Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Martinez Loya | Contact | +526143543923 | caromtzloya@gmail.com | |
| Ruth S Favela Ortiz | Contact | +526142277559 | rfavelaortiz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luis B EnrÃquez Sánchez | Universidad Autonoma de Chihuahua | Study Director |
Not provided
The data obtained from this research study will be available if requested once the study is finalized.
The data will be available for up to five years since completion of the study.
The request for the data will be by e-mail.
Not provided
Not provided
Prospective study, randomized single blind clinical trial
Not provided
Not provided
Not provided
|
| Corn Starch | Other | This group will receive 12 g of corn starch as a control group. |
|
|
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D013213 | Starch |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
Not provided
Not provided