Clinical trial NCT05941650: To Study the Effect of Short-chain Fructooligosaccharides in Women With Irritable Bowel Syndrome
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Irritable Bowel Syndrome
Diarrhea- Irritable Bowel Syndrome
Constipation-predominant Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
SC-FOS
Prebiotics
Lead sponsor: Universidad Autonoma de Chihuahua
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective study, randomized single blind clinical trial
Primary purpose: TREATMENT

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.).

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

Primary outcomes:
measure: Score of IBS-QOL
timeFrame: 10 days
measure: Score of Bristol Scale
timeFrame: 10 days
measure: Score of IBS-SSS
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Autonoma de Chihuahua
name: Luis B Enríquez Sánchez
role: STUDY_DIRECTOR
References: