 15 cc of saline solution for the prebiotic preparation vs 15 cc of saline solution for the placebo group The solution will be administered enterally for 10 consecutive days at a single dose per day and a reassessment will be made on the seventh day of the clinical characteristics of the patients to compare and evaluate the results
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