NCT07388589

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

January 28, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

January 28, 2026

Last Update Submit

February 4, 2026

Conditions

Keywords

ConstipationFunctional constipationConstipation-predominant irritable bowel syndrome (IBS-C)Soluble fiberosmotic sugar

Outcome Measures

Primary Outcomes (4)

  • Stool frequency

    Frequency of stool output per week

    January 2021 to December 2025

  • Stool form

    Bristol Stool Form Scale

    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.

    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).

    January 2021 to December 2025

Study Arms (2)

Patients with Functional Constipation

Other: Diet

Patients with IBS-C or SIBO-C

Other: Diet

Interventions

DietOTHER

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

Also known as: soluble fibre and osmotic carbohydrates diet, soluble fibre and osmotic carbohydrates (SOLOS) diet, SOLOS diet
Patients with Functional ConstipationPatients with IBS-C or SIBO-C

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Institute of Technology

Singapore, Singapore, 828608, Singapore

Location

MeSH Terms

Conditions

Constipation

Interventions

Diet

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Bridgette J Wilson, Dr

    Singapore Institute of Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 5, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Locations