Irritable Bowel SyndromeNCT05941650
To Study the Effect of Short-chain Fructooligosaccharides in Women With Irritable Bowel Syndrome
A study testing Short Chain Fructooligosaccharides and Corn Starch in people with Irritable Bowel Syndrome and Diarrhea- Irritable Bowel Syndrome, run by Universidad Autonoma de Chihuahua.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome, Diarrhea- Irritable Bowel Syndrome, Constipation-predominant Irritable Bowel Syndrome
- What is being tested?
- Short Chain Fructooligosaccharides and Corn Starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 2 Dec 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female sex
- Age 18 to 65 years
- Irritable Bowel Syndrome diagnosed by Rome Criterion
- Useful enteral feeding
Who cannot join
- Recent gastrointestinal disease < 2 weeks different to IBS
- Previous consumption of SC-FOS
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
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.
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).
Read the 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.).
- Conditions
- Irritable Bowel Syndrome, Diarrhea- Irritable Bowel Syndrome, Constipation-predominant Irritable Bowel Syndrome
- Being tested
- Short Chain Fructooligosaccharides, Corn Starch
- Keywords
- Irritable Bowel Syndrome, SC-FOS, Prebiotics
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Chain FructooligosaccharidesDietary supplement
Also called Prebiotics
The intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water.
Corn StarchOther
Also called Placebo
This group will receive 12 g of corn starch as a control group.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Short Chain Fructooligosaccharides |
| 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 Receives: Other: Corn Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of IBS-QOL
Score obtained in the questionnaire Irritable Bowel Syndrome - Quality of Life
Measured: 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.
Measured: 10 days
Score of IBS-SSS
Score obtained in the questionnaire Irritable Bowel Syndrome - Severity Scoring System
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start2 Dec 2024 (estimated)
- Primary completion10 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study, randomized single blind clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Chihuahua
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Martínez Loya, MD, Universidad Autonoma de Chihuahua
- Investigators
- Luis B Enríquez Sánchez, Study director, Universidad Autonoma de Chihuahua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941650
- Sponsor's protocol ID
- 029C-06/23
- Status last verified
- Feb 2024
- First submitted
- 3 Jul 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data obtained from this research study will be available if requested once the study is finalized.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05941650
- Acronym / sponsor ID
- 029C-06/23
- Conditions
- Irritable Bowel Syndrome, Diarrhea- Irritable Bowel Syndrome, Constipation-predominant Irritable Bowel Syndrome
- Keywords
- Irritable Bowel Syndrome, SC-FOS, Prebiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Autonoma de ChihuahuaUniversity, hospital or other
- Study start
- 2 Dec 2024 (estimated)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective study, randomized single blind clinical trial
| Arm | Type | Receives |
|---|---|---|
| Short Chain Fructooligosaccharides Group | Experimental | Dietary Supplement: Short Chain FructooligosaccharidesThis 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 | Other: Corn StarchThis group will receive Corn Starch as a Placebo control 12 gr. every 24 hours for 10 days, diluted in 250 ml |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female sex
- Age 18 to 65 years
- Irritable Bowel Syndrome diagnosed by Rome Criterion
- Useful enteral feeding
Key exclusion criteria (3 listed)
- Recent gastrointestinal disease < 2 weeks different to IBS
- Previous consumption of SC-FOS
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Chain FructooligosaccharidesAlso: PrebioticsThe intervention will receive Short-Chain Fructooligosaccharides at a dose of 12 gr. every 24 hours diluted in 250 ml of water. | Dietary supplement | Short Chain Fructooligosaccharides Group |
| Corn StarchAlso: PlaceboThis group will receive 12 g of corn starch as a control group. | Other | Group |
Primary outcome
Score of IBS-QOL
Time frame: 10 days
Score obtained in the questionnaire Irritable Bowel Syndrome - Quality of Life
Score of Bristol Scale
Time frame: 10 days
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
Time frame: 10 days
Score obtained in the questionnaire Irritable Bowel Syndrome - Severity Scoring System
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: Yes. The data obtained from this research study will be available if requested once the study is finalized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis B Enríquez Sánchez study director
Universidad Autonoma de Chihuahua
Questions about this trial
What is this clinical trial studying?
A study testing Short Chain Fructooligosaccharides and Corn Starch in people with Irritable Bowel Syndrome and Diarrhea- Irritable Bowel Syndrome, run by Universidad Autonoma de Chihuahua.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carolina Martinez Loya (+526143543923, caromtzloya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of IBS-QOL (time frame: 10 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024.