ConstipationSOLOSNCT07388589
Soluble and Osmotic Fibre (SOLOS) Diet for Constipation
An observational study of Constipation and Constipation - Functional, run by Singapore Institute of Technology at 1 site in Singapore.
Trial summary
This research aims to study the dual effectiveness of incorporating soluble fibre and osmotic carbohydrates (SOLOS), with or without restricting fructans and GOS, and present novel findings in managing GI symptoms in patients with functional bowel disorders with constipation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Constipation, Constipation - Functional, Constipation Chronic Idiopathic
- What is being tested?
- Diet
- How many people
- 180 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Feb 2026to 1 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (18-70 years old) with functional bowel disorders with constipation from the UK, seen by a specialist dietitian (Principal Investigator)
Who may be able to join
- Presented with symptoms of FC, IBS-C, or SIBO-C
- Were aged 18 to 70 years old. (Research focus is on adult patients, excluding older adults and children)
- Date of baseline (first) and follow-up appointments ranged from January 2021 to December 2025
- Did not attend follow-up appointments (Data would be treated as "intention to treat" and data points were carried forward for conservative analysis).
Who cannot join
- Had no history of constipation-related symptoms (Does not relate to research question's population or outcome)
- Started treatment before January 2021
- Were not due for follow-up before the end of December 2025
- Symptom and stool data inadequately recorded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
Singapore Institute of Technology
Singapore, Singapore, 828608
Bridgette J Wilson, Dr, +65 82629995, bridgette.wilson@singaporetech.edu.sg
About this study
Official title: The Soluble and Osmotic Fibre (SOLOS) Diet for Functional Bowel Disorders With Constipation
This research aims to study the dual effectiveness of incorporating soluble fibre and osmotic carbohydrates (SOLOS), with or without restricting fructans and GOS, and present novel findings in managing GI symptoms in patients with functional bowel disorders with constipation. These findings may also support researchers and clinicians in shaping new dietary approaches in the management of general constipation symptoms.
Read the detailed description
Aims: This retrospective clinical audit study aims to evaluate the effectiveness of dietary advice promoting increased intake of soluble fibre and poorly absorbed (osmotic) carbohydrates, with or without restriction of fructans and galacto-oligosaccharides (GOS), on adult patients (18-70 years old) with functional bowel disorders with constipation from the UK by comparing to baseline scores for severity and frequency of gastrointestinal symptoms and stool output.
Hypothesis: The dietary advice promoting increased intake of soluble fibre and osmotic sugars will produce a significant change from baseline in gastrointestinal symptoms and stool output in adult patients (18-70 years old) with functional bowel disorders with constipation from the UK.
Methodology: The study population will include all patients who have consulted with the Principal Investigator, a specialist gastroenterology dietitian between January 2021 and December 2025. All patients who have met the inclusion criteria will then form the research sample. Eligible subjects' data and study variables will be extracted from patient letters and clinical management records without direct patient contact. These study variables include the frequency and severity of the patients' symptoms at their initial appointment and follow-up appointment if available. Anthropometric data such as height and weight will also be obtained. The compiled data will then be analysed by conducting statistical tests, specifically the paired t-test, which will produce descriptive statistics that will interpret the effectiveness of the SOLOS diet on patients with functional bowel disorders with constipation.
Applications: To date, there has not been any study studying the dual effects of soluble fibre and osmotic carbohydrates consumption on alleviating constipation-related symptoms in patients with functional bowel disorders with constipation. Therefore, this research aims to present novel findings that can advance existing dietary management of functional bowel disorders with constipation. These results are expected to deepen understanding and research in food manufacturing and clinical nutrition.
- Conditions
- Constipation, Constipation - Functional, Constipation Chronic Idiopathic, Constipation Predominant Irritable Bowel Syndrome, Constipation, Signs and Symptoms, Digestive, Constipation-predominant IBS (IBS-C)
- Being tested
- Diet
- Keywords
- Constipation, Functional constipation, Constipation-predominant irritable bowel syndrome (IBS-C), Soluble fiber, osmotic sugar
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Also called soluble fibre and osmotic carbohydrates diet, soluble fibre and osmotic carbohydrates (SOLOS) diet, SOLOS diet
Dietary advice combining increased intake of dietary sources of soluble fibres and osmotic sugars in improving constipation symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Functional Constipation | Not described Receives: Other: Diet | |
| Patients with IBS-C or SIBO-C | Not described Receives: Other: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency
Frequency of stool output per week
Measured: January 2021 to December 2025
Stool form
Bristol Stool Form Scale
Measured: January 2021 to December 2025
Gastrointestinal Symptom Frequency
Frequency of gastrointestinal symptom in a week, recorded as number of days out of 7 the symptom occurred over the past week.
Measured: January 2021 to December 2025
Gastrointestinal Symptom Severity
Severity of symptoms in a week scored using Gastrointestinal Symptom Rating Scale (GSRS). Scores range from 0 (absent) to 3 (severe).
