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Not Yet RecruitingNCT07388589

Soluble and Osmotic Fibre (SOLOS) Diet for Constipation

The Soluble and Osmotic Fibre (SOLOS) Diet for Functional Bowel Disorders With Constipation

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
180 (estimated)
Sponsor
Singapore Institute of Technology · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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. 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.

Conditions

Interventions

TypeNameDescription
OTHERDietDietary advice combining increased intake of dietary sources of soluble fibres and osmotic sugars in improving constipation symptoms.

Timeline

Start date
2026-02-02
Primary completion
2027-03-01
Completion
2027-03-01
First posted
2026-02-05
Last updated
2026-02-06

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT07388589. Inclusion in this directory is not an endorsement.