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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
Universidad Autonoma de Chihuahua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, SC-FOS, Prebiotics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts 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

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

    First Posted
    July 3, 2023
    Last Updated
    August 19, 2023
    Sponsor
    Universidad Autonoma de Chihuahua
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    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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