To Study the Effect of Short-chain Fructooligosaccharides in Women With Irritable Bowel Syndrome

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.

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Irritable Bowel Syndrome; Constipation-predominant Irritable Bowel Syndrome; Diarrhea- Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Short Chain Fructooligosaccharides; Other: Corn Starch

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 days.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 sign the informed consent. It should be specified to each patient and/or 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 protocol.Once 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-FOS.There 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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carolina Martinez Loya; Phone Number: +526143543923; Email: caromtzloya@gmail.com
• Study Contact Backup: Name: Ruth S Favela Ortiz; Phone Number: +526142277559; Email: rfavelaortiz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Female sex
• Age 18 to 65 years
• Irritable Bowel Syndrome diagnosed by Rome Criterion
• Useful enteral feeding

Exclusion Criteria:

• Recent gastrointestinal disease < 2 weeks different to IBS
• Previous consumption of SC-FOS
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short Chain Fructooligosaccharides Group; This group will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours for 10 days, diluted in 250 ml	Dietary supplement: Short Chain Fructooligosaccharides; The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water.; Other Names: Prebiotics
Placebo Comparator: Group; This group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml	Other: Corn Starch; This group will receive 12 g of corn starch as a control group.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score of IBS-QOL	Score obtained in the questionnaire Irritable Bowel Syndrome - Quality of Life	10 days
Score of IBS-SSS	Score obtained in the questionnaire Irritable Bowel Syndrome - Severity Scoring System	10 days
Score of Bristol Scale	Score obtained by Stool Consistency Bristol Scale The seven types of stool are: 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) Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea.	10 days

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Chihuahua
• Investigators: Study Director: Luis B Enríquez Sánchez, Universidad Autonoma de Chihuahua

Study record dates

Study Major Dates

• Study Start (Estimated): December 2, 2024
• Primary Completion (Estimated): May 10, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: July 3, 2023
• First Submitted That Met QC Criteria: July 3, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Estimated): February 5, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Prebiotics; SC-FOS
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea; Constipation
• Other Study ID Numbers: 029C-06/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data obtained from this research study will be available if requested once the study is finalized.
• IPD Sharing Time Frame: The data will be available for up to five years since completion of the study.
• IPD Sharing Access Criteria: The request for the data will be by e-mail.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No