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

Universidad Autonoma de Chihuahua

Status: Not yet enrolling

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

Treatments: Dietary Supplement: Short Chain Fructooligosaccharides; Other: Corn Starch

Study type: Interventional

Funder types: Other

Identifiers

NCT05941650

029C-06/23

Details and patient eligibility

About

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).

Full 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.).

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Short Chain Fructooligosaccharides Group

Experimental group

Description:

This group will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours for 10 days, diluted in 250 ml

Treatment:

Dietary Supplement: Short Chain Fructooligosaccharides

Group

Placebo Comparator group

Description:

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

Treatment:

Other: Corn Starch