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Trial Title:
To Study the Effect of SC-FOS Prebiotics in Women With Polycystic Ovary Syndrome
NCT ID:
NCT05999097
Condition:
Polycystic Ovary Syndrome
Conditions: Official terms:
Polycystic Ovary Syndrome
Syndrome
Conditions: Keywords:
Polycystic Ovary Syndrome
Prebiotics
Enteral Diet
Clinical Manifestations
SC-FOS
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Prospective study, randomized single blind clinical trial
Primary purpose:
Treatment
Masking:
Single (Participant)
Masking description:
Single (Participant)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Short Chain Fructooligosaccharides
Description:
The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr.
every 24 hours diluted in 250 ml of water.
Arm group label:
Short Chain Fructooligosaccharides Group
Other name:
Prebiotics
Intervention type:
Dietary Supplement
Intervention name:
Placebo Group
Description:
This group will receive 12 g of corn starch as a control group.
Arm group label:
Placebo Group
Other name:
Placebo
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 and/or 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Female sex
- Age 18 to 65 years
- Polycystic Ovary Syndrome diagnosed by specialist
- Useful enteral feeding
Exclusion Criteria:
- Pregnancy
- Diabetes mellitus
- Risk of intestinal perforation
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hospital Central del Estado de Chihuahua
Address:
City:
Chihuahua
Zip:
31000
Country:
Mexico
Status:
Recruiting
Contact:
Last name:
Carolina MartÃnez Loya, M.D.
Phone:
+526143543923
Email:
caromtzloya@gmail.com
Contact backup:
Last name:
Ruth S Favela Ortiz
Phone:
6142277559
Phone ext:
+52
Email:
rfavelaortiz@gmail.com
Start date:
December 2, 2024
Completion date:
May 30, 2025
Lead sponsor:
Agency:
Universidad Autonoma de Chihuahua
Agency class:
Other
Source:
Universidad Autonoma de Chihuahua
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05999097
