To Study the Effect of SC-FOS Prebiotics in Women With Polycystic Ovary Syndrome

Not Applicable

Recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: Placebo Group; Dietary Supplement: Short Chain Fructooligosaccharides

• Registration Number: NCT05999097
• Lead Sponsor: Universidad Autonoma de Chihuahua

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.

Study Timeline

• Study First Submitted: 2023-08-11
• Study First Submitted QC: 2023-08-11
• Study First Posted: 2023-08-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-05
• Study Start: 2024-12-02
• Primary Completion: 2025-05-10
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo Group	This group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml
Short Chain Fructooligosaccharides Group	Short Chain Fructooligosaccharides	This group will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours for 10 days, diluted in 250 ml

Primary Outcome Measures

Name	Time	Method
Score of Bristol Scale	10 days	Score obtained by Stool Consistency Bristol Scale: This scale consist in seven types of stool: Type 1: Separate hard lumps, like nuts (difficult to pass) Type 2: Sausage-shaped, but lumpy Type 3: Like a sausage but with cracks on its surface Type 4: Like a sausage or snake, smooth and soft (average stool) Type 5: Soft blobs with clear cut edges Type 6: Fluffy pieces with ragged edges, a mushy stool (diarrhea) Type 7: Watery, no solid pieces, entirely liquid (diarrhea)
Score Short Form Health Survey (SF-36)	10 days	Short Form Health Survey (SF-36) is a measure of health-related quality-of-life: It comprises 36 questions that cover eight domains of health; 1. Limitations in physical activities because of health problems.; 2. Limitations in social activities because of physical or emotional problems; 3. Limitations in usual role activities because of physical health problems; 4. Bodily pain; 5. General mental health (psychological distress and well-being); 6. Limitations in usual role activities because of emotional problems; 7. Vitality (energy and fatigue); 8. General health perceptions

Trial Locations

Locations (1)

Hospital Central del Estado de Chihuahua; 🇲🇽 Chihuahua, Mexico