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

Last updated: February 1, 2024
Sponsor: Universidad Autonoma de Chihuahua
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Colic

Gastrointestinal Diseases And Disorders

Constipation

Treatment

Corn Starch

Short Chain Fructooligosaccharides

Clinical Study ID

NCT05941650
029C-06/23
  • Ages 18-65
  • Female
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: Corn Starch
Phase:
Study Start date:
December 02, 2024
Estimated Completion Date:
May 30, 2025

Study 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.).