Soluble and Osmotic Fibre (SOLOS) Diet for Constipation (SOLOS)

February 4, 2026 updated by: Wilson Bridgette Jane, Singapore Institute of Technology

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.

Study Overview

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

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients (18-70 years old) with functional bowel disorders with constipation from the UK, seen by a specialist dietitian (Principal Investigator)

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • soluble fibre and osmotic carbohydrates diet
  • soluble fibre and osmotic carbohydrates (SOLOS) diet
  • SOLOS diet
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:
  • soluble fibre and osmotic carbohydrates diet
  • soluble fibre and osmotic carbohydrates (SOLOS) diet
  • SOLOS diet

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bridgette J Wilson, Dr, Singapore Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 2, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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