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

NCT05941650 | Not Yet Recruiting DMC

• 1 other identifier: 029C-06/23
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

Irritable Bowel Syndrome; SC-FOS; Prebiotics

Outcome Measures

Primary Outcomes (3)

• Score of IBS-QOL

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

  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

• Score of IBS-SSS

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

  10 days

Study Arms (2)

Short Chain Fructooligosaccharides Group

EXPERIMENTAL

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

Group

PLACEBO COMPARATOR

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

Interventions

Short Chain Fructooligosaccharides DIETARY_SUPPLEMENT

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

Also known as: Prebiotics

Short Chain Fructooligosaccharides Group

Corn Starch OTHER

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

Also known as: Placebo

Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Autonoma de Chihuahua: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Prebiotics; Starch

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages; Glucans; Biopolymers; Polymers; Macromolecular Substances

Study Officials

• Luis B Enríquez Sánchez

  Universidad Autonoma de Chihuahua

  STUDY DIRECTOR

Central Study Contacts

Carolina Martinez Loya

CONTACT

+526143543923; caromtzloya@gmail.com

Ruth S Favela Ortiz

CONTACT

+526142277559; rfavelaortiz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Médico Pasante de Servicio Social

Model Details: Prospective study, randomized single blind clinical trial

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 12, 2023
• Study Start: December 2, 2024
• Primary Completion: May 10, 2025
• Study Completion: May 30, 2025
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available for up to five years since completion of the study.
• Access Criteria: The request for the data will be by e-mail.