To Study the Effect of Short-chain Fructooligosaccharides in Women With Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome, Diarrhea- Irritable Bowel Syndrome, Constipation-predominant Irritable Bowel Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Short Chain Fructooligosaccharides
Corn Starch
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, SC-FOS, Prebiotics
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Short Chain Fructooligosaccharides Group
Group
Arm Description
This group will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours for 10 days, diluted in 250 ml
This group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml
Outcomes
Primary Outcome Measures
Score of IBS-QOL
Score obtained in the questionnaire Irritable Bowel Syndrome - Quality of Life
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.
Score of IBS-SSS
Score obtained in the questionnaire Irritable Bowel Syndrome - Severity Scoring System
Secondary Outcome Measures
Full Information
NCT ID
NCT05941650
First Posted
July 3, 2023
Last Updated
August 19, 2023
Sponsor
Universidad Autonoma de Chihuahua
1. Study Identification
Unique Protocol Identification Number
NCT05941650
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 10, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de Chihuahua
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Diarrhea- Irritable Bowel Syndrome, Constipation-predominant Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, SC-FOS, Prebiotics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective study, randomized single blind clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Short Chain Fructooligosaccharides Group
Arm Type
Experimental
Arm Description
This group will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours for 10 days, diluted in 250 ml
Arm Title
Group
Arm Type
Placebo Comparator
Arm Description
This group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml
Intervention Type
Dietary Supplement
Intervention Name(s)
Short Chain Fructooligosaccharides
Other Intervention Name(s)
Prebiotics
Intervention Description
The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water.
Intervention Type
Other
Intervention Name(s)
Corn Starch
Other Intervention Name(s)
Placebo
Intervention Description
This group will receive 12 g of corn starch as a control group.
Primary Outcome Measure Information:
Title
Score of IBS-QOL
Description
Score obtained in the questionnaire Irritable Bowel Syndrome - Quality of Life
Time Frame
10 days
Title
Score of Bristol Scale
Description
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.
Time Frame
10 days
Title
Score of IBS-SSS
Description
Score obtained in the questionnaire Irritable Bowel Syndrome - Severity Scoring System
Time Frame
10 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Martinez Loya
Phone
+526143543923
Email
caromtzloya@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth S Favela Ortiz
Phone
+526142277559
Email
rfavelaortiz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis B Enríquez Sánchez
Organizational Affiliation
Universidad Autonoma de Chihuahua
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data obtained from this research study will be available if requested once the study is finalized.
IPD Sharing Time Frame
The data will be available for up to five years since completion of the study.
IPD Sharing Access Criteria
The request for the data will be by e-mail.
Learn more about this trial
To Study the Effect of Short-chain Fructooligosaccharides in Women With Irritable Bowel Syndrome
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