- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07388589
Soluble and Osmotic Fibre (SOLOS) Diet for Constipation (SOLOS)
The Soluble and Osmotic Fibre (SOLOS) Diet for Functional Bowel Disorders With Constipation
Study Overview
Status
Conditions
- Constipation
- Diet Modification
- Constipation-predominant Irritable Bowel Syndrome
- Diet Therapy
- Constipation - Functional
- Constipation Chronic Idiopathic
- Constipation, Signs and Symptoms, Digestive
- Dietary Fiber
- Dietary Fibers
- Constipation Predominant Irritable Bowel Syndrome
- Dietary and Nutritional Therapies
- Constipation-predominant IBS (IBS-C)
- Diet, Food and Nutrition
- Constipation-predominant Irritable Bowel Syndrome (IBS-C)
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Bridgette J Wilson, Dr
- Phone Number: +65 82629995
- Email: bridgette.wilson@singaporetech.edu.sg
Study Locations
-
-
Singapore
-
Singapore, Singapore, Singapore, 828608
- Singapore Institute of Technology
-
Contact:
- Bridgette J Wilson, Dr
- Phone Number: +65 82629995
- Email: bridgette.wilson@singaporetech.edu.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with Functional Constipation
|
Dietary advice combining increased intake of dietary sources of soluble fibres and osmotic sugars in improving constipation symptoms.
Other Names:
|
|
Patients with IBS-C or SIBO-C
|
Dietary advice combining increased intake of dietary sources of soluble fibres and osmotic sugars in improving constipation symptoms.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stool frequency
Time Frame: January 2021 to December 2025
|
Frequency of stool output per week
|
January 2021 to December 2025
|
|
Stool form
Time Frame: January 2021 to December 2025
|
Bristol Stool Form Scale
|
January 2021 to December 2025
|
|
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.
|
January 2021 to December 2025
|
|
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).
|
January 2021 to December 2025
|
Collaborators and Investigators
Investigators
- Principal Investigator: Bridgette J Wilson, Dr, Singapore Institute of Technology
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECAS-0723-IRB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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