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

Study Overview
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Brief Summary
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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
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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.).

Official Title
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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.

Conditions
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Irritable Bowel Syndrome, Diarrhea- Irritable Bowel Syndrome, Constipation-predominant Irritable Bowel Syndrome

Intervention / Treatment
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* Dietary Supplement: Short Chain Fructooligosaccharides
* Other: Corn Starch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective study, randomized single blind clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short Chain Fructooligosaccharides Group<br>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<br>* The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water.<br>* Other names: Prebiotics;|
| Placebo Comparator: Group<br>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<br>* This group will receive 12 g of corn starch as a control group.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, SC-FOS, Prebiotics