Measured: January 2021 to December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start2 Feb 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wilson Bridgette Jane, Singapore Institute of Technology
- Investigators
- Bridgette J Wilson, Dr, Principal investigator, Singapore Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388589
- Sponsor's protocol ID
- RECAS-0723-IRB
- Acronym
- SOLOS
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Soluble and Osmotic Fibre (SOLOS) Diet for Functional Bowel Disorders With Constipation
- ClinicalTrials.gov ID
- NCT07388589
- Acronym / sponsor ID
- SOLOS / RECAS-0723-IRB
- Conditions
- Constipation, Constipation - Functional, Constipation Chronic Idiopathic, Constipation Predominant Irritable Bowel Syndrome, Constipation, Signs and Symptoms, Digestive, Constipation-predominant IBS (IBS-C)
- Keywords
- Constipation, Functional constipation, Constipation-predominant irritable bowel syndrome (IBS-C), Soluble fiber, osmotic sugar
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Singapore Institute of TechnologyUniversity, hospital or other
- Study start
- 2 Feb 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 5 Feb 2026 (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.
This research aims to study the dual effectiveness of incorporating soluble fibre and osmotic carbohydrates (SOLOS), with or without restricting fructans and GOS, and present novel findings in managing GI symptoms in patients with functional bowel disorders with constipation. These findings may also support researchers and clinicians in shaping new dietary approaches in the management of general constipation symptoms.
Detailed description
Aims: This retrospective clinical audit study aims to evaluate the effectiveness of dietary advice promoting increased intake of soluble fibre and poorly absorbed (osmotic) carbohydrates, with or without restriction of fructans and galacto-oligosaccharides (GOS), on adult patients (18-70 years old) with functional bowel disorders with constipation from the UK by comparing to baseline scores for severity and frequency of gastrointestinal symptoms and stool output.
Hypothesis: The dietary advice promoting increased intake of soluble fibre and osmotic sugars will produce a significant change from baseline in gastrointestinal symptoms and stool output in adult patients (18-70 years old) with functional bowel disorders with constipation from the UK.
Methodology: The study population will include all patients who have consulted with the Principal Investigator, a specialist gastroenterology dietitian between January 2021 and December 2025. All patients who have met the inclusion criteria will then form the research sample. Eligible subjects' data and study variables will be extracted from patient letters and clinical management records without direct patient contact. These study variables include the frequency and severity of the patients' symptoms at their initial appointment and follow-up appointment if available. Anthropometric data such as height and weight will also be obtained. The compiled data will then be analysed by conducting statistical tests, specifically the paired t-test, which will produce descriptive statistics that will interpret the effectiveness of the SOLOS diet on patients with functional bowel disorders with constipation.
Applications: To date, there has not been any study studying the dual effects of soluble fibre and osmotic carbohydrates consumption on alleviating constipation-related symptoms in patients with functional bowel disorders with constipation. Therefore, this research aims to present novel findings that can advance existing dietary management of functional bowel disorders with constipation. These results are expected to deepen understanding and research in food manufacturing and clinical nutrition.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Functional Constipation | – | Other: Diet |
| Patients with IBS-C or SIBO-C | – | Other: Diet |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (18-70 years old) with functional bowel disorders with constipation from the UK, seen by a specialist dietitian (Principal Investigator)
Key inclusion criteria (4 listed)
- Presented with symptoms of FC, IBS-C, or SIBO-C
- Were aged 18 to 70 years old. (Research focus is on adult patients, excluding older adults and children)
- Date of baseline (first) and follow-up appointments ranged from January 2021 to December 2025
- Did not attend follow-up appointments (Data would be treated as "intention to treat" and data points were carried forward for conservative analysis).
Key exclusion criteria (4 listed)
- Had no history of constipation-related symptoms (Does not relate to research question's population or outcome)
- Started treatment before January 2021
- Were not due for follow-up before the end of December 2025
- Symptom and stool data inadequately recorded
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 |
|---|---|---|
| DietAlso: soluble fibre and osmotic carbohydrates diet, soluble fibre and osmotic carbohydrates (SOLOS) diet, SOLOS dietDietary advice combining increased intake of dietary sources of soluble fibres and osmotic sugars in improving constipation symptoms. | Other | Patients with Functional Constipation, Patients with IBS-C or SIBO-C |
Primary outcome
Stool frequency
Time frame: January 2021 to December 2025
Frequency of stool output per week
Stool form
Time frame: January 2021 to December 2025
Bristol Stool Form Scale
Gastrointestinal Symptom Frequency
Time frame: January 2021 to December 2025
Frequency of gastrointestinal symptom in a week, recorded as number of days out of 7 the symptom occurred over the past week.
Gastrointestinal Symptom Severity
Time frame: January 2021 to December 2025
Severity of symptoms in a week scored using Gastrointestinal Symptom Rating Scale (GSRS). Scores range from 0 (absent) to 3 (severe).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Bridgette J Wilson, Dr principal investigator
Singapore Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Constipation and Constipation - Functional, run by Singapore Institute of Technology at 1 site in Singapore.
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 4 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: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bridgette J Wilson, Dr (+65 82629995, bridgette.wilson@singaporetech.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool frequency (time frame: January 2021 to December 2025). The study lists 4 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 6 Feb 2026.