Clinical trial NCT05999097: To Study the Effect of SC-FOS Prebiotics in Women With Polycystic Ovary Syndrome
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic Ovary Syndrome
Prebiotics
Enteral Diet
Clinical Manifestations
SC-FOS
Lead sponsor: Universidad Autonoma de Chihuahua
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective study, randomized single blind clinical trial
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Score of Bristol Scale
timeFrame: 10 days
measure: Score Short Form Health Survey (SF-36)
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chihuahua
country: Mexico
facility: Hospital Central del Estado de Chihuahua
Study officials:
affiliation: Universidad Autonoma de Chihuahua
name: Luis B Enríquez-Sánchez
role: STUDY_DIRECTOR
References: