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

NCT ID: NCT05941650

Last Updated: 2024-02-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2025-05-30

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).

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.).

Conditions

Irritable Bowel Syndrome; Diarrhea- Irritable Bowel Syndrome; Constipation-predominant Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Short Chain Fructooligosaccharides

Intervention Type: DIETARY_SUPPLEMENT

The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water.

Group

This group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml

Group Type: PLACEBO_COMPARATOR

Corn Starch

Intervention Type: OTHER

This group will receive 12 g of corn starch as a control group.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Corn Starch

This group will receive 12 g of corn starch as a control group.

Intervention Type: OTHER

Other Intervention Names

Prebiotics; Placebo

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Autonoma de Chihuahua

OTHER

Sponsor Role: lead

Responsible Party

Carolina Martínez Loya, MD

Médico Pasante de Servicio Social

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luis B Enríquez Sánchez

Role: STUDY_DIRECTOR

Universidad Autonoma de Chihuahua

Central Contacts

Carolina Martinez Loya

Role: CONTACT

caromtzloya@gmail.com

+526143543923

Ruth S Favela Ortiz

Role: CONTACT

rfavelaortiz@gmail.com

+526142277559

Other Identifiers

029C-06/23

Identifier Type: -

Identifier Source: org_study_id