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

• Sponsor: Universidad Autonoma de Chihuahua (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05941650
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Days): 29

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Syndrome; Diarrhea- Irritable Bowel Syndrome; Constipation-predominant Irritable Bowel Syndrome	Dietary Supplement: Short Chain Fructooligosaccharides; Other: Corn Starch	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective study, randomized single blind clinical trialProspective study, randomized single blind clinical trial
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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.
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 10, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Score of IBS-QOL [10 days]

   Score obtained in the questionnaire Irritable Bowel Syndrome - Quality of Life

2. Score of Bristol Scale [10 days]

   Score obtained by Stool Consistency Bristol Scale

3. Score of IBS-SSS [10 days]

   Score obtained in the questionnaire Irritable Bowel Syndrome - Severity Scoring System

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universidad Autonoma de Chihuahua

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carolina Martínez Loya, MD, Médico Pasante de Servicio Social, Universidad Autonoma de Chihuahua
• ClinicalTrials.gov Identifier: NCT05941650
• Other Study ID Numbers: 029C-06/23
• First Posted: Jul 12, 2023
• Last Update Posted: Jul 12, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Carolina Martínez Loya, MD, Médico Pasante de Servicio Social, Universidad Autonoma de Chihuahua: Irritable Bowel Syndrome; SC-FOS; Prebiotics
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation; Diarrhea

Study Results

No Results Posted as of Jul 12, 2023