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NCT Number: NCT07388589

Soluble and Osmotic Fibre (SOLOS) Diet for 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diet

Other

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

Primary outcomes

  1. Stool frequency

    Time frame: January 2021 to December 2025

    Frequency of stool output per week

  2. Stool form

    Time frame: January 2021 to December 2025

    Bristol Stool Form Scale

  3. 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.

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Bridgette J Wilson, Dr

CONTACT

[email protected]

+65 82629995

Sponsors and collaborators

Lead sponsor

Singapore Institute of Technology

Other

Registry information

Official study title

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

Acronym: SOLOS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 5, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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